The role of abdominal wall closure with continuous suture in combination with interrupted retention sutures of the abdominal wall fascia after median emergency laparotomy.
- Conditions
- K43.9T81.3Other and unspecified ventral hernia without obstruction or gangreneDisruption of operation wound, not elsewhere classified
- Registration Number
- DRKS00024802
- Lead Sponsor
- Klinik für Allgemein-, Viszeral- und Transplantationschirurgie; Universitätsklinikum Augsburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 222
Patients undergoing primary emergency surgery for acute disease of the abdominal visceral organs via median laparotomy. Patients must be at least 18 years of age with a survival expectancy of at least 12 months.
Each patient enrolled in the study must be capable of consent, not cared for and must provide written informed consent.
Due to the emergency situation, the informed consent will be given shortly before visceral surgery.
Patients who are incapable of giving consent, underage patients, pregnant patients and patients with immune system impairment, severe psychiatric illness and lack of compliance will be excluded from the study.
To the additional exclusion criteria belong lack of understanding (linguistic or cognitive) of study instructions, chemotherapy or radiotherapy up to 2 months prior to surgery, and a pre-existing median laparotomy scar (except condition after laparoscopic surgery, Cholecystectomy, Hysterectomy and Sectio, transverse laparotomy).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of postoperative fascial dehiscence, either as a burst abdomen within the first 30 postoperative days or as an incisional hernia within the first 12 months after surgery.
- Secondary Outcome Measures
Name Time Method - Rate of wound infections 30 days after surgery<br>- Frequency of reoperations<br>- Quality of life (SF-36 v1.0 questionnaire)<br>- Duration of wound healing / chronic wounds (Wound-QoL questionnaire)<br>- Pain in the area of the postoperative scar<br>- Rate of suture granulomas<br>- Duration of postoperative inpatient stay<br>- Duration of stay in intensive care unit<br>- Postoperative complications (according to Clavien-Dindo)<br>- Lethality<br>- Length of skin incision<br>- Length of fascia incision (corresponding to skin incision)<br>- Duration of vacuum therapy<br>- Duration until first defecation<br>- Postoperative pulmonary infections<br>- Duration of mechanical ventilation and hemodialysis