Autologous Myoblasts for the Treatment of Fecal Incontinence: Results of a Phase 2 Randomized Placebo-controlled Study (MIAS).

Objective: The aim of this study was to evaluate the efficacy of intrasphincteric injections of autologous myoblasts (AMs) in fecal incontinence (FI) in a controlled study.

Summary Of Background Data: Adult stem cell therapy is expected to definitively cure FI by regenerating damaged sphincter. Preclinical data and results of open-label trials suggest that myoblast therapy may represent a noninvasive treatment option.

A step toward NOTES total mesorectal excision for rectal cancer: endoscopic transanal proctectomy.

Background: Previous publications have suggested that endoscopic transanal proctectomy (ETAP) is a promising technique and may be an alternative to conventional low anterior resection for rectal cancer. The aim of this study was to evaluate the technical feasibility of ETAP, with a particular focus on postoperative and oncological results and on functional outcomes.

Methods: This study was a multicenter prospective study of unselected consecutive patients with low rectal cancer requiring proctectomy and coloanal anastomosis.

Elective operation after acute complicated diverticulitis: is it still mandatory?

Aim: To investigate recurrence rates, patterns and complications after nonoperatively managed complicated diverticulitis (CD).

Methods: A retrospective study of patients treated for CD was performed. CD was defined on computed tomography by the presence of a localized abscess, pelvic abscess or extraluminal air.

[Surgery for anal incontinence: developments in the past two decades and future directions].

Studies showing the frequency of anal incontinence and its social and economic impact have driven progress in surgical treatment, from muscle repair by myorraphy (mainly posterior myorraphy) or sphincteroplasty by direct suture of the external anal sphincter some 20 years ago, to invasive surgery with implantation of an artificial anal sphincter in 1993, mini-invasive surgery based on sacral nerve stimulation in 1998, failure of mini-invasive procedures with injection of a bulking agent or radiofrequency in 2000-2010, and development in 2012 of cellular therapy based on injection of autologous myoblasts. Progress in functional gut exploration (anorectal manometry, electrophysiological tests, endoanal ultrasonography, MRI, colonic transit time) and better knowledge of colonic and ano-rectal physiology will lead to further surgical advances.

Disclosure of funding sources and conflicts of interest in phase III surgical trials: survey of ten general surgery journals.

Background: Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI.

Methods: All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals.

Predictive factors for successful sacral nerve stimulation in the treatment of fecal incontinence: lessons from a comprehensive treatment assessment.

Background: Sacral nerve stimulation has a place in the treatment algorithm for fecal incontinence, but the predictive factors of its midterm and long-term success are unknown.

Objective: The purpose of this study was to investigate the effect of a 3-year sacral nerve stimulation treatment of fecal continence and to identify specific predictive factors from the pretreatment and per-treatment assessments for the midterm success of sacral nerve stimulation.

Design: A cohort analysis of consecutive patients treated with sacral nerve stimulation for fecal incontinence over a period of 3 years was performed.

[Surgical treatment of anal incontinence].

An epidemiologic assessment of the frequency of anal incontinence and the assessment of the social and economic impact of this handicap allowed progress of the surgery: muscular repair by myorraphy, mainly posterior myorraphy (postanal repair) or sphincteroplasty by direct suture of external anal sphincter, development of an invasive surgery by implantation of a neosphincter (artificial anal sphincter), development of mini-invasive surgery by sacral nerve stimulation, failure of mini-invasive procedures by injection of a bulking agent or radiofrequency, development of cellular therapy by injection of autologous myoblasts. In the same time, progress of digestive functional explorations (anorectal manometry, electrophysiological tests, endoanal ultra sonography, MRI, colonic transit time) and a better knowledge of colonic and ano-rectal physiology improved the surgical thought.

Transanal minimal invasive surgery with the Endorec(TM) trocar: a low cost but effective technique.

Purpose: Transanal endoscopic microsurgery (TEM) is a well-established surgical approach for local excision of benign adenomas and early-stage rectal cancer. This technique is expensive and associated with a long learning curve. To avoid these obstacles, we have developed an alternative approach using the Endorec(TM) trocar (Aspide, France), which combines the advantages of local transanal excision and single-port access.

Restoration of anal sphincter function after myoblast cell therapy in incontinent rats.

Fecal incontinence (FI) remains a socially isolating condition with profound impact on quality of life for which autologous myoblast cell therapy represents an attractive treatment option. We developed an animal model of FI and investigated the possibility of improving sphincter function by intrasphincteric injection of syngeneic myoblasts. Several types of anal cryoinjuries were evaluated on anesthetized Fischer rats receiving analgesics.

Reporting of ethical requirements in phase III surgical trials.

Background: Disclosure of obtaining informed consent from patients (ICP) and research ethics committee (REC) approval in published reports is sometimes omitted. To date, no disclosure data are available on surgical research.

Objective: Our aim was to assess whether REC approval and ICP were documented in surgical trials.

Hemophagocytic syndrome: an unusual and underestimated complication of cytoreduction surgery with heated intraperitoneal oxaliplatin.

