Hernia reduction following laparotomy using small stitch abdominal wall closure with or without mesh augmentatio

Not Applicable

Recruiting

Conditions: Scheduled elective abdominal operation via a midline laparotomy

Registration Number: DRKS00017517

Lead Sponsor: niversitätsklinikum Ulm

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 812

Inclusion Criteria

1. Elective abdominal operation via a midline laparotomy
2. Planned clean or clean-contaminated operations according to the Centre for Disease Control (CDC) definition
3. Patient age at least 18 years
4. Ability to understand the nature and extent of the trial and to give written informed consent.
5. Written informed consent
6. Life expectancy at least 2 years

Exclusion Criteria

1. American Society of Anaesthesiologists (ASA) grade > 3
2. Pregnant or lactating woman
3. Midline laparotomy within the last 60 days prior to trial intervention
4. Previous incisional abdominal hernia or fascial dehiscence
5. Planned relaparotomy via the midline incision within 2 years after trial intervention
6. Concurrent abdominal wall infections
7. Participation in another intervention-trial with interference of intervention and/or outcome of this study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incisional hernia rate within 24 months after intervention as defined by the European Hernia Society

Secondary Outcome Measures

Name	Time	Method
1. Rate of superficial and deep surgical site infections according to Centers for Disease Control (CDC) criteria within one year in both groups;<br>2. Postoperative (30 day) morbidity according to the Dindo-Clavien classification; <br>3. Rate of non-infectious wound complications (hematoma, seroma) within 30 days after index Operation;<br>4. Rate of postoperative burst abdomen defined as missing continuity of the fascia in combination with wound dehiscence with consecutive reoperation within 30 days after index oeration;<br>5. Postoperative wound pain according to the numeric rating scale on postoperative days 5-7 and 30-35;<br>6. Quality of life measured with the SF-36 and EQ-5D questionnaires at baseline and at postoperative months 6, 12, and 24;<br>7. Length of postoperative hospital stay after index operation