Trials / Unknown
UnknownNCT06251583
Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site.
Prevention of Incisional Hernia With Mesh-suture (Duramesh Suture) at Umbilical Trocar Site in Patients Who Undergo Laparoscopic Surgical Approach
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- Sponsor
- Miguel A ngel Garci-a Urena · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs. The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias. INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | duramesh suture | Duramesh-suture will be used for trocar closure in the experimental group |
Timeline
- Start date
- 2023-03-22
- Primary completion
- 2024-03-22
- Completion
- 2025-06-30
- First posted
- 2024-02-09
- Last updated
- 2024-02-09
Locations
1 site across 1 country: Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06251583. Inclusion in this directory is not an endorsement.