Endoscopic eTEP Versus Open Rives-Stoppa

NCT ID: NCT05446675

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-09

Study Completion Date

2022-12-23

Brief Summary

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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

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

Conditions

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Hernia, Ventral Rectus Diastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Endoscopic eTEP

Intervention Type PROCEDURE

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).

Open Rives-Stoppa

Intervention Type PROCEDURE

Open Rives-Stoppa repair with retromuscular mesh placement.

Interventions

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Endoscopic eTEP

Endoscopic extended view totally extraperitoneal prosthesis repair.

Intervention Type PROCEDURE

Open Rives-Stoppa

Open Rives-Stoppa repair with retromuscular mesh placement.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Alma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sam Kinet, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Alma

Locations

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AZ Alma

Eeklo, Oost-Vlaanderen, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 38909352 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Study Documents

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Document Type: Individual Participant Data Set

View Document

Other Identifiers

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EC/EH/220608-SK

Identifier Type: -

Identifier Source: org_study_id

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