Endoscopic eTEP Versus Open Rives-Stoppa

Completed

• Conditions: Rectus Diastasis; Hernia, Ventral

• Registration Number: NCT05446675
• Lead Sponsor: AZ Alma

Brief Summary

Observational cohort study (partially retrospective, partially prospective) comparing the endoscopic extended totally extraperitoneal prosthesis (eTEP) repair for midline abdominal hernias to open Rives-Stoppa repair (control).

Detailed Description

See included study protocol. Included patients will be registered to the European Hernia Society (EHS) registry.

Study Timeline

• Study Start: 2022-06-09
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-07
• Primary Completion: 2022-08-30
• Study Completion: 2022-12-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Group 1 (eTEP):

• Participants who underwent an eTEP procedure in the investigators' center
• Preoperative existence of one or more midline abdominal wall hernias
• Preoperative existence of rectus abdominis diastasis

Group 2 (Rives-Stoppa, control group):

• Participants who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center

Exclusion Criteria

Group 1 (eTEP):

• Preoperative absence of midline abdominal wall hernias
• Preoperative absence of rectus abdominis diastasis
• Intraoperative performance of transverse abdominis release (TAR)
• Intraoperative inguinal hernia repair

Group 2 (Rives-Stoppa, control group):

• Intraoperative performance of transverse abdominis release (TAR)
• Intraoperative performance of anterior component separation
• Intraoperative inguinal hernia repair

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	From the date of operation until the date of discharge from the hospital, assessed up to 30 days.	Time (days) spent within the hospital
Postoperative pain management	From the end of surgery (moment of the end of operation) until the date of discharge from the hospital, assessed up to 30 days.	Modality (type, generic name), duration (days), dosage (grams or milligrams) and frequency (times per day) of analgesics administration

Secondary Outcome Measures

Name	Time	Method
Intraoperative complications	During surgery	Adverse event occurrence
Postoperative complications	After discharge until 30 days postoperative	Adverse event occurrence by readmission

Trial Locations

Locations (1)

AZ Alma; 🇧🇪 Eeklo, Oost-Vlaanderen, Belgium