Surgical Endoscopy and Other Interventional Techniques, Nov 14, 2013
Background-During laparoscopic cholecystectomy, common bile duct (CBD) injury is a rare but sever... more Background-During laparoscopic cholecystectomy, common bile duct (CBD) injury is a rare but severe complication. To reduce the risk of injury, near-infrared (NIR) fluorescent cholangiography using indocyanine green (ICG) has recently been introduced as a novel method to visualize the biliary system during surgery. To date, several studies have shown feasibility of this technique. However, liver background fluorescence remains a major problem during fluorescent cholangiography. The aim of the current study was to optimize ICG dose and timing for NIR cholangiography using a quantitative intraoperative camera system during open hepatopancreatobiliary (HPB) surgery. Subsequently, these results were validated during laparoscopic cholecystectomy using a laparoscopic fluorescence imaging system. Methods-27 patients who underwent NIR imaging using the Mini-FLARE image-guided surgery system during open HPB surgery were analyzed to assess optimal dosage and timing of ICG administration. ICG was intravenously injected preoperatively at doses of 5, 10, and 20 mg, and imaged at either 30 min (early) or 24 h (delayed) post-injection. Next, the optimal doses found for early and delayed imaging were applied to 2 groups of 7 patients (n=14) undergoing laparoscopic NIR fluorescent cholangiography during laparoscopic cholecystectomy. Results-Median liver-to-background contrast was 23.5 (range: 22.1-35.0), 16.8 (range: 11.3-25.1), 1.3 (range: 0.7-7.8), and 2.5 (range: 1.3-3.6) for the 5 mg/30 min, 10 mg/30 min, 10 mg/24 h and 20 mg/24 h respectively. Fluorescence intensity of the liver was significantly lower in the 10 mg delayed imaging dose group compared to the early imaging 5 mg and 10 mg dose groups (P =
A swelling in the groin is a highly prevalent complaint. However, surgical exploration can someti... more A swelling in the groin is a highly prevalent complaint. However, surgical exploration can sometimes reveal an unexpected finding, such as in our case of a postmenopausal 52-year-old female patient. After surgical excision, a left groin mass appeared to be a leiomyoma of the round ligament of the uterus.
In this article we present a case of a 83-year-old female patient with an abnormal skin discolour... more In this article we present a case of a 83-year-old female patient with an abnormal skin discolouring around the colostomy, which we diagnosed as ectopic parastomal varices due to underlying primary biliary cirrhosis.
Background: Sacral nerve modulation (SNM) is a minimally invasive treatment for chronic constipat... more Background: Sacral nerve modulation (SNM) is a minimally invasive treatment for chronic constipation or incontinence when conservative treatment is insufficient to provide relieve of symptoms. Case description: A 74-year-old patient with an implanted sacral nerve lead is presented in this case report with a dislodged lead without an adverse change in her incontinence treatment. This phenomenon has never been described before and raises the debate on sacral lead positioning in sacral nerve stimulation. Discussion: There are a lot of conflicting data regarding ideal lead positioning, such as S3 versus S2 or S4 implantation. The lead position in our case doesn't correspond to previously described locations and pathways which corroborate the legitimacy of new developments in this area such as percutaneous tibial nerve stimulation, transcutaneous tibial nerve stimulation and transcutaneous abdominal electrical stimulation (TEN). Conclusions: The implantation of SNM seems standardized but leaves voids in the technique where further research is needed to refine it.
Assessment of microvessel density by immunohistochemical staining is subject to a considerable in... more Assessment of microvessel density by immunohistochemical staining is subject to a considerable inter-observer variation, and this has led to variability in correlation between microvessel density and clinical outcome in different studies. In order to improve the method of microvessel density measurement in tumour biopsies, we have developed a rapid, objective and quantitative method using flow cytometry on frozen tissues. Frozen tissue sections of archival tumour material were enzymatically digested. The single-cell suspension was stained for CD31 and CD34 for flow cytometry. The number of endothelial cells was quantified using light scatter-and fluorescence-characteristics. Tumour endothelial cells were detectable in a single cell suspension, and the percentage of endothelial cells detected in 32 colon carcinomas correlated highly (r=0.84, P50.001) with the immunohistochemical assessment of microvessel density. Flow cytometric endothelial cells quantification was found to be more sensitive especially at lower levels of immunohistochemical microvessel density measurement. The current method was found to be applicable for various tumour types and has the major advantage that it provides a retrospective and quantitative approach to the angiogenic potential of tumours.
Surgical site infections (SSI) are the most common postoperative complications. To minimize the r... more Surgical site infections (SSI) are the most common postoperative complications. To minimize the risk of SSI, there is a strict asepsis policy in the operating theatre. The aim of this study was to evaluate the risk and cost-saving benefit of performing perianal surgery in a non-sterile setting. All patients who had perianal surgery at our institution between January 2014 and December 2017 in a sterile (S) or non-sterile (NS) setting for an infectious or non-infectious cause were included. The primary outcome was the 30-day SSI rate. The secondary outcome was the reintervention rate. A questionnaire was sent to surgeons in the Netherlands to assess current policy with regard to asepsis in perianal procedures. Finally, a cost analysis was performed. In total, 376 patients were included. The rate of SSI in infectious procedures was 13% (S) versus 14% (NS, p = 0.853) and 5.1% (S) versus 0.9% (NS) in non-infectious procedures (p = 0.071). Reintervention rates in infectious procedures wer...
Fecal incontinence is a multifactorial problem and its etiology is complex. Various therapies are... more Fecal incontinence is a multifactorial problem and its etiology is complex. Various therapies are available and different success rates have been described. The aim of this study was to assess the effectiveness and safety of non-dynamic graciloplasty in patients with passive fecal incontinence. We retrospectively studied charts of patients with fecal incontinence treated with graciloplasty at our institution from November 2015 until June 2018. Patients were included according to the following criteria: (1) presence of predominantly passive fecal incontinence and (2) presence of a lax perineal body. Primary outcome was the effectiveness, defined as a significant reduction or absence of the complaints of passive fecal incontinence at 3, 6 and 12 months after surgery. Second, we studied the safety of the procedure evaluating the complications within 30 days after surgery. Thirty-one patients met the inclusion criteria. Twenty-six of them, in addition to passive incontinence as the main symptom, had some degree of fecal urgency. The median age at the first visit to the outpatient clinic was 64.0 years (IQR 52–68). Most patients were female (n = 29, 94%). At 3 months after graciloplasty, 71% (22 of 31) of patients were successfully treated for their passive fecal incontinence. At 6 months, the success rate of the graciloplasty increased to 77%. At 12 months among the patients who were still seen in the clinic, the success rate was 58% (18/31). Two patients cancelled follow-up visits after 3 months, because of failure to control symptoms in 1 case. After 6 months, 9 patients were given the choice to do telephone follow-up only. Of these 11 patients without in-person follow-up, 10 were contacted 1 year after surgery and in 7 of them, the graciloplasty was effective in controlling their passive fecal incontinence for an overall success rate of 80% (25/31). Of the 26 patients with mixed passive and urge incontinence, 6 (23%) still complained of urge incontinence at 1 year. Of these patients with persistent urge incontinence, 6 underwent sacral nerve stimulation which was successful in 4. Two serious complications occurred within 30 days. A rectal perforation requiring temporary colostomy and a recto-vaginal fistula which was successfully repaired. Non-dynamic graciloplasty is an effective treatment for passive fecal incontinence. Differentiation based on subtypes of fecal incontinence might be important for a pattern-specific approach to treatment. More research is necessary to determine the right indications for more invasive treatments of fecal incontinence.
Purpose The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patien... more Purpose The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant idiopathic slow-transit constipation is of suboptimal quality. The Dutch Ministry of Health, Welfare and Sports has granted conditional reimbursement for SNM treatment. The objective is to assess the effectiveness, cost-effectiveness, and budget impact of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment. Methods This study is an open-label, multicenter randomized controlled trial. Patients aged 14 to 80 with slow-transit constipation, a defecation frequency (DF) < 3 per week and meeting at least one other Rome-IV criterion, are eligible. Patients with obstructed outlet, irritable bowel syndrome, bowel pathology, or rectal prolapse are excluded. Patients are randomized to SNM or PCT. The primary outcome is success at 6 months (DF ≥ 3 a week), requiring a sample size of 64 (α = 0.05, β = 0.80, 30% difference in success). Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic quality of life, and costs at 6 months. Long-term costs and effectiveness will be estimated by a decision analytic model. The time frame is 57 months, starting October 2016. SNM treatment costs are funded by the Dutch conditional reimbursement program, research costs by Medtronic. Conclusions The results of this trial will be used to make a final decision regarding reimbursement of SNM from the Dutch Health Care Package in this patient group. Trial registration This trial is registered at clinicaltrials.gov, identifier NCT02961582, on 12 October 2016.
