Abstract
BackgroundThe 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/DesignThe 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.ConclusionThe 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 registrationClinicaltrials.gov NCT01132209
Highlights
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
For prevention of incisional hernia, many clinical trials and meta-analyses have demonstrated that a mass closure technique with a simple running suture is the best option to close a midline incision
The use of slowly resorbable suture material compared with non-resorbable suture material decreases the incidence of incisional hernia, and it lowers the incidence and intensity of postoperative pain and wound infection [12,15,16]
Summary
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. 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. Suture length to wound length ratio and small bites Several authors have stated that a suture length to wound length ratio (SL:WL) of four or more must be achieved, since a lower ratio is associated with an increased rate of incisional hernia [7,17,18,19,20]. Long stitches have been associated with high rates of both wound infection and incisional hernia [17,29,30]. A long stitch length may be associated with higher risks of wound infection due to an increase in the amount of necrotic tissue within the wound. The risk of incisional hernia may be higher because the stitch tends to slacken, which allows wound edges to separate
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