Endoscopic eTEP Versus Open Rives-Stoppa

Study Overview
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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.

Official Title
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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

Conditions
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Hernia, Ventral, Rectus Diastasis

Intervention / Treatment
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* Procedure: Endoscopic eTEP
* Procedure: Open Rives-Stoppa


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| eTEP<br>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<br>* Endoscopic extended view totally extraperitoneal prosthesis repair.<br>|
| Rives-Stoppa, control<br>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<br>* Open Rives-Stoppa repair with retromuscular mesh placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eTEP, Retromuscular, Minimally invasive, Endoscopic, Hernia, Rectus diastasis, Rives-Stoppa