, et al., Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy ve... more , et al., Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial, Contemporary Clinical Trials (2020),
Sacral nerve modulation has become an established treatment for fecal and urinary incontinence, a... more Sacral nerve modulation has become an established treatment for fecal and urinary incontinence, and sexual disorders. The objective of this study was to evaluate the long-term outcome of sacral neuromodulation in patients with fecal or combined fecal and urinary incontinence (double incontinence), assessing its safety, efficacy, and impact on quality of life and sexual function. This was a multicentric, retrospective, cohort study including patients with fecal or double incontinence who received sacral neuromodulation at seven European centers between 2007 and 2017 and completed a 5-year follow-up. The main outcome measures included improvements of incontinence symptoms and quality of life compared with baseline, evaluated using validated tools and questionnaires at 1-, 6-, 12-, 36- and 60-month follow-up. 108 (102 women, mean age 62.4 ± 13.4 years) patients were recruited, of whom 88 (81.4%) underwent definitive implantation of the pacemaker. Patients’ baseline median Cleveland Cli...
Purpose Fecal incontinence (FI) is common, but its etiology is complex with large knowledge gaps.... more Purpose Fecal incontinence (FI) is common, but its etiology is complex with large knowledge gaps. Several phenotypes of FI are known, but the phenotype is often not decisive in the chosen therapy. In this study we aimed to assess the association of the clinical characteristics of patients with FI and the various phenotypes, in order to establish a targeted clinical treatment decision tree. Methods We retrospectively studied the charts of patients with FI, who visited our institute from January 2018 until December 2020. Patients were divided into the following groups: passive fecal loss, urge incontinence, combined fecal incontinence with predominantly passive fecal loss, and combined fecal incontinence with predominantly urge incontinence. We compared the characteristics between the passive and urge incontinence groups, the passive and combined mainly passive groups, and the urge and combined mainly urge groups. Results Patients with passive incintinence were older, more often had ...
Fecal incontinence has an enormous social and economic impact and may significantly impair qualit... more Fecal incontinence has an enormous social and economic impact and may significantly impair quality of life. Even though fecal incontinence is a common complaint in (aging) adults, a structured pathophysiological model of the clinical presentations of fecal incontinence is missing in current literature. The most frequent manifestations of fecal incontinence are passive fecal loss, urge incontinence, or mixed fecal incontinence. At our institution, we treat 400 patients per year with defecation disorders, including a significant number of patients with fecal incontinence. On the basis of this experience, we have tried to create a concept that merges current insight in causes and treatment options in a clinically useful algorithm. By applying the system of anamnesis and physical examination described in this article and expanding it with simple additional anorectal examination, in most patients, one can determine the type of fecal incontinence and choose a targeted therapy.
Importance The role of primary tumor resection (PTR) in synchronous patients with metastatic colo... more Importance The role of primary tumor resection (PTR) in synchronous patients with metastatic colorectal cancer (mCRC) who had unresectable metastases and few or absent symptoms of their primary tumor is unclear. Studying subgroups with low postoperative mortality may identify patients who potentially benefit from PTR. Objective To determine the difference in 60-day mortality between patients randomized to systemic treatment only vs PTR followed by systemic treatment, and to explore risk factors associated with 60-day mortality. Design, Setting, and Participants CAIRO4 is a randomized phase 3 trial initiated in 2012 in which patients with mCRC were randomized to systemic treatment only or PTR followed by systemic treatment with palliative intent. This multicenter study was conducted by the Danish and Dutch Colorectal Cancer Group in general and academic hospitals in Denmark and the Netherlands. Patients included between August 2012 and December 2019 with histologically proven colorectal cancer, unresectable metastases, and a primary tumor with few or absent symptoms were eligible. Interventions Systemic treatment, consisting of fluoropyrimidine-based chemotherapy with bevacizumab vs PTR followed by fluoropyrimidine-based chemotherapy with bevacizumab. Main Outcomes and Measures The aim of the current analysis was to compare 60-day mortality rates in both treatment arms. A secondary aim was the identification of risk factors for 60-day mortality in the treatment arms. These aims were not predefined in the study protocol. Results A total of 196 patients were included in the intention-to-treat analysis (112 [57%] men; median [IQR] age, 65 [59-70] years). Sixty-day mortality was 3% (95% CI, 1%-9%) in the systemic treatment arm and 11% (95% CI, 6%-19%) in the PTR arm (P = .03). In a per-protocol analysis, 60-day mortality was 2% (95% CI, 1%-7%) vs 10% (95% CI, 5%-18%; P = .048). Patients with elevated serum levels of lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, and/or neutrophils who were randomized to PTR had a significantly higher 60-day mortality than patients without these characteristics. Conclusions and Relevance Patients with mCRC who were randomized to PTR followed by systemic treatment had a higher 60-day mortality than patients randomized to systemic treatment. Especially patients randomized to the PTR arm with elevated serum levels of lactate dehydrogenase, neutrophils, aspartate aminotransferase, and/or alanine aminotransferase were at high risk of postoperative mortality. Final study results on overall survival have to be awaited. Trial Registration ClinicalTrials.gov Identifier: NCT01606098.
