Endoscopic eTEP Versus Open Rives-Stoppa

NCT05446675 | Completed

• 1 other identifier: EC/EH/220608-SK
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Hernia, Ventral; Rectus Diastasis

Keywords

eTEP; Retromuscular; Minimally invasive; Endoscopic; Hernia; Rectus diastasis; Rives-Stoppa

Outcome Measures

Primary Outcomes (2)

• Length of hospital stay

  Time (days) spent within the hospital

  From the date of operation until the date of discharge from the hospital, assessed up to 30 days.

• Postoperative pain management

  Modality (type, generic name), duration (days), dosage (grams or milligrams) and frequency (times per day) of analgesics administration

  From the end of surgery (moment of the end of operation) until the date of discharge from the hospital, assessed up to 30 days.

Secondary Outcomes (2)

• Intraoperative complications

  During surgery

• Postoperative complications

  After discharge until 30 days postoperative

Study Arms (2)

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.

Procedure: Endoscopic eTEP

Rives-Stoppa, control

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).

Procedure: Open Rives-Stoppa

Interventions

Endoscopic eTEP PROCEDURE

Endoscopic extended view totally extraperitoneal prosthesis repair.

eTEP

Open Rives-Stoppa PROCEDURE

Open Rives-Stoppa repair with retromuscular mesh placement.

Rives-Stoppa, control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who underwent repair for their midline abdominal wall hernias alongside rectus abdominis diastasis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Alma: lead

Study Sites (1)

AZ Alma

Eeklo, Oost-Vlaanderen, 9900, Belgium

Location

Related Publications (1)

• Kinet S, Maes H, Van Cleven S, Brusselaers N, Kuppens EFP. Endoscopic enhanced-view totally extraperitoneal prosthetic (eTEP) versus open Rives-Stoppa repair as a treatment of midline abdominal wall hernias with rectus diastasis: comparison of postoperative pain and length of hospital stay in a single-centre surgical cohort. Updates Surg. 2024 Dec;76(8):2923-2931. doi: 10.1007/s13304-024-01905-4. Epub 2024 Jun 23.

  PMID: 38909352 DERIVED

MeSH Terms

Conditions

Hernia, Ventral; Hernia

Condition Hierarchy (Ancestors)

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

Study Officials

• Sam Kinet, MD

  AZ Alma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 7, 2022
• Study Start: June 9, 2022
• Primary Completion: August 30, 2022
• Study Completion: December 23, 2022
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: At completion of the study.
• Access Criteria: EHS-membership.

Locations

BE (1)