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

ConditionVentral Hernia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mesh repair

    Procedure/Surgery

    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.

  • Suture repair

    Procedure/Surgery

    The hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.

Treatment groups

354 Participants
are divided into 2 treatment groups
Group A: Mesh groupExperimental treatment 1 intervention
Group B: Suture groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hernia recurrence rate, with or without surgical repair

Final diagnosis of hernia recurrence will be made by an endpoint committee of radiologists, blinded to the randomization arm (it is not possible to distinguish mesh from suture repair on CT-scans) on abdomino-pelvic CT-scan without contrast injection. Radiological hernia is defined as any protrusion of abdominal contents, including the anterior parietal peritoneum, visible as discontinuity of the fascial layers. In case of hernia recurrence requiring new VH repair during the study period (before the two years CT-scan evaluation), this will be considered as an event in intention-to-treat analysis.

Time frame
at 2 years

Secondary outcomes

1

Hernia recurrence rate at 1 year

Hernia recurrence rate clinically

Time frame
at 1 year
2

Reoperation rate for recurrence at 2 years

Reoperation rate for recurrence, at 2 years after randomization with medical files.

Time frame
at 2 years
3

Strangulated hernia rate at 1 year

Strangulated hernia rate (requiring emergent surgery), at 1 year after randomization (medical files)

Time frame
at 1 year
4

Surgical site infection rate at 1 year

Surgical site infection rate (superficial or deep), at 1 year after randomization (medical files)

Time frame
at 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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