ABSTRACT PURPOSE Dynamic contrast-enhanced T1-weighted magnetic resonance imaging (DCE-MRI) using... more ABSTRACT PURPOSE Dynamic contrast-enhanced T1-weighted magnetic resonance imaging (DCE-MRI) using gadopentetate dimeglumine in mouse colorectal cancer models has demonstrated positive relationships between DCE-MRI derived parameters and histology. The purpose of this study was to evaluate DCE-MRI in monitoring effects of neoadjuvant radiation therapy in rectal cancer patients. METHOD AND MATERIALS DCE-MRI was performed in 18 patients with curable primary rectal cancer. Seven underwent a long course of preoperative radiation therapy (Long-RT) (25x 1.8 Gy), prior to DCE-MRI. Eleven did not, of whom, 3 underwent a short course of preoperative radiation therapy (Short -RT) (5x5 Gy), after MR imaging. DCE-MRI included pre-contrast T1-weighted measurements and a T1-W dynamic contrast-enhanced series of 250 dynamic volume acquisitions (duration of dynamic series, 10 minutes). A pharmacokinetic two-compartment model was used for calculating the microvessel transfer coefficient (KPS) and reflux (k) for the whole tumor volume. In addition, the extracellular extravascular space (EES) was defined as EES = KPS / k.Two observers independently scored microvessel density (CD31 and CD34 antibody) and tumor cell (Ki67) proliferation during the immunohistochemic analyses after surgery. RESULTS Long-RT resulted in significant reductions of 68% (p=.03) in KPS and 75% (p=.001) in k, and a 27% (ns, p=.1) increase in EES. Histology showed reductions of 34% in microvessel density (p=.04) and 55% (p=.002) in Ki67 positive tumor cells. The 3 patients who underwent short-RT after DCE-MRI, showed no differences in KPS, k or EES (p&gt;.3) compared to patients without RT, however, effects of RT were evident in histology: reduction of 53% (p=.02) in Ki76 positive tumor cells, but no reductions in MVD (p&gt;.5). CONCLUSIONS DCE-MRI combined with pharmacokinetic modeling showed effects of neoadjuvant radiation treatment in patients with curable primary rectal cancer. Reductions in KPS and k after a long course of radiation therapy probably reflect a combination of reduced tumor vascularity and increased EES, including edema and necrosis, secondary to radiation. Greater reductions in k than in KPS might be explained by the (ns) increase in EES.
Background: Sacral nerve modulation (SNM) is a minimally invasive treatment for chronic constipat... more Background: Sacral nerve modulation (SNM) is a minimally invasive treatment for chronic constipation or incontinence when conservative treatment is insufficient to provide relieve of symptoms. Case description: A 74-year-old patient with an implanted sacral nerve lead is presented in this case report with a dislodged lead without an adverse change in her incontinence treatment. This phenomenon has never been described before and raises the debate on sacral lead positioning in sacral nerve stimulation. Discussion: There are a lot of conflicting data regarding ideal lead positioning, such as S3 versus S2 or S4 implantation. The lead position in our case doesn't correspond to previously described locations and pathways which corroborate the legitimacy of new developments in this area such as percutaneous tibial nerve stimulation, transcutaneous tibial nerve stimulation and transcutaneous abdominal electrical stimulation (TEN). Conclusions: The implantation of SNM seems standardized but leaves voids in the technique where further research is needed to refine it.
