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

NCT ID: NCT01962480

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2019-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

sutured closure of the hernia gap

The hernia gap is sutured intracorporally

Group Type: ACTIVE_COMPARATOR

The hernia gap is sutured intracorporally

Intervention Type: 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.

No closure of the hernia gap

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mette Willaume Christoffersen

M.D, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mette Christoffersen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Individual Purchaser

Locations

Hvidovre University Hospital

Hvidovre, , Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 21412910 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31971616 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24947633 (View on PubMed)

Other Identifiers

CLOSE-GAP-1

Identifier Type: -

Identifier Source: org_study_id