Innovative appliance for colostomy patients: an interventional prospective pilot study.

BACKGROUND: The control of body waste emptying is a constant research topic in stoma care. The aim of this pilot study was to assess the efficacy and safety of an innovative colostomy appliance. METHODS: An interventional prospective non-comparative pilot study was conducted in seven French centers. The study device is a new type of two-piece appliance including a base plate and a "capsule cap" (CC) composed of a capsule cover and a folded collecting bag. The device gently seals the stoma to provide stoma output control. When the bowel movement pressure increases the patient may control the deployment of the folded bag and collect stools. Patients with left-sided colostomy all using a flat appliance, were enrolled in a 2-week trial. Outcome measures were type of CC removal and peristomal fecal leaks while wearing the device. RESULTS: Of 30 patients (females 66.7%), with left-sided colostomy (permanent 76.7%), 23 (76.7%) completed the 2-week trial. A total of 472 CC changes were analyzed. EFFICACY: of 404 (85.5%) CC changes reported in diaries, 302 (74.8%) were linked with stool and/or gas. In 244 (60.3%) changes, the patient controlled stoma bag deployment and it occurred with bowel emptying 301 (74.5%) times. No leaks around the appliance were observed in 400 (85.3%) changes. SAFETY: no serious adverse event occurred. Peristomal skin was not modified during the trial. CONCLUSIONS: In the short term this new device has provided an increased control over bowel emptying at no risk in half of the trial population suggesting that an alternative approach to bag wearing is achievable.

Mid term functional results following surgical treatment of recto-urinary fistulas postprostate cancer treatment.

INTRODUCTION: To evaluate the mid term functional results of patients treated for RUF and to determine an optimal treatment strategy to improve their quality of life. Recto-urinary Fistula (RUF) is a rare complication following prostate cancer treatment, and can have a major impact on patients' quality of life. There is a lack of consensus concerning the best approach and different techniques have been proposed: endoscopic, transrectal, perineal and transperitoneal (open, laparoscopic or robotic). MATERIALS AND METHODS: We retrospectively reviewed the charts of patients who underwent RUF repair from January 2001 to December 2010 at our Institute. 16 patients who developed RUF following prostate cancer treatment were included in the study. The fistula had to be confirmed both clinically and by imaging. All patients had follow up consultation every 3 month for the first year and then annually. They were asked to fill questionnaires evaluating functional outcomes. The International Continence Society (ICS) score was used to assess the postoperative urinary continence. Fecal continence was evaluated with the Wexner score and sexual function was assessed with the International Index for erectile function (IIEF-5) score. RESULTS: Eighty-seven percent patients (14/16) in our series developed RUF as a consequence of prostate cancer surgery and 13% (2/16) postbrachytherapy (BT). All patients initially had a diversion colostomy and a supra pubic catheter. 69% (11/16) underwent primary YM repair and 73% (8/11) were successful. 2/3 primary failures were successfully retreated with graciloplasty. Primary gracilis flap interposition (GFI), on 3 non-irradiated patients were successful (100%). Primary GFI postbrachytherapy, no patient had recover urinary and digestive continuity. In total primary GIF was successful in 60% (3/5). Over all long term, success rate with a urinary and digestive continuity and without recurrence of the fistula was 81% (13/16). Mid term functional results were evaluated at mean follow up of 40 months (14-92). 13% (2/16) achieved complete urinary continence, 48% (7/16) required single pad, 25% (4/16) developed major incontinence, 7% (1/16) required urinary diversion and 13% (2/16) developed complete urethral closure post BT requiring permanent suprapubic catheterization. Colostomy was reversed in 93% (15/16) cases. 75% (12/16) achieved complete faecal continence, minor incontinence (wexner score 3-4) was seen in 13% (2/16) and major incontinence (wexner score 14) in 7% (1/16) and 7% (1/16) required a long term colostomy. 19% (3/16) developed colostomy related complications. Only 13% (2/16) achieved adequate erections with the use of intra cavernosal prostaglandin injections. CONCLUSIONS: RUF following prostate cancer treatment is a serious complication with severe repercussion on patients' quality of life. Surgical repair with the York Mason technique or Gracilis Flap interposition is associated with good success rates. If available pediculed gracilis muscle should be used as it offers better success rates. LEVEL OF EVIDENCE: 3.