Surgical Endoscopy and Other Interventional Techniques, Nov 14, 2013
Background-During laparoscopic cholecystectomy, common bile duct (CBD) injury is a rare but sever... more Background-During laparoscopic cholecystectomy, common bile duct (CBD) injury is a rare but severe complication. To reduce the risk of injury, near-infrared (NIR) fluorescent cholangiography using indocyanine green (ICG) has recently been introduced as a novel method to visualize the biliary system during surgery. To date, several studies have shown feasibility of this technique. However, liver background fluorescence remains a major problem during fluorescent cholangiography. The aim of the current study was to optimize ICG dose and timing for NIR cholangiography using a quantitative intraoperative camera system during open hepatopancreatobiliary (HPB) surgery. Subsequently, these results were validated during laparoscopic cholecystectomy using a laparoscopic fluorescence imaging system. Methods-27 patients who underwent NIR imaging using the Mini-FLARE image-guided surgery system during open HPB surgery were analyzed to assess optimal dosage and timing of ICG administration. ICG was intravenously injected preoperatively at doses of 5, 10, and 20 mg, and imaged at either 30 min (early) or 24 h (delayed) post-injection. Next, the optimal doses found for early and delayed imaging were applied to 2 groups of 7 patients (n=14) undergoing laparoscopic NIR fluorescent cholangiography during laparoscopic cholecystectomy. Results-Median liver-to-background contrast was 23.5 (range: 22.1-35.0), 16.8 (range: 11.3-25.1), 1.3 (range: 0.7-7.8), and 2.5 (range: 1.3-3.6) for the 5 mg/30 min, 10 mg/30 min, 10 mg/24 h and 20 mg/24 h respectively. Fluorescence intensity of the liver was significantly lower in the 10 mg delayed imaging dose group compared to the early imaging 5 mg and 10 mg dose groups (P =
A swelling in the groin is a highly prevalent complaint. However, surgical exploration can someti... more A swelling in the groin is a highly prevalent complaint. However, surgical exploration can sometimes reveal an unexpected finding, such as in our case of a postmenopausal 52-year-old female patient. After surgical excision, a left groin mass appeared to be a leiomyoma of the round ligament of the uterus.
In this article we present a case of a 83-year-old female patient with an abnormal skin discolour... more In this article we present a case of a 83-year-old female patient with an abnormal skin discolouring around the colostomy, which we diagnosed as ectopic parastomal varices due to underlying primary biliary cirrhosis.
Background: Sacral nerve modulation (SNM) is a minimally invasive treatment for chronic constipat... more Background: Sacral nerve modulation (SNM) is a minimally invasive treatment for chronic constipation or incontinence when conservative treatment is insufficient to provide relieve of symptoms. Case description: A 74-year-old patient with an implanted sacral nerve lead is presented in this case report with a dislodged lead without an adverse change in her incontinence treatment. This phenomenon has never been described before and raises the debate on sacral lead positioning in sacral nerve stimulation. Discussion: There are a lot of conflicting data regarding ideal lead positioning, such as S3 versus S2 or S4 implantation. The lead position in our case doesn't correspond to previously described locations and pathways which corroborate the legitimacy of new developments in this area such as percutaneous tibial nerve stimulation, transcutaneous tibial nerve stimulation and transcutaneous abdominal electrical stimulation (TEN). Conclusions: The implantation of SNM seems standardized but leaves voids in the technique where further research is needed to refine it.
Assessment of microvessel density by immunohistochemical staining is subject to a considerable in... more Assessment of microvessel density by immunohistochemical staining is subject to a considerable inter-observer variation, and this has led to variability in correlation between microvessel density and clinical outcome in different studies. In order to improve the method of microvessel density measurement in tumour biopsies, we have developed a rapid, objective and quantitative method using flow cytometry on frozen tissues. Frozen tissue sections of archival tumour material were enzymatically digested. The single-cell suspension was stained for CD31 and CD34 for flow cytometry. The number of endothelial cells was quantified using light scatter-and fluorescence-characteristics. Tumour endothelial cells were detectable in a single cell suspension, and the percentage of endothelial cells detected in 32 colon carcinomas correlated highly (r=0.84, P50.001) with the immunohistochemical assessment of microvessel density. Flow cytometric endothelial cells quantification was found to be more sensitive especially at lower levels of immunohistochemical microvessel density measurement. The current method was found to be applicable for various tumour types and has the major advantage that it provides a retrospective and quantitative approach to the angiogenic potential of tumours.
