Endoscopic eTEP Versus Open Rives-Stoppa

February 21, 2024 updated by: AZ Alma

Single-Center Observational Study With Comparison of Endoscopic Extended-View Totally Extraperitoneal Prosthesis (eTEP) Versus Open Rives-Stoppa Repair as a Treatment of Midline Abdominal Wall Hernias With Rectus Diastasis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Eeklo, Oost-Vlaanderen, Belgium, 9900
        • AZ Alma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Endoscopic extended view totally extraperitoneal prosthesis repair.
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
Open Rives-Stoppa repair with retromuscular mesh placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: From the date of operation until the date of discharge from the hospital, assessed up to 30 days.
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
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative complications
Time Frame: During surgery
Adverse event occurrence
During surgery
Postoperative complications
Time Frame: After discharge until 30 days postoperative
Adverse event occurrence by readmission
After discharge until 30 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Alma

Investigators

  • Principal Investigator: Sam Kinet, MD, AZ Alma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2022

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

December 23, 2022

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/EH/220608-SK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol will be sent to journal at time of application for publication after completion.

IPD will be shared via the online EHS registry with contents adhering to their format. Accessible to all EHS members for all types of analyses.

IPD Sharing Time Frame

At completion of the study.

IPD Sharing Access Criteria

EHS-membership.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: EC/EH/220608-SK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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