Long-term outcome of robotic-assisted laparoscopic rectopexy for full-thickness rectal prolapse in elderly patients.

AIM: Full-thickness rectal prolapse is common in the elderly, but there are no particular practice guidelines for its surgical management. We evaluated retrospectively the perioperative and long-term clinical results and function in elderly and younger patients with complete rectal prolapse after robotic-assisted laparoscopic rectopexy (RALR). METHOD: Seventy-seven patients who underwent RALR between 2002 and 2010 were divided into Group A (age < 75 years, n = 59) and Group B (age > 75 years, n = 18). Operative time, intra- and postoperative complications, length of hospital stay, short-term and long-term outcomes, recurrence rate and degree of satisfaction were evaluated. RESULTS: There was no significant difference between the groups regarding operation time, conversion, morbidity or length of hospital stay. At a median follow-up of 51.8 (5-115) months, there was no difference in the improvement of faecal incontinence, recurrence and the degree of satisfaction. CONCLUSION: Robotic-assisted laparoscopic rectopexy is safe in patients aged over 75 years and gives similar results to those in patients aged < 75 years.

The effect of immune therapy on surgical site infection following Crohn's Disease resection.

BACKGROUND: Patients with Crohn's disease are increasingly receiving antitumour necrosis factor α (anti-TNF-α) therapy. Whether anti-TNF-α therapy increases the risk of postoperative infectious complications in Crohn's disease is a matter of debate. METHODS: This was a retrospective study of three referral centres. The charts of patients who underwent ileocaecal or ileocolonic resection for Crohn's disease between 2000 and 2011 were reviewed. The impact of baseline characteristics and Crohn's disease-related medications on the risk of postoperative intra-abdominal infectious complications was investigated by univariable and multivariable analysis. RESULTS: A total of 217 patients were included in the study. Median age at the time of surgery was 36·8 (range 15-78) years. A postoperative intra-abdominal infection occurred in 24 (11·1 per cent) of 217 patients. No deaths were reported. On univariable analysis, age less than 25 years (P = 0·023), steroid use (P = 0·017), anti-TNF-α therapy (P = 0·043) and anti-TNF-α treatment in combination with steroids (P = 0·004) were associated with an increased risk of postoperative intra-abdominal infectious complications. On multivariable analysis, only anti-TNF-α therapy in combination with steroids significantly increased this risk (odds ratio 8·03, 95 per cent confidence interval 1·93 to 33·43; P = 0·035). CONCLUSION: Combined use of steroids and anti-TNF-α therapy was associated with an increased risk of postoperative intra-abdominal infectious complications.

Long-term outcomes after totally robotic sacrocolpopexy for treatment of pelvic organ prolapse.

PURPOSE: This study evaluated the feasibility, safety, effectiveness, and long-term results of pelvic organ prolapse surgery using the Da Vinci robotic system. METHODS: During a 7-year period, 52 consecutive patients with pelvic organ prolapse underwent robotic-assisted abdominal sacrocolpopexy. Clinical data were retrospectively collected and analyzed. RESULTS: All but two of the procedures were successfully completed robotically (96 %). Median operative time was 190 (range, 75-340) mins. There was no mortality and no specific morbidity due to the robotic approach. Mean hospital stay was 5 days. The median follow-up was 42 months. Five recurrent prolapses (9.6 %) were diagnosed. CONCLUSIONS: Our experience indicates that using the Da-Vinci robotic system is feasible, safe, and effective for the treatment of pelvic organ prolapse with good long-term results.

Residency training in robotic surgery: The role of simulation.

