Laparoscopic IPOM Plus vs. eTEP Trial
NCT05528107 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2023-03-16
Summary
The survey will compare primary and secondary outcomes of laparoscopic intraperitoneal onlay mesh (IPOM plus) and extended totally extraperitoneal (eTEP) repair for incisional hernia.
The research hypothesis is the following: patients who underwent eTEP repair may experience 30% less pain, assessed on the NRS-11 scale by the end of postoperative day 1, compared with IPOM plus procedure
Conditions
- Incisional Hernia of Midline of Abdomen
Interventions
- PROCEDURE
-
Lap IPOM plus
Participants will undergo Lap IPOM plus repair according to the assigned treatment arm.
- PROCEDURE
-
eTEP
Participants will undergo eTEP repair according to the assigned treatment arm.
Sponsors & Collaborators
-
Pirogov Russian National Research Medical University
collaborator OTHER -
City Clinical Hospital No.1 named after N.I. Pirogov
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-14
- Primary Completion
- 2023-12-31
- Completion
- 2024-03-31
Countries
- Russia
Study Locations
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