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Mesh fixation during intraperitoneal onlay mesh (IPOM) using either spiral tacks or vicryl sutures - a randomised clinical trial

Mesh fixation during intraperitoneal onlay mesh (IPOM) using either spiral tacks or vicryl sutures - a randomised clinical trial - IPOM mesh fixation trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005743
Enrollment
80
Registered
2014-05-21
Start date
2014-05-21
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

K42 K43

Interventions

Group 1: Mesh fixation with single vicryl sutures Group 2: Mesh fixation with spiral tacks (AbsorbaTack™
Covidien Germany GmbH, Neustadt / Donau)

Sponsors

Helios St.Elisabeth Klinik Oberhausen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Indication for elective surgery due to an abdominal wall hernia (umbilical, epigastric or incisional); age =18 years and legal competence

Exclusion criteria

Exclusion criteria: Previous surgery at same site with IPOM mesh; pregnancy; planned additional surgeries; emergency surgery; chronic conditions requiring permanent analgesics; neuromuscular diseases interfering with pain perception; severe comorbidity with <75% survival probability after one year; lack of informed consent

Design outcomes

Primary

MeasureTime frame
Pain intensity at coughing on postoperative day 1 to 3 In total, 6 NRS values will be collected (a.m. and p.m.) and summed up for analysis.

Secondary

MeasureTime frame
Duration of surgery; complications / adverse events; analgesic consumption; reoperation rate; length of hospital stay; return to normal activities; disease-specific quality of life (Carolinas Comfort Scale)

Countries

Germany

Contacts

Public ContactMike Ralf Langenbach

Helios St.Elisabeth Klinik Oberhausen

ob-allgemeinchirurgie@helios-kliniken.de0208-85064001

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026