Laparoscopic IPOM Plus vs. eTEP Trial

Comparison of Laparoscopic Intraperitoneal Onlay Mesh (IPOM Plus) and Extended Totally Extraperitoneal (eTEP) Repair for Incisional Hernia - a Randomized Controlled Trial

The survey will compare primary and secondary outcomes of laparoscopic intraperitoneal onlay mesh (IPOM plus) and extended totally extraperitoneal (eTEP) repair for incisional hernia.

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

Study Overview

• Status: Recruiting
• Conditions: Incisional Hernia of Midline of Abdomen
• Intervention / Treatment: Procedure: Lap IPOM plus; Procedure: eTEP

Detailed Description

The use of minimally invasive surgery for the treatment of patients with incisional ventral hernias has significant advantages over open surgery. According to the current guidelines, the optimal technique for IPOM repair is a combination of suturing hernia defect and implantation an intraperitoneal anti-adhesive coated mesh prosthesis - the so-called "IPOM plus" technology (R.Bittner et al., 2019). The development of laparoscopic surgery has led to the new minimally invasive technique for ventral hernia repair - extended-view totally extraperitoneal plasty (eTEP) (I. Belyansky et al., 2018). An important advantage of eTEP is the non-fixation technique of implant placement due to correct positioning compared to the need for combined fixation for IPOM or IPOM plus, which probably affects on the level of postoperative pain in the early postoperative period.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Sazhin, professor; Phone Number: +79163904180; Email: sazhin-av@yandex.ru
• Study Contact Backup: Name: Georgy Ivakhov, PhD; Phone Number: +79262844224; Email: ivakhovsurg@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Clinical City Hospital #1 named after N.I. Pirogov
    • Contact: Georgy Ivakhov, Prof; Phone Number: +79264578568; Email: ivakhovsurg@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• midline incisional hernia
• 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:

• primary ventral herna
• lateral hernia with/without midline
• defect width more than 6 cm
• refuse to give informed consent
• prior mesh placement in the retrorectus space

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Lap IPOM plus; Participants will undergo Lap IPOM plus repair according to the assigned treatment arm.; Other Names: Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repair
Active Comparator: 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	Procedure: eTEP; Participants will undergo eTEP repair according to the assigned treatment arm.; Other Names: Extended-view totally extraperitoneal ventral hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain on postoperative day 1	Pain score will be assessed using the Numeric Pain Rating Scale. The mean pain score is calculated between pain values at rest and on coughing. Participants verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.	postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain on postoperative days 7 and 30	Pain score will be assessed using the Numeric Pain Rating Scale. The mean pain score is calculated between pain values at rest and on physical activity. Participants verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.	postoperative 7 (±1) and 30 (±3) days
length of stay	From date of hospital admission until discharge. The length of hospital stay (days)	30 days after surgery
analgetic consumption	Consumption of analgesics during the first 48 hours after surgery	48 hours after surgery
number of participants with chronic pain	Persisted pain in surgical site more than 90 days after surgery. Pain score will be assessed using the Numeric Pain Rating Scale. Participants verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.	postoperative day 100 (±5 days)
postoperative complications	Number of participants with postoperative complications, evaluated by Clavien-Dindo classification of surgical complications from Dindo et al.	30 days after surgery
pain 6 hours after surgery	Pain score will be assessed using the Numeric Pain Rating Scale. The mean pain score is calculated between pain values at rest and on coughing. Participants verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.	6 hours (± 1 hour) after surgery

Collaborators and Investigators

• Sponsor: City Clinical Hospital No.1 named after N.I. Pirogov
• Collaborators: Pirogov Russian National Research Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pain; eTEP; incisional ventral hernia; IPOM
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 2907-1/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No