The Effect of Laparoscopically Closing the Hernia Defect in Laparoscopic Ventral Hernia Repair on Postoperative Pain (CLOSE-GAP)

The Clinical Effects of Intracorporally Closure of the Hernia Defect in Laparoscopic Umbilical or Epigastric Hernia Repair

Introduction: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair. Beneficial effects of this technique have sporadically been reported but no evidence is available from randomized controlled trials.

The primary purpose is to compare early postoperative activity-related pain in patients undergoing ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are cosmesis and hernia-related quality of life (QoL) at 30-days and clinical or radiological recurrence and chronic pain after 2 years.

Material and Methods: A randomized, controlled, double-blinded study is planned. Based on power calculation we will include 40 patients in each arm. Patients undergoing elective laparoscopic umbilical, epigastric, or umbilical trocar-site hernia repair at Hvidovre Hospital, Herlev Hospital, or Køge Hospital, who meet the inclusion criteria, are invited to participate.

Conclusion: The technique with closure of the gap may induce more postoperative pain, but may be superior with regard to other important surgical outcomes. No studies have previously investigated closure of the gap in the setting of a randomised controlled trial.

Study Overview

• Status: Completed
• Conditions: Ventral Hernias
• Intervention / Treatment: Procedure: The hernia gap is sutured intracorporally

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria
• Elective, primary or recurrent laparoscopic umbilical or epigastric hernia repair, umbilical trocar-site hernia and epigastric hernia repair where laparoscopic hernia repair is no contraindication (i.e. previous laparotomy with anticipated severe and dense adhesions
• Hernia defect between 2-6 cm measured preoperatively by the surgeon at the out-patient clinic
• Maximum 1 defect
• Patients 18-80 years Patients with technical failure (where it is not possible to suture the defect) or patients who are reoperated due to complications remain included and will stay in their primary assigned randomization group in order to perform an intention to treat (ITT) analysis.

Exclusion Criteria:

• Open hernia repair
• Poor compliance (language problems, dementia and alcohol or drug abuse etc.)
• Fascia defect >6 cm (largest diameter, evaluated preoperatively and intra-operatively, thus patients are excluded if the defect is found larger intra-operatively)
• Emergency repair
• Chronic pain syndrome (chronic back pain, chronic headache, severe dysmenorrhea, fibromyalgia, whiplash or other conditions requiring daily opioid medication)
• Daily consumption of opioids (for the last 3 weeks up till the operation)
• Decompensated liver cirrhosis (Child-Pugh B-C)
• If the hernia repair is secondarily to another surgical procedure
• If a patient withdraws his/her inclusion consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sutured closure of the hernia gap; The hernia gap is sutured intracorporally	Procedure: The hernia gap is sutured intracorporally; The hernia gab is closed with non-absorbable suture (Ethibond Excel 2-0, Ethicon, Johnson & Johnson©) performed by an intracorporally interrupted sutured technique using an Auto Suture© Endo-Slide knot-tying instrument. The stitches are placed with a distance of 0.5 - 1 cm from the fascial edges and with a distance of 0.5-1 cm. between the stitches, performed under a 6-8 mmHg intrabdominal pressure.
No Intervention: No closure of the hernia gap; Physiomesh is placed with at least 5 cm overlap of the gap and fixated with double crown technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale	24 hrs postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Cosmetic result measured with verbal rating scale and numeric rating scales	measured 30 days postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia-specific quality of life	Measured with Carolina Comfort Scale (CCS)	measured 30 days postoperatively
complications, readmittance, and general practitioner visits	Measured with patient interview, and/or patient files	30-days postoperatively
clinical recurrence	clinical or radiological recurrence	2 years
chronic pain	moderate or severe chronic pain after 2 years	within 2 years

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Mette Christoffersen, M.D., Individual Purchaser

Publications and helpful links

General Publications

• Sauerland S, Walgenbach M, Habermalz B, Seiler CM, Miserez M. Laparoscopic versus open surgical techniques for ventral or incisional hernia repair. Cochrane Database Syst Rev. 2011 Mar 16;(3):CD007781. doi: 10.1002/14651858.CD007781.pub2.
• Christoffersen MW, Westen M, Rosenberg J, Helgstrand F, Bisgaard T. Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial. Br J Surg. 2020 Feb;107(3):200-208. doi: 10.1002/bjs.11490.
• Christoffersen MW, Westen M, Assadzadeh S, Deigaard SL, Rosenberg J, Bisgaard T. The clinical effects of closure of the hernia gap after laparoscopic ventral hernia repair: protocol for a randomised controlled trial. Dan Med J. 2014 Jun;61(6):A4865.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 14, 2013

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: CLOSE-GAP-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO