Ventral Hernias
Conditions
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.
Interventions
PROCEDUREThe 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.
Sponsors
University of Copenhagen
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale | 24 hrs postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Cosmetic result measured with verbal rating scale and numeric rating scales | measured 30 days postoperatively |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hernia-specific quality of life | measured 30 days postoperatively | Measured with Carolina Comfort Scale (CCS) |
| complications, readmittance, and general practitioner visits | 30-days postoperatively | Measured with patient interview, and/or patient files |
| clinical recurrence | 2 years | clinical or radiological recurrence |
| chronic pain | within 2 years | moderate or severe chronic pain after 2 years |
Countries
Denmark
Outcome results
None listed