Page 29 - Prevention and Treatment of Incisional Hernia- New Techniques and Materials

endpoints include postoperative complications, in particular surgical site infection, burst abdomen and wound pain in the rst postoperative month.
Methods
Trial Design
The STITCH trial has been designed as a prospective, multicenter, double- blind, randomized controlled trial, in which the large bites technique will be compared with the small bites technique.
Participants
Patients scheduled for an elective abdominal operation through a midline incision will be asked for informed consent at the outpatient clinic or in hospital on the day preceding the day of surgery. Also, emergency laparotomies can be included in this trial if the patient is able to sign the informed consent. We intend to investigate the e cacy of the small bites technique in all risk groups. This also includes oncological gynaecological patients in centers with at least 50 median laparotomies a year.
Inclusion criteria:
• Signed informed consent
• Laparotomy through a midline incision
• Age 18 years or older
Exclusion criteria:
• Previous incisional hernia or fascial dehiscence with secondary healing after a midline incision
• Abdominal surgery through a midline incision within the last three months
• Pregnancy
Since the STITCH trial is an intervention study, it is not considered desirable to combine this trial with other intervention studies. In case of non-intervention (registration) studies, it will be judged on individual basis whether it is suitable and ethically correct to include a patient in both the STITCH trial and in another
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STITCH protocol
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