Open Vs. Endoscopic Transversus Abdominis Release Trial
NCT ID: NCT06195332
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2024-10-15
2025-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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open TAR
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
open TAR
Participants will undergo open TAR repair according to the assigned treatment arm.
endoscopic TAR
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
endoscopic TAR
Participants will undergo endoscopic TAR repair according to the assigned treatment arm.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* lateral hernia with/without midline
* refuse to give informed consent
18 Years
90 Years
ALL
No
Sponsors
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Pirogov Russian National Research Medical University
OTHER
City Clinical Hospital No.1 named after N.I. Pirogov
OTHER
Responsible Party
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Locations
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Clinical City Hospital #1 named after N.I. Pirogov
Moscow, , Russia
Countries
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Central Contacts
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Georgy Ivakhov, professor
Role: CONTACT
Phone: +79262844224
Facility Contacts
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Georgy Ivakhov, Prof
Role: primary
Other Identifiers
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2907-2/22
Identifier Type: -
Identifier Source: org_study_id