Open Vs. Endoscopic Transversus Abdominis Release Trial

NCT06195332 | Recruiting

• 1 other identifier: 2907-2/22
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Incisional Hernia of Midline of Abdomen

Keywords

incisional hernia; eTEP; open TAR; endoscopic TAR; transversus abdominis release

Outcome Measures

Primary Outcomes (1)

• length of stay after surgery

  From date of operation until discharge

  30 days after surgery

Secondary Outcomes (6)

• duration of operation

  period of operation

• surgical site occurrences rate

  30 days after surgery

• surgical site infection rate

  30 days after surgery

• rate of postoperative complications

  30 days after surgery

• rate of postoperative complications Clavien 3a and higher

  30 days after surgery

Study Arms (2)

open TAR

ACTIVE COMPARATOR

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

endoscopic TAR

ACTIVE COMPARATOR

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

Interventions

open TAR PROCEDURE

Participants will undergo open TAR repair according to the assigned treatment arm.

Also known as: open transversus abdominis release

open TAR

endoscopic TAR PROCEDURE

Participants will undergo endoscopic TAR repair according to the assigned treatment arm.

Also known as: endoscopic transversus abdominis release

endoscopic TAR

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Clinical City Hospital #1 named after N.I. Pirogov

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

Alexander Sazhin, professor

CONTACT

+79163904180; sazhin-av@yandex.ru

Georgy Ivakhov, professor

CONTACT

+79262844224

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: October 15, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)