Open vs. Endoscopic Transversus Abdominis Release Trial

Comparison of Open and Endoscopic Transversus Abdominis Release for Midline Incisional Ventral Hernia - a Randomized Controlled Trial

This study aims to comparatively evaluate the early and long-term results of open and endoscopic TAR procedure for large midline incisional ventral hernias.

Study Overview

• Status: Not yet recruiting
• Conditions: Incisional Hernia of Midline of Abdomen
• Intervention / Treatment: Procedure: open TAR; Procedure: endoscopic TAR

Detailed Description

Minimally invasive (endoscopic) transversus abdominis release (TAR) - new technique for the treatment of patients with large incisional ventral hernia. Term "endoscopic" TAR combines two minimally invasive (laparosopic or extraperitoneal (eTEP) approaches. These techniques have demonstrated significant advantages compared with open TAR in several retrospective studies. There are currently no randomized trials comparing open and endoscopic TAR operations for incisional ventral hernia repair.This study aims to comparatively evaluate the early and long-term results of open and endoscopic TAR procedure for large midline incisional ventral hernias.

The sample size was determined based on a previously conducted retrospective pilot study comparing the results of open and endoscopic TAR procedures for midline incisional ventral hernia repair. The retrospective study included 133 patients with midline incisional ventral hernias who were underwent Rives-Stoppa hernia repair in combination with bilateral posterior component separation with transversus abdominis release via open (open TAR) or endoscopic (eTAR) technique in Moscow City Hospital №1 from January 2018 to December 2022. All patients were included in the study, starting from the moment of endoscopic TAR technique was introduced into the clinic. At the same time, the learning curve for the open TAR had already been reached at that time; more than 20 open TAR interventions were performed in the clinic in 2016-2017. The average hospitalization time in open TAR group was 6.7 ± 2.14 days. In endoscopic TAR group the average hospitalization time after surgery was 5.2 ± 1.65 bed days. After achieving the learning curve (20 operations) for the endoscopic TAR procedure technique average hospitalization period after surgery was 4.8 ± 1.47 days. Thus, a decrease in the duration of hospitalization in endoscopic TAR group after reaching the learning curve was noted by 28.4%. This fact, based on a retrospective pilot study, allows the investigators to assume as a hypothesis for this RCT a reduction in the duration of hospitalization during endoscopic TAR by at least 30% as a guideline for calculating the power of the study. Thus, assuming a Type I error probability α of 0.05 and a Type 2 error probability β of 0.20, it would require a total sample size of 36 patients (18 patients in each group).

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Sazhin, professor; Phone Number: +79163904180; Email: sazhin-av@yandex.ru
• Study Contact Backup: Name: Georgy Ivakhov, professor; Phone Number: +79262844224

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Clinical City Hospital #1 named after N.I. Pirogov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• midline incisional hernia
• defect width from 8 till 12 cm
• ASA I-III class
• able to give informed consent
• elective hernia repair
• considered eligible for minimally invasive ventral hernia repair

Exclusion Criteria:

• primary ventral hernia
• lateral hernia with/without midline
• refuse to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: open TAR; Open transversus abdominis release procedure will be use as combine open procedure Rives-Stoppa hernia repair in combination with bilateral transversus abdominis release with retromuscular mesh placement	Procedure: open TAR; Participants will undergo open TAR repair according to the assigned treatment arm.; Other Names: open transversus abdominis release
Active Comparator: endoscopic TAR; Endoscopic transversus abdominis release procedure will be use as combine minimally invasive Rives-Stoppa hernia repair in combination with bilateral transversus abdominis release via endoscopic technique with retromuscular mesh placement	Procedure: endoscopic TAR; Participants will undergo endoscopic TAR repair according to the assigned treatment arm.; Other Names: endoscopic transversus abdominis release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay after surgery	From date of operation until discharge	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of operation	time from beginning to the end of surgery	period of operation
surgical site occurrences rate	incidence of all type of wound complications	30 days after surgery
surgical site infection rate	incidence of wound infection	30 days after surgery
rate of postoperative complications	number of participants with postoperative complications	30 days after surgery
rate of postoperative complications Clavien 3a and higher	number of participants with postoperative complications Clavien 3a and higher, evaluated by Clavien-Dindo classification of surgical complications from Dindo et al.	30 days after surgery
Comprehensive complication index	Comprehensive complication index will be calculated after verification of all complications and their classification according to Clavien, evaluated by Clavien-Dindo classification of surgical complications from Dindo et al. Minimum (0 points) - best results, maximum (100 points) - worst result (patient death)	30 days after surgery

Collaborators and Investigators

• Sponsor: City Clinical Hospital No.1 named after N.I. Pirogov
• Collaborators: Pirogov Russian National Research Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: incisional hernia; eTEP; transversus abdominis release; open TAR; endoscopic TAR
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 2907-2/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No