The Effect of Laparoscopically Closing the Hernia Defect in Laparoscopic Ventral Hernia Repair on Postoperative Pain

NCT01962480 | Completed DMC

• 1 other identifier: CLOSE-GAP-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventral Hernias

Outcome Measures

Primary Outcomes (1)

• Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale

  24 hrs postoperatively

Secondary Outcomes (1)

• Cosmetic result measured with verbal rating scale and numeric rating scales

  measured 30 days postoperatively

Other Outcomes (4)

• Hernia-specific quality of life

  measured 30 days postoperatively

• complications, readmittance, and general practitioner visits

  30-days postoperatively

• clinical recurrence

  2 years

Study Arms (2)

sutured closure of the hernia gap

ACTIVE COMPARATOR

The hernia gap is sutured intracorporally

Procedure: The hernia gap is sutured intracorporally

No closure of the hernia gap

NO INTERVENTION

Physiomesh is placed with at least 5 cm overlap of the gap and fixated with double crown technique

Interventions

The hernia gap is sutured intracorporally PROCEDURE

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.

sutured closure of the hernia gap

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (3)

• 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.

  PMID: 21412910 BACKGROUND

• 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.

  PMID: 31971616 DERIVED

• 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.

  PMID: 24947633 DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

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

Study Officials

• Mette Christoffersen, M.D.

  Individual Purchaser

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 14, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: February 1, 2019
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)