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Completed

NCT Number: NCT05446675

Endoscopic eTEP Versus Open Rives-Stoppa

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).

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Key information

Conditions

HERNIA, VENTRAL Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectus Diastasis

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Alma

Eeklo, Oost-Vlaanderen, 9900, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic eTEP

Procedure

Endoscopic extended view totally extraperitoneal prosthesis repair.

Open Rives-Stoppa

Procedure

Open Rives-Stoppa repair with retromuscular mesh placement.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Intraoperative complications

    Time frame: During surgery

    Adverse event occurrence

  2. Postoperative complications

    Time frame: After discharge until 30 days postoperative

    Adverse event occurrence by readmission

Sponsors and collaborators

Lead sponsor

AZ Alma

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2022
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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