Incisional Hernia of Midline of AbdomenNCT06195332
Open Vs. Endoscopic Transversus Abdominis Release Trial
A study testing open TAR and endoscopic TAR in people with Incisional Hernia of Midline of Abdomen, run by City Clinical Hospital No.1 named after N.I. Pirogov at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Incisional Hernia of Midline of Abdomen
- What is being tested?
- open TAR and endoscopic TAR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteRussia
- Study dates
- 15 Oct 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- primary ventral hernia
- lateral hernia with/without midline
- refuse to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Georgy Ivakhov, professor contact
Russia1 site, 1 recruiting
- Recruiting
Clinical City Hospital #1 named after N.I. Pirogov
Moscow
Georgy Ivakhov, Prof, +79264578568, ivakhovsurg@gmail.com
About this study
Official title: Comparison of Open and Endoscopic Transversus Abdominis Release for Midline Incisional Ventral Hernia - a Randomized Controlled Trial
This study aims to comparatively evaluate the early and long-term results of open and endoscopic TAR procedure for large midline incisional ventral hernias.
Read the 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).
- Conditions
- Incisional Hernia of Midline of Abdomen
- Being tested
- open TAR, endoscopic TAR
- Keywords
- incisional hernia, eTEP, open TAR, endoscopic TAR, transversus abdominis release
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open TARProcedure or surgery
Also called open transversus abdominis release
Participants will undergo open TAR repair according to the assigned treatment arm.
endoscopic TARProcedure or surgery
Also called endoscopic transversus abdominis release
Participants will undergo endoscopic TAR repair according to the assigned treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| open TAR | Active comparator | 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 Receives: Procedure: open TAR |
| endoscopic TAR | Active comparator | 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 Receives: Procedure: endoscopic TAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay after surgery
From date of operation until discharge
Measured: 30 days after surgery
Secondary outcomes (6)
duration of operation
time from beginning to the end of surgery
Measured: period of operation
surgical site occurrences rate
incidence of all type of wound complications
Measured: 30 days after surgery
surgical site infection rate
incidence of wound infection
Measured: 30 days after surgery
rate of postoperative complications
number of participants with postoperative complications
Measured: 30 days after surgery
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.
Measured: 30 days after surgery
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)
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start15 Oct 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia of Midline of AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City Clinical Hospital No.1 named after N.I. Pirogov
- Sponsor type
- University, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195332
- Sponsor's protocol ID
- 2907-2/22
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open and Endoscopic Transversus Abdominis Release for Midline Incisional Ventral Hernia - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06195332
- Acronym / sponsor ID
- 2907-2/22
- Conditions
- Incisional Hernia of Midline of Abdomen
- Keywords
- incisional hernia, eTEP, open TAR, endoscopic TAR, transversus abdominis release
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- City Clinical Hospital No.1 named after N.I. PirogovUniversity, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open TAR | Active comparator | Procedure: open TAROpen 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 |
| endoscopic TAR | Active comparator | Procedure: endoscopic TAREndoscopic 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- midline incisional hernia
- defect width from 8 till 12 cm
- ASA I-III class
- able to give informed consent
- elective hernia repair
Key exclusion criteria (3 listed)
- primary ventral hernia
- lateral hernia with/without midline
- refuse to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open TARAlso: open transversus abdominis releaseParticipants will undergo open TAR repair according to the assigned treatment arm. | Procedure or surgery | open TAR |
| endoscopic TARAlso: endoscopic transversus abdominis releaseParticipants will undergo endoscopic TAR repair according to the assigned treatment arm. | Procedure or surgery | endoscopic TAR |
Primary outcome
length of stay after surgery
Time frame: 30 days after surgery
From date of operation until discharge
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georgy Ivakhov, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open TAR and endoscopic TAR in people with Incisional Hernia of Midline of Abdomen, run by City Clinical Hospital No.1 named after N.I. Pirogov at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Sazhin, professor (+79163904180, sazhin-av@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay after surgery (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.