Surgical site infections (SSI) are the most common postoperative complications. To minimize the r... more Surgical site infections (SSI) are the most common postoperative complications. To minimize the risk of SSI, there is a strict asepsis policy in the operating theatre. The aim of this study was to evaluate the risk and cost-saving benefit of performing perianal surgery in a non-sterile setting. All patients who had perianal surgery at our institution between January 2014 and December 2017 in a sterile (S) or non-sterile (NS) setting for an infectious or non-infectious cause were included. The primary outcome was the 30-day SSI rate. The secondary outcome was the reintervention rate. A questionnaire was sent to surgeons in the Netherlands to assess current policy with regard to asepsis in perianal procedures. Finally, a cost analysis was performed. In total, 376 patients were included. The rate of SSI in infectious procedures was 13% (S) versus 14% (NS, p = 0.853) and 5.1% (S) versus 0.9% (NS) in non-infectious procedures (p = 0.071). Reintervention rates in infectious procedures wer...
Fecal incontinence is a multifactorial problem and its etiology is complex. Various therapies are... more Fecal incontinence is a multifactorial problem and its etiology is complex. Various therapies are available and different success rates have been described. The aim of this study was to assess the effectiveness and safety of non-dynamic graciloplasty in patients with passive fecal incontinence. We retrospectively studied charts of patients with fecal incontinence treated with graciloplasty at our institution from November 2015 until June 2018. Patients were included according to the following criteria: (1) presence of predominantly passive fecal incontinence and (2) presence of a lax perineal body. Primary outcome was the effectiveness, defined as a significant reduction or absence of the complaints of passive fecal incontinence at 3, 6 and 12 months after surgery. Second, we studied the safety of the procedure evaluating the complications within 30 days after surgery. Thirty-one patients met the inclusion criteria. Twenty-six of them, in addition to passive incontinence as the main symptom, had some degree of fecal urgency. The median age at the first visit to the outpatient clinic was 64.0 years (IQR 52–68). Most patients were female (n = 29, 94%). At 3 months after graciloplasty, 71% (22 of 31) of patients were successfully treated for their passive fecal incontinence. At 6 months, the success rate of the graciloplasty increased to 77%. At 12 months among the patients who were still seen in the clinic, the success rate was 58% (18/31). Two patients cancelled follow-up visits after 3 months, because of failure to control symptoms in 1 case. After 6 months, 9 patients were given the choice to do telephone follow-up only. Of these 11 patients without in-person follow-up, 10 were contacted 1 year after surgery and in 7 of them, the graciloplasty was effective in controlling their passive fecal incontinence for an overall success rate of 80% (25/31). Of the 26 patients with mixed passive and urge incontinence, 6 (23%) still complained of urge incontinence at 1 year. Of these patients with persistent urge incontinence, 6 underwent sacral nerve stimulation which was successful in 4. Two serious complications occurred within 30 days. A rectal perforation requiring temporary colostomy and a recto-vaginal fistula which was successfully repaired. Non-dynamic graciloplasty is an effective treatment for passive fecal incontinence. Differentiation based on subtypes of fecal incontinence might be important for a pattern-specific approach to treatment. More research is necessary to determine the right indications for more invasive treatments of fecal incontinence.
Purpose The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patien... more Purpose The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant idiopathic slow-transit constipation is of suboptimal quality. The Dutch Ministry of Health, Welfare and Sports has granted conditional reimbursement for SNM treatment. The objective is to assess the effectiveness, cost-effectiveness, and budget impact of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment. Methods This study is an open-label, multicenter randomized controlled trial. Patients aged 14 to 80 with slow-transit constipation, a defecation frequency (DF) < 3 per week and meeting at least one other Rome-IV criterion, are eligible. Patients with obstructed outlet, irritable bowel syndrome, bowel pathology, or rectal prolapse are excluded. Patients are randomized to SNM or PCT. The primary outcome is success at 6 months (DF ≥ 3 a week), requiring a sample size of 64 (α = 0.05, β = 0.80, 30% difference in success). Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic quality of life, and costs at 6 months. Long-term costs and effectiveness will be estimated by a decision analytic model. The time frame is 57 months, starting October 2016. SNM treatment costs are funded by the Dutch conditional reimbursement program, research costs by Medtronic. Conclusions The results of this trial will be used to make a final decision regarding reimbursement of SNM from the Dutch Health Care Package in this patient group. Trial registration This trial is registered at clinicaltrials.gov, identifier NCT02961582, on 12 October 2016.
