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

Ventral Hernias Clinical Trial

— CLOSE-GAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962480
• Other study ID #: CLOSE-GAP-1
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: February 2019

Study information

• Verified date: February 2019
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2019
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernias

Intervention

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.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hernia-specific quality of life	Measured with Carolina Comfort Scale (CCS)	measured 30 days postoperatively
Other	complications, readmittance, and general practitioner visits	Measured with patient interview, and/or patient files	30-days postoperatively
Other	clinical recurrence	clinical or radiological recurrence	2 years
Other	chronic pain	moderate or severe chronic pain after 2 years	within 2 years
Primary	Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale		24 hrs postoperatively
Secondary	Cosmetic result measured with verbal rating scale and numeric rating scales		measured 30 days postoperatively