Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure (NCT01965249) | Clinical Trial Compass
CompletedNot Applicable
Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure
Austria, Germany425 participantsStarted 2014-02
Plain-language summary
The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia. Several suture technique and suture material have been used but the incidence of this complication still lies between 9 -20%. Synthetic suture material which have become available over the last decades have the advantage that they are degraded by the body system and fully absorbed within 70-180 days; however they loss 50% of their initial strength already after 14-30 days and may not be the optimal suture material for abdominal wall closure. A new suture material (Monomax®) was developed with an extra-long absorption profile, high elasticity and with a superior initial strength. Therefore, the ESTOIH-Study was designed to investigate the influence of the stitch length on the occurrence of incisional hernia using the extra-long term absorbable, elastic, monofilament suture (Monomax®).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Patients undergoing an elective, primary median laparotomy with an incision length of ≥ 15 cm
* Expected survival time longer than 1 year
* ASA I-III
* Written informed consent
Exclusion Criteria:
* Emergency surgery
* Patient undergoing surgery due to a pancreas carcinoma
* Patients who will be operated due to an abdominal aortic aneurysm
* Peritonitis
* Coagulopathy
* Current immunosuppressive therapy (more than 40 mg of a corticoid per day or azathioprin)
* Chemotherapy within the last 2 weeks before operation
* Radiotherapy of the abdomen within the last 6 weeks before operation
* Pregnant women (pregnancy test has to be performed)
* Severe neurologic and psychiatric disease
* Lack of compliance
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared different stitch techniques for closing the abdominal wall — can you explain which specific technique was used in the study and whether you would use that same approach in my surgery?
2Since this trial has already been completed and was measuring incisional hernia rates, have the results been published, and what do they suggest about which closure method leads to fewer hernias?
3Incisional hernias can be a serious complication after abdominal surgery — based on what this trial found, how would you decide which stitch technique is safest for my particular situation?
4This study focused on abdominal wall closure after injury — does my specific condition or type of surgery put me at higher or lower risk for an incisional hernia, and how does that affect which technique you'd recommend for me?
5Are there other factors in my health history, like my weight, age, or any medications I take, that might affect my risk of developing an incisional hernia regardless of which closure technique is used?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.