Simulation has become increasingly important in surgical teaching in recent years and the French National Authority for Health (HAS) recently underlined the goal and ethical priority: "never the first time on the patient". Simulation programs have been tested and validated for laparotomy and for laparoscopy, but there is not yet a validated program specific for robotic surgery. Due to substantial advances in this new technology, we have developed a program in Nancy dedicated to outside-the-operating room (OR) teaching of robotic surgery using the Da Vinci robot. This teaching is based on a combined program of theoretical teaching (e-learning) and learning of practical skills using virtual simulators (DV-Trainer®, Robotic Mentor®, DVSS®), mechanical simulators (Dome, Applied® abdominal simulators), microsurgery and wet lab using ex vivo animal organs, anesthetized animals, and cadavers. This program also emphasizes team training. The course is intended for residents in surgical training and is integrated into the specialized study diploma (DES) program for Visceral and Digestive Surgery; it also can be used by qualified surgeons who can integrate it with the Inter-University Diploma (DIU) in General Robotic Surgery for basic techniques and also for DIUs in other surgical specialties (digestive and gynecologic surgery) for robotic uses within their specialty. These courses are based on the concept of step-by-step skills acquisition and verification allowing a transition to safe clinical activity.

Development of a program for teaching practical skills in visceral and digestive surgery by simulation.

Up until 2013 in France, practical training for DES/DESC (advanced level) residents in visceral and digestive surgery was not standardized. Since 2017, the third cycle of medical studies has been restructured around three major thematic axes: academic knowledge, and technical and non-technical skills. The curriculum now includes a practical training program by means of simulation outside the operating theater, and it is structured, uniformized and standardized nationwide. Development of this training program is derived from the deliberations of a national consensus panel working under the umbrella of the French college of visceral and digestive surgery, program presenting a training guide to all future surgeons in the specialty. Four consensus conference sessions bringing together an eight-member commission have led to the drafting of a "Resident's manual for practical teaching in visceral and digestive surgery". As a reference document, the manual details in 272 pages the objectives (phase I), the learning resources for each skill (phase II) and, lastly, the means of evaluation for the cornerstone phases as well as the in-depth phases of an advanced degree (DES) in visceral and digestive surgery. As a complement to the manual, we have conducted a review of the structuring and implementation of the program as of November 2017 on a nationwide scale; the conclusions of the review are detailed at the end of this article.

Sacral nerve stimulation in faecal incontinence: position statement based on a collective experience.

OBJECTIVE: Since the first paper published by Matzel et al., in 1995, on the efficacy of sacral nerve stimulation (SNS) in patients with faecal incontinence, the indications, the contraindications, the stimulation technique and follow up of implanted patients have changed. The aim of this article was to provide a consensus opinion on the management of patients with faecal incontinence treated with SNS. METHOD: Recommendations were based on a critical review of the literature when available and on expert opinions in areas with insufficient evidence. RESULTS: We have reviewed the indications and contraindications, proposed an algorithm for patient management showing the place of SNS. The temporary test technique, the implantation technique, the patient follow up and the approach in case of treatment failure were discussed. CONCLUSION: We hope not only to provide a guide on patient management to clinical practitioners interested in SNS but also to harmonize our practices.

Improvement in glycemic control by gastric electrical stimulation (TANTALUS) in overweight subjects with type 2 diabetes.

BACKGROUND: The TANTALUS system (MetaCure Ltd.) is a minimally invasive implantable gastric stimulation modality that does not exhibit malabsorptive or restrictive characteristics. The device applies gastric contractility modulation (GCM) signals to the stomach antrum. The signals are delivered in synchronization to the native electrical activity of the stomach during meals. Retrospective analysis of previous studies indicated that type 2 diabetes mellitus (T2DM) subjects on oral medication with hemoglobin A1c (HbA1c) between 7.5% and 9.5% are the population with most potential benefit from the treatment. The current study includes subjects enrolled prospectively within that range of HbA1c. AIM: To prospectively investigate the potential effect of the TANTALUS system on glycemic control and weight in overweight subjects with T2DM. METHODS: In this European multicenter, open-label study, 13 T2DM obese (6 male, 7 female, BMI 37.2 +/- 1.0 kg/m(2), range 30.4-44.0 kg/m(2)) subjects treated with oral antidiabetic medications but with poor glycemic control (HbA1c > or = 7%, range 7.3-9.5%) were implanted laparoscopically with the TANTALUS system. RESULTS: Thirteen subjects that had completed 3 months of treatment showed a significant reduction in HbA1c from 8.0 +/- 0.2% to 6.9 +/- 0.1% (p < 0.05), whereas fasting blood glucose decreased from 175 +/- 6 mg/dL to 127 +/- 8 mg/dL (p < 0.05). The glycemic improvement was accompanied by reduction in weight from 104.4 +/- 4.4 kg to 99.7 +/- 4.8 kg, and in waist circumference from 122.3 +/- 3.2 cm to 117.0 +/- 3.0 cm. CONCLUSIONS: Interim results with the TANTALUS system suggest that this stimulation regime can potentially improve glucose levels and induce moderate weight loss in obese T2DM subjects on oral antidiabetic therapy with poor glycemic control. Further evaluation is required to determine whether this effect is due to induced weight loss and/or due to direct signal-dependent mechanisms.

