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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UNKNOWN
NA
72 participants
INTERVENTIONAL
2023-02-14
2024-03-31
Brief Summary
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The research hypothesis is the following: patients who underwent eTEP repair may experience 30% less pain, assessed on the NRS-11 scale by the end of postoperative day 1, compared with IPOM plus procedure
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Detailed Description
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The results of the first RCT comparing IPOM and eTEP ventral hernia repair were recently published (Mayank J. et al., 2022). It was demonstrated the benefits of eTEP repair in several aspects: less pain in the early postoperative period, as well as a faster return to physical activity and lower intervention costs. However, a significant limitation of this RCT is the analysis of interventions in a mixed group of patients with primary ventral and incisional hernias, as well as the use of IPOM procedure without suturing the hernia defect.
The sample size was determined based on the above hypothesis regarding the primary point of the study. Considering trial of Asencio F. et al. (2009) in a group of patients with incisional ventral hernias, the level of pain at the end of the first postoperative day after IPOM repair was 4.76 according to the VAS (visual analog scale) with a standard deviation of 1.975. Assuming α (type I error rate) 0.05, β 0.20, it would need a total sample size of 60 patients. Taking into account the probability of loss of patients in the evaluation of long-term results up to 20%, 72 patients will be required (36 patients per group).
Taking into account the inconsistency of the literature data on the level of pain in the early postoperative period after IPOM procedure for incisional ventral hernia repair, as well as the established primary point of the study, the investigators plan an additional calculation with correction of the sample size after evaluation intermediate results upon reaching 50% of enrolled patients of the initially established.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repair
Laparoscopic Intraperitoneal Onlay Mesh plus repair will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement and suturing hernia defect.
Lap IPOM plus
Participants will undergo Lap IPOM plus repair according to the assigned treatment arm.
Extended-view totally extraperitoneal ventral hernia repair
Extended-view totally extraperitoneal ventral hernia repair will be used to perform minimally invasive ventral hernia repair with retrorectus mesh placement
eTEP
Participants will undergo eTEP repair according to the assigned treatment arm.
Interventions
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Lap IPOM plus
Participants will undergo Lap IPOM plus repair according to the assigned treatment arm.
eTEP
Participants will undergo eTEP repair according to the assigned treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* defect width 2-6 cm
* ASA I-II class
* Elective hernia repair
* Considered eligible for minimally invasive ventral hernia repair
* Able to give informed consent
* Able to tolerate general anesthesia
Exclusion Criteria
* lateral hernia with/without midline
* defect width more than 6 cm
* refuse to give informed consent
* prior mesh placement in the retrorectus space
18 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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Facility Contacts
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Other Identifiers
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2907-1/22
Identifier Type: -
Identifier Source: org_study_id
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