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Open Access Study protocol

The INCH-Trial: a multicentre randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional hernia repair

Marijn Poelman12*, Jan Apers3, Han van den Brand2, Huib Cense4, Esther Consten5, Jort Deelder2, Boudewijn Dwars6, Nanette van Geloven7, Elly de Lange1, Johan Lange8, Rogier Simmermacher9, Maarten Simons10, Eric Sonneveld11, Hermien Schreurs2 and Jaap Bonjer1

Author Affiliations

1 VU University Medical Centre, Amsterdam, Netherlands

2 Alkmaar Medical Centre, Alkmaar, Netherlands

3 Leeuwarden Medical Centre, Leeuwarden, Netherlands

4 Red Cross Hospital, Beverwijk, Netherlands

5 Meander Medical Centre, Amersfoort, Netherlands

6 Slotervaart Hospital, Amsterdam, Netherlands

7 Tergooi Hospital, Hilversum, Netherlands

8 Erasmus Unversoty Medical Centre, Rotterdam, Netherlands

9 Utrecht University Medical Centre, Utrecht, Netherlands

10 OLVG Hospital, Amsterdam, Netherlands

11 Westfries Gasthuis Hospital, Hoorn, Netherlands

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BMC Surgery 2013, 13:18  doi:10.1186/1471-2482-13-18

Published: 7 June 2013

Abstract

Background

Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. About 15,000 of these patients will develop an incisional hernia. Both open and laparoscopic surgical repair have been proven to be safe. However, the most effective treatment of incisional hernias remains unclear. This study, the ‘INCH-trial’, comparing cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed.

Methods/Design

A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias. Patients with a symptomatic incisional hernia, eligible for laparoscopic and open incisional hernia repair. Only surgeons, experienced in both open and laparoscopic incisional hernia repair, will participate in the INCH trial. During incisional hernia repair, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm. Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, recurrences, mortality and quality of life.

Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair. A difference of two days is considered significant. One-hunderd-and-thirty-five patients are enrolled in each treatment arm. The economic evaluation will be performed from a societal perspective. Primary outcomes are costs per patient related to time-to-recovery and quality of life.

The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to conventional open incisional hernia repair in terms of cost-effectiveness. This is measured through length of hospital stay and quality of life. Secondary endpoints are re-operation rate due to post-operative complications or recurrences, mortality and quality of life.

Discussion

The difference in time to full recovery between the two treatment strategies is thought to be in favor of laparoscopic incisional hernia repair. Laparoscopic incisional hernia repair is therefore expected to be a more cost-effective approach.

Trial registration

Netherlands Trial register: NTR2808