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

Hvidovre University Hospital

Status

Completed

Conditions

Ventral Hernias

Treatments

Procedure: The hernia gap is sutured intracorporally

Study type

Interventional

Funder types

Other

Identifiers

NCT01962480

CLOSE-GAP-1

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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