Peritoneal in Laparoscopic Ventral Hernia Repair 2

NCT04229940 | Completed Phase 2

• 1 other identifier: BriClo2
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic ventral hernia repair (VHR) is usually performed by reducing the contents in the hernia sac from the abdominal cavity and then covering the defect from the inside with a mesh, i.e. Intraperitoneal Onlay Mesh (IPOM). This means that the hernia sac is left in situ anterior to the mesh. This may, however, predispose for the development of fluid in the hernia sac, i.e. seroma. The risk of seroma development may be reduced if a the defect is closed before the mesh is applied. Closing the defect may, however, cause tension and pain from the abdominal wall. Instead of closing the defect, the part of the peritoneum constituting the hernia sac may be used for closing the defect. In this case, the peritoneum is dissected from the edges of the hernia sac and then used as a flap that is fixated to the edges of the hernia sac on the opposite side. In a previous study (BriClo), we compared defect closure as control group with peritoneal bridging. That study showed an increased risk for postoperative pain if the defect was closed. In order to evaluate whether peritoneal bridging reduces the seroma development following ventral hernia repair, we are undertaking a double-blind randomized controlled trial comparing no closure of the defect with peritoneal bridging. The goal is to randomize 100 patients undergoing laparoscopic ventral hernia repair. Clinical follow-up is performed three months, six months and one year after surgery. At all occasions, the patient is requested to fill in the Ventral Hernia Pain Questionnaire (VHPQ) and an investigation is done in order to assess the presence of seromas, recurrences or other local complications. Duration until return to work is registered. One year after surgery, computer tomography is performed in order to quantify the volume of seromas.

Conditions

Hernia, Ventral; Seroma as Procedural Complication

Keywords

Laparoscopy,; Hernia repair

Outcome Measures

Primary Outcomes (1)

• Seroma volume

  Volume of postoperative seroma measured with ultrasound

  One year

Secondary Outcomes (4)

• Postoperative complications

  30 days

• Postoperative pain

  One year

• Operative time

  3 hours

• Hernia recurrence

  One year

Study Arms (2)

Peritoneal bridging

EXPERIMENTAL

The peritoneum is dissected beginning 2-3 cm from the edge of the defect. The sac is dissected all the way to the opposite edge of the defect. The peritoneal flap is pulled to the opposite side and fixated with Optifix

Procedure: Peritoneal bridging

No bridging

ACTIVE COMPARATOR

The hernia defect is left without closure prior to application of the mesh.

Procedure: No peritoneal bridging

Interventions

Peritoneal bridging PROCEDURE

The defect is covered by peritoneal bridging

Peritoneal bridging

No peritoneal bridging PROCEDURE

The defect is left without bridging

No bridging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned for laparoscopic ventral hernia repair
• Defect size 3-10 cm
• BMI \<40

You may not qualify if:

• Defect size \>10 cm
• Ventral hernias with other localization than the midline
• Emergency surgery and incarcerated hernias
• Preoperative anticipation of extensive adhesions
• Pregnancy or intended pregnancy
• Serious comorbidity (ASA score \>3)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Örebro County: collaborator

Study Sites (1)

Department of Surgery, Karloskoga Hospital

Karlskoga, 69144, Sweden

Location

Related Publications (1)

• Ali F, Sandblom G, Forgo B, Wallin G. Peritoneal Bridging Versus Nonclosure in Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial. Ann Surg Open. 2023 Feb 2;4(1):e257. doi: 10.1097/AS9.0000000000000257. eCollection 2023 Mar.

  PMID: 37600866 DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient undergoing surgery and the physician performing the follow-up are masked to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-blind randomized controlled trial.

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: March 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)