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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sutured closure of the hernia gap | Active Comparator | The hernia gap is sutured intracorporally |
|
| No closure of the hernia gap | No Intervention | Physiomesh is placed with at least 5 cm overlap of the gap and fixated with double crown technique |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale | 24 hrs postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic result measured with verbal rating scale and numeric rating scales | measured 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Hernia-specific quality of life | Measured with Carolina Comfort Scale (CCS) | measured 30 days postoperatively |
| complications, readmittance, and general practitioner visits | Measured with patient interview, and/or patient files |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mette Christoffersen, M.D. | Individual Purchaser | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21412910 | Background | 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. | |
| 31971616 | Derived | Christoffersen MW, Westen M, Rosenberg J, Helgstrand F, Bisgaard T. Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial. Br J Surg. 2020 Feb;107(3):200-208. doi: 10.1002/bjs.11490. |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 30-days postoperatively |
| clinical recurrence | clinical or radiological recurrence | 2 years |
| chronic pain | moderate or severe chronic pain after 2 years | within 2 years |
| 24947633 | Derived | Christoffersen MW, Westen M, Assadzadeh S, Deigaard SL, Rosenberg J, Bisgaard T. The clinical effects of closure of the hernia gap after laparoscopic ventral hernia repair: protocol for a randomised controlled trial. Dan Med J. 2014 Jun;61(6):A4865. |