Multicenter prospective randomized study comparing the technique of using a bovine pericardium biological prosthesis reinforcement in parietal herniorrhaphy (Tutomesh TUTOGEN) with simple parietal herniorrhaphy, in a potentially contaminated setting.

The use of parietal synthetic prosthetic reinforcement material in potentially contaminated settings is not recommended, as there is a risk that the prosthesis may become infected. Thus, simple parietal herniorrhaphy, is the conventional treatment, even though there is a significant risk that the hernia may recur. Using new biomaterials of animal origin presently appears to offer a new therapeutic solution, but their effectiveness has yet to be demonstrated. The purpose of this multicenter prospective randomized single-blind study was to compare the surgical treatment of inguinal hernia or abdominal incisional hernia by simple parietal herniorrhaphy without prosthetic reinforcement (Group A), with Tutomesh TUTOGEN biological prosthesis reinforcement parietal herniorrhaphy (Group B), in a potentially contaminated setting. We examined early postoperative complications in the first month after the operation, performed an assessment after one year of survival without recurrence and analyzed the quality of life and pain of the patients (using SF-12 health status questionnaire and Visual Analog Pain Scale) at 1, 6, and 12 months, together with an economic impact study. Hundred and thirty four patients were enrolled between January 2009 and October 2010 in 20 French hospitals. The groups were comparable with respect to their enrollment characteristics, their history, types of operative indications and procedures carried out. At one month post-op, the rate of infectious complications (n(A) = 11(18.33%) vs. n(B) = 12(19.05%), p = 0.919) was not significantly different between the two groups. The assessment after one year of survival without recurrence revealed that survival was significantly greater in Group B (Group A recurrence: 10, Group B: 3; p = 0.0475). No difference in the patients' quality of life was demonstrated at 1, 6, or 12 months. However, at the 1 month follow-up, the "perceived health" rating seemed better in the group with Tutomesh (p = 0.022). No significant difference between the two parietal repair groups was observed during the follow-ups with respect to the criterion of pain (using a visual analog scale). There was a significant difference between the two parietal repair groups with regard to the number of days spent in intensive care unit, in favor of the Tutomesh technique (p = 0.010). The use of a Tutomesh bioprosthesis for hernia repair or postincisional hernia in a potentially contaminated workplace reduces the risk of short-term recurrence without increasing overall comorbidity.

Nissen Sleeve (N-Sleeve) operation: preliminary results of a pilot study.

BACKGROUND: Sleeve gastrectomy (SG) is one of the most frequently performed bariatric procedures worldwide. Despite its impressive results, there is a growing concern about the relationship between SG and gastroesophageal reflux disease (GERD). OBJECTIVES: We present our pilot study of patients operated with a Nissen anti-reflux valve added to a standard SG. SETTING: University hospital in Montpellier, France. METHODS: A prospective monocentric study including 25 consecutive patients operated with a laparoscopic Nissen-Sleeve (N-Sleeve) gastrectomy was carried out between September 2013 and March 2014. Inclusion criteria were indication for bariatric surgery for patients with GERD (Montreal's definition and classification). All patients were followed postoperatively for 1 year. RESULTS: There were 13 (54%) females and 12 (46%) males with mean age of 41±12 (20-65) years. Mean body mass index was 42±4.8 (35-53) kg/m2. Preoperatively, all patients had esophageal syndromes. Twenty-three (92%) patients had typical symptoms of GERD, but 2 were asymptomatic; however, they had esophageal injury. Esophagitis grade I-III presented in 10 (40%) patients and Barrett's esophagus in 8 (32%) cases. Two (8%) patients also had extraesophageal syndrome represented by asthma. Nineteen (76%) patients previously took proton pump inhibitors, regularly and 22 (88%) had experienced a hiatal hernia. There was no conversion to the open technique. Operative time was 84±13 (54-106) minutes. There were no deaths. Complications included one case of staple line bleeding and one Nissen valve perforation without recognized ischemia. No staple line failure was observed. Three months after N-Sleeve, 19 (76%) patients remained asymptomatic without proton pump inhibitor use. At 6 months and 1 year, 3 (12%) patients were still experiencing reflux. Excess weight loss at 1 year was 58±23%, total weight loss was 27±10%, and body mass index change was -11±4 kg/m². CONCLUSION: The N-Sleeve seems to be a safe procedure that provides an adequate reflux control with no clear interference on the expected bariatric results of a standard SG.