Page 30 - Prevention and Treatment of Incisional Hernia- New Techniques and Materials

Chapter 2
study. Patients will be included in the STITCH trial in combination with one other trial (registration trials only), provided that it is possible to organize the informed consent and the follow up in a proper way for the individual patient for both trials.
Registration procedure
Included patient are registrated before surgery in an online data base (designed and managed by HOVON data center, Rotterdam, the Netherlands,) after signed informed consent via the Internet via TOP (Trial Online Process; see www.stitchtrial.nl). The patient namecode, date of birth, name of caller, name of responsible physician, sex and eligible criteria will be registered. Every participating institution has its own login code.
Randomisation procedure
The randomization process is started only 15 minutes before closure to prevent consequences due to the trial during the operation with the online TOP randomisation.
Patients will be randomized between closure with the large tissue bites technique or with the small tissue bites technique. Randomisation is strati ed by center, and between surgeon or resident with a minimization procedure, ensuring balance within each stratum and overall balance. The randomization result will be given immediately by TOP. A con rmation email without randomization result will be send to the investigator.
Patients will be kept unaware of the type of closure until the endpoint of the trial. Surgeons or residents blinded for the procedure will perform outpatient clinic controls. Postoperative ultrasonography will be performed by radiologists blinded for type of closure. The randomisation procedure, blinding and objecti cation of incisional hernia by ultrasound will provide the best possible data to support preference for the large bites technique or the small bites technique over the other for closure of the abdominal wall.
Interventions
In this trial the large bites technique will be compared with the small tissue bites technique as developed in Sundsvall Hospital, Sweden(18). In the rst group, the conventional large bites technique will be applied with bite widths of 1 cm and intersuture spacing of 1 cm with the use of one PDS plus II loop with a 48
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