, et al., Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy ve... more , et al., Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial, Contemporary Clinical Trials (2020),
Sacral nerve modulation has become an established treatment for fecal and urinary incontinence, a... more Sacral nerve modulation has become an established treatment for fecal and urinary incontinence, and sexual disorders. The objective of this study was to evaluate the long-term outcome of sacral neuromodulation in patients with fecal or combined fecal and urinary incontinence (double incontinence), assessing its safety, efficacy, and impact on quality of life and sexual function. This was a multicentric, retrospective, cohort study including patients with fecal or double incontinence who received sacral neuromodulation at seven European centers between 2007 and 2017 and completed a 5-year follow-up. The main outcome measures included improvements of incontinence symptoms and quality of life compared with baseline, evaluated using validated tools and questionnaires at 1-, 6-, 12-, 36- and 60-month follow-up. 108 (102 women, mean age 62.4 ± 13.4 years) patients were recruited, of whom 88 (81.4%) underwent definitive implantation of the pacemaker. Patients’ baseline median Cleveland Cli...
Purpose Fecal incontinence (FI) is common, but its etiology is complex with large knowledge gaps.... more Purpose Fecal incontinence (FI) is common, but its etiology is complex with large knowledge gaps. Several phenotypes of FI are known, but the phenotype is often not decisive in the chosen therapy. In this study we aimed to assess the association of the clinical characteristics of patients with FI and the various phenotypes, in order to establish a targeted clinical treatment decision tree. Methods We retrospectively studied the charts of patients with FI, who visited our institute from January 2018 until December 2020. Patients were divided into the following groups: passive fecal loss, urge incontinence, combined fecal incontinence with predominantly passive fecal loss, and combined fecal incontinence with predominantly urge incontinence. We compared the characteristics between the passive and urge incontinence groups, the passive and combined mainly passive groups, and the urge and combined mainly urge groups. Results Patients with passive incintinence were older, more often had ...
Fecal incontinence has an enormous social and economic impact and may significantly impair qualit... more Fecal incontinence has an enormous social and economic impact and may significantly impair quality of life. Even though fecal incontinence is a common complaint in (aging) adults, a structured pathophysiological model of the clinical presentations of fecal incontinence is missing in current literature. The most frequent manifestations of fecal incontinence are passive fecal loss, urge incontinence, or mixed fecal incontinence. At our institution, we treat 400 patients per year with defecation disorders, including a significant number of patients with fecal incontinence. On the basis of this experience, we have tried to create a concept that merges current insight in causes and treatment options in a clinically useful algorithm. By applying the system of anamnesis and physical examination described in this article and expanding it with simple additional anorectal examination, in most patients, one can determine the type of fecal incontinence and choose a targeted therapy.
Importance The role of primary tumor resection (PTR) in synchronous patients with metastatic colo... more Importance The role of primary tumor resection (PTR) in synchronous patients with metastatic colorectal cancer (mCRC) who had unresectable metastases and few or absent symptoms of their primary tumor is unclear. Studying subgroups with low postoperative mortality may identify patients who potentially benefit from PTR. Objective To determine the difference in 60-day mortality between patients randomized to systemic treatment only vs PTR followed by systemic treatment, and to explore risk factors associated with 60-day mortality. Design, Setting, and Participants CAIRO4 is a randomized phase 3 trial initiated in 2012 in which patients with mCRC were randomized to systemic treatment only or PTR followed by systemic treatment with palliative intent. This multicenter study was conducted by the Danish and Dutch Colorectal Cancer Group in general and academic hospitals in Denmark and the Netherlands. Patients included between August 2012 and December 2019 with histologically proven colorectal cancer, unresectable metastases, and a primary tumor with few or absent symptoms were eligible. Interventions Systemic treatment, consisting of fluoropyrimidine-based chemotherapy with bevacizumab vs PTR followed by fluoropyrimidine-based chemotherapy with bevacizumab. Main Outcomes and Measures The aim of the current analysis was to compare 60-day mortality rates in both treatment arms. A secondary aim was the identification of risk factors for 60-day mortality in the treatment arms. These aims were not predefined in the study protocol. Results A total of 196 patients were included in the intention-to-treat analysis (112 [57%] men; median [IQR] age, 65 [59-70] years). Sixty-day mortality was 3% (95% CI, 1%-9%) in the systemic treatment arm and 11% (95% CI, 6%-19%) in the PTR arm (P = .03). In a per-protocol analysis, 60-day mortality was 2% (95% CI, 1%-7%) vs 10% (95% CI, 5%-18%; P = .048). Patients with elevated serum levels of lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, and/or neutrophils who were randomized to PTR had a significantly higher 60-day mortality than patients without these characteristics. Conclusions and Relevance Patients with mCRC who were randomized to PTR followed by systemic treatment had a higher 60-day mortality than patients randomized to systemic treatment. Especially patients randomized to the PTR arm with elevated serum levels of lactate dehydrogenase, neutrophils, aspartate aminotransferase, and/or alanine aminotransferase were at high risk of postoperative mortality. Final study results on overall survival have to be awaited. Trial Registration ClinicalTrials.gov Identifier: NCT01606098.
