The Clinical Effects of Intracorporally Closure of the Hernia Defect in Laparoscopic Umbilical or Epigastric Hernia Repair
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
sutured closure of the hernia gap
The hernia gap is sutured intracorporally
Intervention: The hernia gap is sutured intracorporally (Procedure)
No closure of the hernia gap
Physiomesh is placed with at least 5 cm overlap of the gap and fixated with double crown technique
Outcomes
Primary Outcomes
Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale
Time Frame: 24 hrs postoperatively
Secondary Outcomes
- Cosmetic result measured with verbal rating scale and numeric rating scales(measured 30 days postoperatively)
Investigators
Mette Willaume Christoffersen
M.D, PhD
Hvidovre University Hospital