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OpenTrials
Completed

NCT Number: NCT01719718

The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair

A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Algemeen Stedelijk Ziekenhuis, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent from the patient or his/her legal representative
  • Ventral or incisional hernia requiring elective surgical repair
  • Diameter between 2 and 5cm in width
  • Midline and flank hernias are eligible

Exclusion criteria

  • No written informed consent
  • 'Hostile' abdomen, open abdomen treatment
  • Contraindication to pneumoperitoneum
  • Emergency surgery (incarcerated hernia)
  • Parastomal hernia
  • Subxiphoidal hernia
  • Subcostal hernia
  • Suprapubic hernia
  • Clean-contaminated or contaminated field
  • Hernia diameter >5cm in width
  • Pregnancy
  • Non-compliance

Treatment and study plan

Closure of hernia defect.

Procedure

Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).

No closure of the hernia defect.

Procedure

Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).

Primary outcomes

  1. Seroma formation after 4 weeks.

    Time frame: 4 weeks after surgery.

    The seroma formation is checked by clinical evaluation.

Secondary outcomes

  1. Pain, discomfort and esthetic evaluation after 4 weeks.

    Time frame: 4 weeks after surgery.

    Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.

  2. Pain, discomfort and esthetic evaluation after 1 year.

    Time frame: 1 year after surgery.

    Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.

  3. Pain, discomfort and esthetic evaluation after 2 years.

    Time frame: 2 years after surgery.

    Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair.

Acronym: CLOSURE

Important dates

Study start
2012
Primary completion
2015
Study completion
2023
First posted
Nov 1, 2012
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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