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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06195332
Other study ID # 2907-2/22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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