Endoscopic eTEP Versus Open Rives-Stoppa

Completed

• Conditions: Rectus Diastasis; Hernia, Ventral
• Interventions: Procedure: Open Rives-Stoppa; Procedure: Endoscopic eTEP

• 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

Arm && Interventions

Group	Intervention	Description
Rives-Stoppa, control	Open Rives-Stoppa	Thirty participants will be selected out of all patients who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center and who do not meet any of the exclusion criteria. Participant selection will consist of matching to participants in group 1 according to gender and age (e.g. a male participant in group 1 will be matched to a male participant (group 2) out of the investigators' records who underwent an open Rives-Stoppa repair and whose age most closely resembles the age of the matched participant in group 1).
eTEP	Endoscopic eTEP	First 30 participants who meet the inclusion criteria and do not exhibit any of the exclusion criteria will be investigated. The option for endoscopic eTEP repair, if feasible, is given preoperatively as a standard for the treatment of symptomatic midline abdominal wall hernias with concomitant rectus abdominis diastasis as an alternative to open Rives-Stoppa mesh repair. The modality of operative treatment is made in cooperation with the participant.

Primary Outcome Measures

Name	Time	Method
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
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

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