ABSTRACT PURPOSE Dynamic contrast-enhanced T1-weighted magnetic resonance imaging (DCE-MRI) using... more ABSTRACT PURPOSE Dynamic contrast-enhanced T1-weighted magnetic resonance imaging (DCE-MRI) using gadopentetate dimeglumine in mouse colorectal cancer models has demonstrated positive relationships between DCE-MRI derived parameters and histology. The purpose of this study was to evaluate DCE-MRI in monitoring effects of neoadjuvant radiation therapy in rectal cancer patients. METHOD AND MATERIALS DCE-MRI was performed in 18 patients with curable primary rectal cancer. Seven underwent a long course of preoperative radiation therapy (Long-RT) (25x 1.8 Gy), prior to DCE-MRI. Eleven did not, of whom, 3 underwent a short course of preoperative radiation therapy (Short -RT) (5x5 Gy), after MR imaging. DCE-MRI included pre-contrast T1-weighted measurements and a T1-W dynamic contrast-enhanced series of 250 dynamic volume acquisitions (duration of dynamic series, 10 minutes). A pharmacokinetic two-compartment model was used for calculating the microvessel transfer coefficient (KPS) and reflux (k) for the whole tumor volume. In addition, the extracellular extravascular space (EES) was defined as EES = KPS / k.Two observers independently scored microvessel density (CD31 and CD34 antibody) and tumor cell (Ki67) proliferation during the immunohistochemic analyses after surgery. RESULTS Long-RT resulted in significant reductions of 68% (p=.03) in KPS and 75% (p=.001) in k, and a 27% (ns, p=.1) increase in EES. Histology showed reductions of 34% in microvessel density (p=.04) and 55% (p=.002) in Ki67 positive tumor cells. The 3 patients who underwent short-RT after DCE-MRI, showed no differences in KPS, k or EES (p&gt;.3) compared to patients without RT, however, effects of RT were evident in histology: reduction of 53% (p=.02) in Ki76 positive tumor cells, but no reductions in MVD (p&gt;.5). CONCLUSIONS DCE-MRI combined with pharmacokinetic modeling showed effects of neoadjuvant radiation treatment in patients with curable primary rectal cancer. Reductions in KPS and k after a long course of radiation therapy probably reflect a combination of reduced tumor vascularity and increased EES, including edema and necrosis, secondary to radiation. Greater reductions in k than in KPS might be explained by the (ns) increase in EES.
Background: Sacral nerve modulation (SNM) is a minimally invasive treatment for chronic constipat... more Background: Sacral nerve modulation (SNM) is a minimally invasive treatment for chronic constipation or incontinence when conservative treatment is insufficient to provide relieve of symptoms. Case description: A 74-year-old patient with an implanted sacral nerve lead is presented in this case report with a dislodged lead without an adverse change in her incontinence treatment. This phenomenon has never been described before and raises the debate on sacral lead positioning in sacral nerve stimulation. Discussion: There are a lot of conflicting data regarding ideal lead positioning, such as S3 versus S2 or S4 implantation. The lead position in our case doesn't correspond to previously described locations and pathways which corroborate the legitimacy of new developments in this area such as percutaneous tibial nerve stimulation, transcutaneous tibial nerve stimulation and transcutaneous abdominal electrical stimulation (TEN). Conclusions: The implantation of SNM seems standardized but leaves voids in the technique where further research is needed to refine it.
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