Clinical trial NCT06195332: Open Vs. Endoscopic Transversus Abdominis Release Trial
Official title: Comparison of Open and Endoscopic Transversus Abdominis Release for Midline Incisional Ventral Hernia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incisional Hernia of Midline of Abdomen
Keywords: incisional hernia
eTEP
open TAR
endoscopic TAR
transversus abdominis release
Lead sponsor: City Clinical Hospital No.1 named after N.I. Pirogov
Sponsor class: OTHER
Collaborators: name: Pirogov Russian National Research Medical University
First posted: 2024-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: length of stay after surgery
timeFrame: 30 days after surgery
Secondary outcomes:
measure: duration of operation
timeFrame: period of operation
measure: surgical site occurrences rate
timeFrame: 30 days after surgery
measure: surgical site infection rate
timeFrame: 30 days after surgery
measure: rate of postoperative complications
timeFrame: 30 days after surgery
measure: rate of postoperative complications Clavien 3a and higher
timeFrame: 30 days after surgery
measure: Comprehensive complication index
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinical City Hospital #1 named after N.I. Pirogov
Study officials:
References: