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

Not Applicable

• Conditions: K42; K43; Umbilical hernia; Ventral hernia

• Registration Number: DRKS00005743
• Lead Sponsor: Helios St.Elisabeth Klinik Oberhausen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-21
• Study Completion: 2018-12-31
• Results First Posted: 2019-06-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity at coughing on postoperative day 1 to 3<br>In total, 6 NRS values will be collected (a.m. and p.m.) and summed up for analysis.

Secondary Outcome Measures

Name	Time	Method
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)