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

Primary Purpose

Ventral Hernias

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

The hernia gap is sutured intracorporally

About this trial

This is an interventional treatment trial for Ventral Hernias

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

sutured closure of the hernia gap

No closure of the hernia gap

Arm Description

The hernia gap is sutured intracorporally

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cosmetic result measured with verbal rating scale and numeric rating scales

Full Information

NCT ID

NCT01962480

First Posted

October 7, 2013

Last Updated

February 21, 2019

Sponsor

Hvidovre University Hospital

Collaborators

University of Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT01962480

Brief Title

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

Acronym

CLOSE-GAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

Collaborators

University of Copenhagen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventral Hernias

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sutured closure of the hernia gap

Arm Type

Active Comparator

Arm Description

The hernia gap is sutured intracorporally

Arm Title

No closure of the hernia gap

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

The hernia gap is sutured intracorporally

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

24 hrs postoperatively

Secondary Outcome Measure Information:

Title

Cosmetic result measured with verbal rating scale and numeric rating scales

Time Frame

measured 30 days postoperatively

Other Pre-specified Outcome Measures:

Title

Hernia-specific quality of life

Description

Measured with Carolina Comfort Scale (CCS)

Time Frame

measured 30 days postoperatively

Title

complications, readmittance, and general practitioner visits

Description

Measured with patient interview, and/or patient files

Time Frame

30-days postoperatively

Title

clinical recurrence

Description

clinical or radiological recurrence

Time Frame

2 years

Title

chronic pain

Description

moderate or severe chronic pain after 2 years

Time Frame

within 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mette Christoffersen, M.D.

Organizational Affiliation

Individual Purchaser

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hvidovre University Hospital

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21412910

Citation

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.

Results Reference

background

PubMed Identifier

31971616

Citation

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.

Results Reference

derived

PubMed Identifier

24947633

Citation

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.

Results Reference

derived

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

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