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

Hernia reduction following laparotomy using small stitch abdominal wall closure with or without mesh augmentation - HULC

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017517

Enrollment

812

Registered

2019-06-24

Start date

2019-08-12

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scheduled elective abdominal operation via a midline laparotomy

Interventions

Group 1: Closure of the midline incision with a slowly absorbable monofilament suture in small stitches technique and additional onlay mesh augmentation using a polypropylene mesh Group 2: Closure of

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Incisional hernia rate within 24 months after intervention as defined by the European Hernia Society	—

Secondary

Measure	Time frame
1. Rate of superficial and deep surgical site infections according to Centers for Disease Control (CDC) criteria within one year in both groups; 2. Postoperative (30 day) morbidity according to the Dindo-Clavien classification; 3. Rate of non-infectious wound complications (hematoma, seroma) within 30 days after index Operation; 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; 5. Postoperative wound pain according to the numeric rating scale on postoperative days 5-7 and 30-35; 6. Quality of life measured with the SF-36 and EQ-5D questionnaires at baseline and at postoperative months 6, 12, and 24; 7. Length of postoperative hospital stay after index operation	—

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactAndré L. Mihaljevic

Klinik für Allgemein- und Viszeralchirurgie

andre.mihaljevic@uniklinik-ulm.de0731-50053502

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026