CLOSE-GAP
The Clinical Effects of Intracorporally Closure of the Hernia Defect in Laparoscopic Umbilical or Epigastric Hernia Repair
Sponsor study identifier
interventional
80
1 country
1
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2016
Actual (reported)Study Completion
February 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2013
Actual (reported)October 14, 2013
Actual (reported)November 2013
Date type not reportedThis date has not been verified as actual or estimated.
August 2016
Actual (reported)February 2019
Actual (reported)Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale
24 hrs postoperatively
Cosmetic result measured with verbal rating scale and numeric rating scales
measured 30 days postoperatively
Hernia-specific quality of life
measured 30 days postoperatively
complications, readmittance, and general practitioner visits
30-days postoperatively
clinical recurrence
2 years
The hernia gap is sutured intracorporally
Physiomesh is placed with at least 5 cm overlap of the gap and fixated with double crown technique
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hvidovre University Hospital
Hvidovre, 2650, Denmark
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;2011(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.
Mette Christoffersen, M.D.
Individual Purchaser
80 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2013
First Posted
October 14, 2013
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
3 Fixation Devices in Laparoscopic Ventral Herniotomy
Contact the study team to confirm eligibility.
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.
Primary Completion
August 2016
Actual (reported)Study Completion
February 2019
Actual (reported)Last Updated
February 22, 2019
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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