[Acute pancreatitis and primary hyperparathyroidism: a multicentric study by the Francophone Association of Endocrine Surgeons]. / Pancréatite aiguë et hyperparathyroïdie primaire: étude multicentrique de l'Association francophone de chirurgie endocrinienne.

BACKGROUND: Primary hyperparathyroidism is an unusual cause of acute pancreatitis. The aim of this study was to analyse data from multiple centers concerning patients with primary hyperparathyroidism and associated acute pancreatitis and to analyze potential predictive factors. METHODS: In this retrospective multicentric study, 19 patients were identified (Group A) with the associated diagnoses of acute pancreatitis and primary hyperparathyroidism. Their clinical data was compared to that of a control group of 65 patients (group B) with primary hyperparathyroidism without acute pancreatitis. RESULTS: Age, parathormone levels and pathology (uni/multiglandular disease) were similar between the two groups. The mean plasma calcium level was significantly higher in group A (12.64 mg/100ml) than in group B patients without pancreatitis (11.28 mg/100ml) (p<0.0001). CONCLUSION: This study confirms the causal relationship between primary hyperparathyroidism and acute pancreatitis. The degree of hypercalcemia may play an important role in this association. Calcium levels should be measured in all patients with acute pancreatitis.

What is the quality of information about bariatric surgery on the internet?

BACKGROUND: The purpose of this study was to evaluate the role of Internet on patients scheduled for bariatric procedures and the quality of information available on different websites. METHODS: Between July 2003 to July 2005, patients undergoing bariatric surgical procedures completed a survey. Data were collected prospectively. One hundred valid surveys were returned. Independently, two bariatric surgeons evaluated available French and English websites using major search engines. RESULTS: Forty-two of 100 patients (42%) sought information about bariatric surgery on the Internet. Seventy-four percent of these patients (n = 31/42) used search engines with 81% visiting less than ten websites. According to the patient's evaluation, 58% of the websites visited did not provide technical details of any surgical bariatric procedures, and only 61% provided information regarding postoperative weight loss. Furthermore, 58% of websites did not provide information about the laparoscopic approach, and 54% did not give any information on potential postoperative complications. Bariatric surgeon's evaluation was similar except for two differences: laparoscopic approach and postoperative weight loss information were discussed in 90% (p < 0.001) and 43% (p < 0.1) of visited websites, respectively. CONCLUSION: When the Internet was used to search for information about bariatric surgery, search engines were preferentially used but search duration was short. Available Internet websites can be considered as moderately reliable; however, 25% of visited websites contain misleading information. Comparison between patients and surgeons views showed that patients were effective in detecting misleading information.

[Da Vinci robot-assisted thoracoscopy for primary hyperparathyroidism: a new application in endocrine surgery]. / Thoracoscopie robotique pour hyperparathyroïdie primaire: nouvelle application en chirurgie endocrinienne.

Primary hyperparathyroidism is a relatively frequent disease whose incidence is often underestimated. It is caused by one or more hyperfunctioning parathyroid glands. Almost all pathologic glands (hyperplasia or adenoma) are located in the neck but 1-2% may be located in the mediastinum and may require a sternotomy or thoracotomy approach for resection. The thoracoscopic approach was proposed in 1994 and the DaVinci robotic system allows performance of this thoracoscopic procedure with the benefits of 3-dimensional vision, and improved surgical dexterity and ergonomics. We report a case of a patient with a parathyroid adenoma located in the aorto-pulmonary window which was resected using a left thoracoscopic approach aided by the Da Vinci robotic system.

