Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial

Официальное название

Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial

Обзор

The primary objective of the study is to demonstrate that hernia recurrence (VH) repair with non absorbable mesh concomitant to Bariatric Surgery (BS) decreases the risk of VH, with or without surgical repair, during the first two years after BS when compared to VH suture repair without mesh. As secondary objectives, the study aims to assess the impact of concomitant VH repair with non absorbable mesh versus suture repair in morbidly obese BS candidates on the following measures: - hernia recurrence at 1 year after randomization; - reoperation for hernia recurrence at 2 years after randomization; - strangulated hernia, surgical infection and mesh bulging at one year after randomization; - postoperative morbidity and mortality at 90 days after randomization; - benefit-risk ratio; - chronic pain at three months, six months, one year and two years after randomization; - quality of life during the two years after randomization; - incremental cost utility ratio; - short- and mid-term weight loss. To study if the efficacy of mesh versus suture VH repair differs according to the type and size of VH and to the surgical technique.

Подробное описание

This is a prospective, multicentric, superiority, comparative randomized (1:1) single-blinded clinical trial with blinded assessment of the primary endpoint.

Hypothesis for the study: abdominal ventral hernia (VH) repair with mesh during bariatric surgery (BS) is more effective than suture repair in preventing VH recurrence. Secondarily, we expect that mesh repair would not increase the risk of surgical site infection.

Population of study participants:

Patients between 18 and 60 years, presenting with VH and scheduled for BS, excluding pregnant women and protected adults.

All consecutive eligible patients will be invited to participate by visceral surgeons during preoperative consultations for BS. Included patients will be randomly assigned (1/1 ratio) to either mesh VH repair (intervention group) or suture VH repair (control group) by visceral surgeons at hospital admission (hospitalization or outpatient surgery) for BS and VH repair.

Patients will be followed according to clinical guidelines for BS follow-up at M1, M3, M6, M9, M12, M18 and M24 after BS.

There will be 29 surgical centers in France (digestive surgeons), targetting 354 eligible patients.

Statistical analysis:

An intention-to-treat statistical analysis will be performed at the end of the follow-up, when primary endpoint of all randomized patients will be documented.

The analysis for the primary endpoint will consist in comparing proportions of hernia recurrence during the two years after surgery between the two arms, using a Chi2 test.

An interim analysis is planned after half of the subjects finished their follow-up, in order to confirm the efficacy of the intervention arm, or alternatively its lack of efficacy.

Вмешательства

• Процедура Mesh repair
  Abdominal ventral hernia (VH) repair with mesh during bariatric surgery. the repair technique and the type of mesh are left to the choice of the center, as there are no strong data to demonstrate which technique is the best for VH repair in this population.
• Процедура Suture repair
  The hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.

Первичные конечные точки

• Hernia recurrence rate, with or without surgical repair [Срок оценки: at 2 years]

Вторичные конечные точки (12)

• Hernia recurrence rate at 1 year [Срок оценки: at 1 year]
• Reoperation rate for recurrence at 2 years [Срок оценки: at 2 years]
• Strangulated hernia rate at 1 year [Срок оценки: at 1 year]
• Surgical site infection rate at 1 year [Срок оценки: at 1 year]
• Mesh bulging rate at 2 years [Срок оценки: at 2 years]
• Postoperative morbidity rate [Срок оценки: daily up to 90 days]
• Postoperative mortality rate [Срок оценки: daily up to 90 days]
• Benefit-risk ratio [Срок оценки: at the end of the study]
• Self-reported chronic pain [Срок оценки: at 3 months, 6 months, 1 year and 2 years]
• Score of quality of life [Срок оценки: at 3 months, 6 months, 1 year and 2 years]
• Pain evaluation [Срок оценки: at 3 months, 6 months, 1 year and 2 years]
• Incremental cost utility ratio [Срок оценки: at 2 years]

Критерии участия

Критерии включения

• Patients between 18 and 60 years.
• Body Mass Index (BMI) ≥ 40 kg/m² or ≥ 35 kg/m² associated with at least one comorbidity that can improve after BS.
• Body Mass Index (BMI) < 50 kg/m².
• Primary or first recurrent incisional midline VH, umbilical or epigastric, width between 1 cm and 4 cm, on abdominopelvic CT-scan without contrast injection.
• Decision for primary sleeve gastrectomy or by-pass after multidisciplinary discussion.
• Request for BS approved by health insurance authorities.
• Written informed consent from patient.

Критерии исключения

• Previous VH repair with mesh.
• Other types of abdominal hernia (lateral, subxiphoidal, infraumbilical, suprapubic, parastomal, non-midline port-site, and groin hernia).
• Decision of performing BS by laparotomy.
• Reoperation for BS (excepted previous adjustable gastric banding).
• Ongoing abdominal skin infection.
• Emergency surgery.
• ASA (American Society of Anesthesiologists) score>3.
• Ongoing pregnancy or breast-feeding.
• Patient not covered by social insurance.
• Patient under legal guardianship.
• Patient already included in a clinical trial on hernia recurrence.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Department of visceral and digestive surgery, Louis Mourier hospital, APHP — Colombes

Идентификаторы

NCT: NCT05488288 · APHP211049 · 2023-A00658-37

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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