Endoscopic eTEP Versus Open Rives-Stoppa

Hernia, Ventral Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446675
• Other study ID #: EC/EH/220608-SK
• Status: Completed
• Start date: June 9, 2022
• Est. completion date: December 23, 2022

Study information

• Verified date: February 2024
• Source: AZ Alma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 23, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diastasis, Muscle
• Hernia
• Hernia, Ventral
• Rectus Diastasis

Intervention

Procedure:
• Endoscopic eTEP
Endoscopic extended view totally extraperitoneal prosthesis repair.
• Open Rives-Stoppa
Open Rives-Stoppa repair with retromuscular mesh placement.

Locations

Country	Name	City	State
Belgium	AZ Alma	Eeklo	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
AZ Alma

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Intraoperative complications	Adverse event occurrence	During surgery
Secondary	Postoperative complications	Adverse event occurrence by readmission	After discharge until 30 days postoperative