Robot-assisted adrenalectomy: indications and drawbacks.

Adrenal tumors can vary from a benign adrenocortical adenoma with no hormonal secretion to a secretory adrenocortical malignancy (adrenocortical carcinoma) or a hormone-secreting tumor of the adrenal medulla (pheochromocytoma). Currently, laparoscopic adrenalectomy is regarded as the preferred surgical approach for the management of most adrenal surgical disorders, although there are no prospective randomized trials comparing this technique with open adrenalectomy. However, widespread adoption of robotic technology has positioned robotic adrenalectomy as an option in some medical centers. Speculative advantages associated with the use of the robotic system have rarely been evaluated in clinical settings and cost increase remains an important drawback associated with robotic surgery. This review summarizes current available data regarding robotic transperitoneal adrenalectomy including its indications, advantages, limitations, and comparison with conventional laparoscopic adrenalectomy. We believe that the use of a robotic system seems to be useful especially in more difficult patients with larger tumors, truncal paragangliomas, and bilateral and/or partial adrenalectomies. Overall, we believe that overcosts due to robotic system use could be balanced by hospital stay decrease, patients' referral increase, improved postoperative outcomes in more difficult patients and ergonomics for the surgeon. However, we also believe that the current surgical intuitive business model is counterproductive, because there are no available strong clinical data that could balance overcosts associated with the use of the robotic system.

[Open minimally invasive parathyroid and thyroid surgery]. / Mini-incisions pour thyroïdectomies et parathyroïdectomies.

Open minimally invasive parathyroidectomy or thyroidectomy (small-incision technique) are frequently performed. Benefits and disadvantages of this approach are discussed in this review. Preoperative patients selection is mandatory and is also discussed.

[Is radionuclide imaging still usefull for thyroid nodule management? A surgical point of view]. / La scintigraphie thyroïdienne est-elle encore utile pour la prise en charge d'un nodule thyroïdien? Le point de vue du chirurgien.

Preoperative management of thyroid nodule is still controversial. Since 25 years ago, preoperative evaluation of thyroid nodule has been modified and improved. The aim of this study was to review, from a surgical point of view, the role of radionuclide imaging results in the management of patients with thyroid nodules.

Prevalence of hepatic lesion types defined by T2-weighted and dynamic gadolinium-enhanced MR imaging in patients with metastasized neuroendocrine tumors.

PURPOSE: Identifying liver metastases from neuroendocrine tumors (NETs) is a pretherapeutic challenge in patients who are candidates for liver resection. The aims of our study are to characterize and determine the frequency of different MRI characteristics of liver metastases caused by NETs in a lesion-by-lesion analysis and to determine the frequency of monomorphous and polymorphous metastases in a patient-by-patient analysis. METHODS: This retrospective study involved 47 patients with liver metastases arising from histologically confirmed NETs. In a lesion-by-lesion analysis, we classified these metastases according to their MRI characteristics as follows: hypervascular lesions with homogeneous or peripheral enhancement, hypovascular lesions, pure cystic lesions, and mixed solid/cystic lesions. In the patient-by-patient analysis, we distinguished patients whose metastases had the same MRI characteristics from patients with mixed lesion characteristics. RESULTS: A total of 376 metastases were analyzed. Of these, 84.3% (n = 317) were hypervascular, with 51.9% showing homogeneous enhancement and 32.4% (n = 122) showing peripheral enhancement. Another 7.4% (n = 28) were hypovascular, 5.3% (n = 20) were pure cystic, and 2.9% (n = 11) were mixed solid/cystic. After excluding three patients with solitary lesions, 40.9% of patients (n = 18) had mixed-type lesions, consisting of hypervascular lesions with either homogeneous or peripheral enhancement in 27.3% of cases (n = 12), while 59.1% of patients (n = 26) had identical lesions. CONCLUSION: Approximately 15% of metastases have atypical MRI characteristics and are either hypovascular or cystic. Metastases with different MRI characteristics coexist in 40% of patients.

