Peritoneal Bridging in Laparoscopic Ventral Hernia Repair

NCT03344575 | Completed

• 1 other identifier: BriClo
• Study Type: interventional
• Target: 50
• 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 order to evaluate whether peritoneal bridging reduces the seroma development following ventral hernia repair, we are undertaking a double-blind randomized controlled trial comparing conventional closure of the hernia defect with peritoneal bridging. The goal is to randomize 50 patients undergoing laparoscopic ventral hernia to conventional closure or closure of the defect with peritoneal bridging. Clinical follow-up is performed one month and one year after surgery. At both 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. One year after surgery, computer tomography is performed. The main purpose of the computer tomography is to quantify the presence of seromas. The study is intended as phase 2 study with the aim of evaluating peritoneal bridging as an alternative to conventional defect closure. If the study shows that bridging does not lead to substantial seroma development, future studies with greater statistical power and other outcome measures will be undertaken.

Conditions

Hernia, Ventral; Laparoscopy; Seroma

Outcome Measures

Primary Outcomes (1)

• Seroma formation

  Volume of postoperative seroma measured with computer tomography

  One year

Secondary Outcomes (4)

• Postoperative complications

  30 days

• Postoperative pain

  One year

• Time required to close the defect

  3 hours

• Hernia recurrence

  One year

Study Arms (2)

Conventional defect closure

ACTIVE COMPARATOR

The defect is sutured with continuous PDS 2-0.

Procedure: Conventional defect closure

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

Interventions

Conventional defect closure PROCEDURE

Laparoscopic suturing of the defect prior to placing an intraperitoneal Onlay Mesh

Conventional defect closure

Peritoneal bridging PROCEDURE

Laparoscopic closure of the defect by using a peritoneal flap prior to placing an intraperitoneal Onlay Mesh

Peritoneal bridging

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Patients planned for laparoscopic repair of midline incisional hernia
• Defects with diameter 3-10 cm
• BMI\<40

You may not qualify if:

• Defect \>10 cm
• Ventral hernias with other localization than the midline
• Emergency surgery and incarcerated hernias
• Preoperative suspicion of extensive adhesions
• Pregnancy or intended pregnancy
• Serious comorbidity

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karlskoga Hospital: collaborator

Study Sites (1)

Department of Surgery, Karloskoga Hospital

Karlskoga, 69144, Sweden

Location

Related Publications (1)

• Ali F, Wallin G, Fathalla B, Sandblom G. Peritoneal bridging versus fascial closure in laparoscopic intraperitoneal onlay ventral hernia mesh repair: a randomized clinical trial. BJS Open. 2020 Aug;4(4):587-592. doi: 10.1002/bjs5.50305. Epub 2020 May 28.

  PMID: 32463163 DERIVED

MeSH Terms

Conditions

Hernia, Ventral; Seroma

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: November 12, 2017
• First Posted: November 17, 2017
• Study Start: July 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)