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NCT Number: NCT01962480

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

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.

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Key information

Conditions

Ventral Hernias Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The hernia gap is sutured intracorporally

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.

Primary outcomes

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

    Time frame: 24 hrs postoperatively

Secondary outcomes

  1. Cosmetic result measured with verbal rating scale and numeric rating scales

    Time frame: measured 30 days postoperatively

Other outcomes

  1. Hernia-specific quality of life

    Time frame: measured 30 days postoperatively

    Measured with Carolina Comfort Scale (CCS)

  2. complications, readmittance, and general practitioner visits

    Time frame: 30-days postoperatively

    Measured with patient interview, and/or patient files

  3. clinical recurrence

    Time frame: 2 years

    clinical or radiological recurrence

  4. chronic pain

    Time frame: within 2 years

    moderate or severe chronic pain after 2 years

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Acronym: CLOSE-GAP

Important dates

Study start
2013
Primary completion
2016
Study completion
2019
First posted
Oct 14, 2013
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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