Robotic-assisted pelvic organ prolapse surgery.

BACKGROUND: This study describes technical aspect and short-term results of pelvic organ prolapse surgery using the da Vinci robotic system. METHODS: During a 1-year period, 18 consecutive patients with pelvic organ prolapse were operated on using the da-Vinci system. Clinical data were prospectively collected and analyzed. RESULTS: All but one procedure was successfully completed robotically (95%). Performed procedures were colpohysteropexy (n = 12), mesh rectopexy (n = 2), or sutured rectopexy combined with sigmoid resection (n = 4). Average setup time was 21 min and significantly decreased with experience. Mean operative time was 172 min (range, 45-280). There were no mortality and no specific morbidity due to the robotic approach. Mean hospital stay was 7 days. At 6 months, all patients were free of pelvic organ prolapse and stated that they were satisfied with anatomical and functional results. CONCLUSION: Our experience indicates that using the da-Vinci robotic system is feasible, safe, and effective for the treatment of pelvic organ prolapse.

Second-stage robot-assisted biliopancreatic diversion with duodenal switch after sleeve gastrectomy.

Biliopancreatic diversion (BPD) was initially described in 1979 and consisted of a distal gastrectomy with a 250-mL stomach pouch and a distal intestinal bypass with a 50 to 100-cm common channel resulting in malabsorption of dietary fat (Scopinaro et al. Br J Surg. 66(9):618-20, 1979). Later, several modifications (sleeve gastrectomy, pylorus preservation, and duodenal switch) were proposed to improve incidence of postoperative dumping syndrome, diarrhea, and anastomotic ulcerations (Lagacé et al. Obes Surg. 5(4):411-8, 1995). Gagner et al. developed a simplified and reproducible approach for laparoscopic BPD with duodenal switch (BPD-DS) after sleeve gastrectomy (Ren et al. Obes Surg. 10(6): 514-23, 2000). BPD-DS has been considered as one of the most difficult bariatric procedures for its surgical complexity and postoperative metabolic complications management. In this regard, the number of BPD-DS has remained extremely low (<4 %). We hypothesize that robotic approach could facilitate the feasibility of BPD-DS procedure. In this multimedia video (8 min), we present a step-by-step robotic BPD-DS.

Risk Factors for Postoperative Morbidity After Totally Robotic Gastric Bypass in 302 Consecutive Patients.

BACKGROUND: Totally robotic gastric bypass (robotic Roux-en-Y gastric bypass, R-RYGBP) has been adopted in some centers on the basis of large retrospective studies. In view of some data showing higher morbidity and higher costs, some authors have considered that robotic gastric bypass may no longer be justified with the existing system. Although low postoperative complication rates after R-RYGBP have been reported, risk factors for postoperative morbidity have never been evaluated. The goal of this study was to identify risk factors for postoperative morbidity after R-RYGBP. METHODS: A retrospective analysis of a prospectively maintained database was performed and included 302 consecutive patients after R-RYGBP performed between 2007 and 2013. This subset of patients represented 34 % of all gastric bypass procedures performed during this study period. Univariate and multivariate analyses were performed in order to identify risk factors for postoperative overall morbidity (Clavien scores 1-4 versus 0) and major morbidity (Clavien score ≥3 versus 0-1-2). RESULTS: Postoperative morbidity and mortality rates were 24.4 and 0.6 %, respectively. In multivariate analysis, independent risk factors for overall morbidity were American Society of Anesthesiologists (ASA) score ≥3 (odds ratio (OR) 2.0) and previous bariatric surgery (revisional gastric bypass) (OR 2.0). Independent risk factors for major morbidity (Clavien ≥3) were previous bariatric surgery (revisional gastric bypass) (OR 3.7), low preoperative hematocrit level (OR 0.9), and revisional gastric bypass procedure with concomitant gastric banding removal (OR 5.7). CONCLUSIONS: R-RYGBP is prone to increased complications in the setting of a high preoperative ASA score and revisional surgery. This should be taken into consideration by clinicians when evaluating R-RYGBP.