Open Vs. Endoscopic Transversus Abdominis Release Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: open TAR, endoscopic TAR.
- Who it may be relevant to
- Registry conditions: Incisional Hernia of Midline of Abdomen. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Open and Endoscopic Transversus Abdominis Release for Midline Incisional Ventral Hernia - a Randomized Controlled Trial
Overview
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).
Interventions
- Procedure open TAR
Participants will undergo open TAR repair according to the assigned treatment arm. - Procedure endoscopic TAR
Participants will undergo endoscopic TAR repair according to the assigned treatment arm.
Primary outcome measures
- length of stay after surgery [Time frame: 30 days after surgery]
Secondary outcome measures (6)
- duration of operation [Time frame: period of operation]
- surgical site occurrences rate [Time frame: 30 days after surgery]
- surgical site infection rate [Time frame: 30 days after surgery]
- rate of postoperative complications [Time frame: 30 days after surgery]
- rate of postoperative complications Clavien 3a and higher [Time frame: 30 days after surgery]
- Comprehensive complication index [Time frame: 30 days after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Clinical City Hospital #1 named after N.I. Pirogov — Moscow
Identifiers
NCT: NCT06195332 · 2907-2/22