Open Access Study protocol

A multicenter randomized controlled trial evaluating the effect of small stitches on the incidence of incisional hernia in midline incisions

Joris J Harlaar1*, Eva B Deerenberg1, Gabrielle H van Ramshorst1, Harold E Lont2, Ed CMH van der Borst3, Willem R Schouten1, Joos Heisterkamp3, Helena C van Doorn4, Huib A Cense5, Frits Berends6, Hein BAC Stockmann7, Wietske W Vrijland8, Esther CJ Consten9, Reyer T Ottow10, Peter MNYH Go11, John J Hermans12, Ewout W Steyerberg13 and Johan F Lange1

Author Affiliations

1 Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands

2 Department of Surgery, Vlietland Ziekenhuis, Schiedam, The Netherlands

3 Department of Surgery, St. Elisabeth Ziekenhuis, Tilburg, The Netherlands

4 Department of Gynaecology, Erasmus MC, Rotterdam, The Netherlands

5 Department of Surgery, Rode Kruis Ziekenhuis, Beverwijk, The Netherlands

6 Department of Surgery, Rijnstate Ziekenhuis, Arnhem, The Netherlands

7 Department of Surgery, Kennemer Gasthuis, Haarlem, The Netherlands

8 Department of Surgery, Sint Franciscus Gasthuis, Rotterdam, The Netherlands

9 Department of Surgery, Meander MC, Amersfoort, The Netherlands

10 Department of Surgery, Groene Hart Ziekenhuis Gouda, The Netherlands

11 Department of Surgery, Antonius Ziekenhuis Nieuwegein, The Netherlands

12 Department of Radiology, Erasmus MC, Rotterdam, The Netherlands

13 Department of Public Health, Erasmus MC, Rotterdam, The Netherlands

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BMC Surgery 2011, 11:20  doi:10.1186/1471-2482-11-20

Published: 26 August 2011

Abstract

Background

The median laparotomy is frequently used by abdominal surgeons to gain rapid and wide access to the abdominal cavity with minimal damage to nerves, vascular structures and muscles of the abdominal wall. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Recent clinical and experimental data showed a continuous suture technique with many small tissue bites in the aponeurosis only, is possibly more effective in the prevention of incisional hernia when compared to the common used large bite technique or mass closure.

Methods/Design

The STITCH trial is a double-blinded multicenter randomized controlled trial designed to compare a standardized large bite technique with a standardized small bites technique. The main objective is to compare both suture techniques for incidence of incisional hernia after one year. Secondary outcomes will include postoperative complications, direct costs, indirect costs and quality of life.

A total of 576 patients will be randomized between a standardized small bites or large bites technique. At least 10 departments of general surgery and two departments of oncological gynaecology will participate in this trial. Both techniques have a standardized amount of stitches per cm wound length and suture length wound length ratio's are calculated in each patient. Follow up will be at 1 month for wound infection and 1 year for incisional hernia. Ultrasound examinations will be performed at both time points to measure the distance between the rectus muscles (at 3 points) and to objectify presence or absence of incisional hernia. Patients, investigators and radiologists will be blinded during follow up, although the surgeon can not be blinded during the surgical procedure.

Conclusion

The STITCH trial will provide level 1b evidence to support the preference for either a continuous suture technique with many small tissue bites in the aponeurosis only or for the commonly used large bites technique.

Trial registration

Clinicaltrials.gov NCT01132209