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Endoscopic eTEP Versus Open Rives-Stoppa

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05446675
Enrollment
60
Registered
2022-07-07
Start date
2022-06-09
Completion date
2022-12-23
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Ventral, Rectus Diastasis

Keywords

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

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.

Interventions

PROCEDUREEndoscopic eTEP

Endoscopic extended view totally extraperitoneal prosthesis repair.

PROCEDUREOpen Rives-Stoppa

Open Rives-Stoppa repair with retromuscular mesh placement.

Sponsors

AZ Alma
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stayFrom 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 managementFrom 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

MeasureTime frameDescription
Postoperative complicationsAfter discharge until 30 days postoperativeAdverse event occurrence by readmission
Intraoperative complicationsDuring surgeryAdverse event occurrence

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026