Open vs. Endoscopic Transversus Abdominis Release Trial

Incisional Hernia of Midline of Abdomen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195332
• Other study ID #: 2907-2/22
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: City Clinical Hospital No.1 named after N.I. Pirogov
• Contact: Alexander Sazhin, professor
• Phone: +79163904180
• Email: sazhin-av[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Incisional Hernia of Midline of Abdomen

Intervention

Procedure:
• open TAR
Participants will undergo open TAR repair according to the assigned treatment arm.
• endoscopic TAR
Participants will undergo endoscopic TAR repair according to the assigned treatment arm.

Locations

Country	Name	City	State
Russian Federation	Clinical City Hospital #1 named after N.I. Pirogov	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
City Clinical Hospital No.1 named after N.I. Pirogov	Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of stay after surgery	From date of operation until discharge	30 days after surgery
Secondary	duration of operation	time from beginning to the end of surgery	period of operation
Secondary	surgical site occurrences rate	incidence of all type of wound complications	30 days after surgery
Secondary	surgical site infection rate	incidence of wound infection	30 days after surgery
Secondary	rate of postoperative complications	number of participants with postoperative complications	30 days after surgery
Secondary	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
Secondary	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