Background: Hyperthermic intraperitoneal chemotherapy (HIPEC) improves the survival of select patients with peritoneal carcinomatosis. Hemophagocytic syndrome (HS) is a rare and potentially fatal disease. We describe our experience with five patients who developed HS following oxaliplatin HIPEC and propose a management procedure.

Methodological and ethical quality of randomized controlled clinical trials in gastrointestinal surgery.

Background: The randomized controlled trial (RCT) is the gold standard tool used to evaluate therapeutic interventions. Methodological and ethical aspects should be adequately reported to enable readers to make informed and justified judgments regarding the validity of a trial and the treatment effectiveness.

Objective: The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in gastrointestinal surgery and to assess the relationship between these two qualities.

Long term efficacy of gastric electrical stimulation in intractable nausea and vomiting.

Background: Although the efficacy of gastric electrical stimulation has been reported in short-term studies, there is a lack of data on the long-term improvement of nausea and vomiting by gastric electrical stimulation in patients with delayed or normal gastric emptying.

Methods: Thirty-one patients were implanted at our centre for medically refractory severe and chronic nausea and/or vomiting. Patients were evaluated at baseline, 6 months then 5 years after implantation (mean follow-up 80±4 months) using a symptomatic and quality of life scores.

[Rectal cancer: situation where a referral center is needed].

One of the objectives of the French strategic plan for cancer 2009-2013 is to structure the need for referral surgery, particularly for low rectal carcinoma. However, low rectal cancer is not the only situation in the field of rectal surgery where expert unit are needed for the referral of appropriate patients. We developed the multidisciplinary strategies for low rectal cancer, advanced rectal cancer, recurrent rectal cancer and peritoneal carcinomatosis.

Combined transanal and laparoscopic approach for the treatment of deep endometriosis infiltrating the rectum.

Background: Two surgical approaches are employed in the treatment of deep infiltrating endometriosis of the rectum (DIER): colorectal resection and nodule excision. In 2009, we introduced a new technique for transanal full thickness disc excision of endometriotic nodules infiltrating the low and middle rectum, using the Contour® Transtar™ stapler (Ethicon Endo-Surgery inc., Cincinnati, OH, USA).

Can sacral neuromodulation improve minor incontinence symptoms in doubly incontinent patients successfully treated for major incontinence symptoms?

Objective: To describe the effect of sacral nerve modulation (SNM) on less severe types of incontinence in patients who were successfully implanted for either urinary or fecal incontinence, and who presented with double incontinence. When conservative treatments fail, SNM is a first-line treatment for patients with urge urinary or fecal incontinence.

Methods: All patients who received SNM between 2005 and 2010 at 5 hospitals and who still had the implant were included in our survey.

Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence.

Background: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed.

Objective: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments.

Methods: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence.

Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial.

Background: Surgical management of left colonic cancer presenting as an acute obstruction remains controversial and still is associated with high mortality and morbidity rates. Recently, self-expandable metallic stents (SEMS) have been used as a bridge to surgery in an attempt to decompress the colon and then allow elective one-stage surgical resection without stoma placement. This study aimed to compare the outcomes of emergency surgery alone with emergency placement of colonic SEMS as a bridge to surgery in terms of efficiency and reduction of the stoma placement rate.

Surgical management of deep infiltrating endometriosis of the rectum: pleading for a symptom-guided approach.

Two surgical approaches are usually employed in the treatment of deep infiltrating endometriosis of the rectum (DIER): colorectal resection removing the rectal segment affected by the disease, and nodule excision either without opening the rectum (shaving) or by removing the nodule along with the surrounding rectal wall (full thickness or disc excision). Although the present available data are from retrospective series reported by surgeons who generally perform only one technique, there is no evidence to support the risk of recurrences as a valid argument in favour of colorectal resection over rectal nodule excision. The advantage of a lower morbidity associated with nodule excision is not necessarily at the cost of an increased rate of pain recurrences, especially in women benefiting from post-operative medical treatment.

Complications associated with two laparoscopic procedures used in the management of rectal endometriosis.

Background: To evaluate intra- and postoperative complications associated with laparoscopic management of rectal endometriosis by either colorectal segmental resection or nodule excision.

Methods: During 39 consecutive months, 46 women underwent laparoscopic management of rectal endometriosis and were included in a retrospective comparative study. The distinguishing feature of the study is that the choice of the surgical procedure is not related to the characteristics of the nodule.

Prognostic value of circulating mutant DNA in unresectable metastatic colorectal cancer.

Objective: No validated biologic prognostic marker is presently available in metastatic colorectal cancer (MCRC). We prospectively evaluated the prognostic value of circulating mutant DNA in 31 patients presenting an unresectable MCRC treated by chemotherapy, and we used, as tumor markers, KRAS mutations and methylation of the RASSF2A promoter.

Methods: Detection in the serum of KRAS mutation and RASSF2A methylation were performed using sensitive methods, respectively, real-time polymerase chain reaction (PCR) performed in the presence of a peptide nucleic acid specific of the wild-type sequence and methyl-specific PCR after bisulfite treatment.