An interventional study of Lap IPOM plus and eTEP in Incisional Hernia of Midline of Abdomen, sponsored by City Clinical Hospital No.1 named after N.I. Pirogov. Completed at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by City Clinical Hospital No.1 named after N.I. Pirogov · Not applicable, Interventional, and Treatment
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
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.
2,216 studies on the registry are indexed under Pain; 915 are open to participants now.
This study's enrollment of 72 is close to the median of 70 across 1,901 interventional studies indexed under Pain.
Browse Pain studies →City Clinical Hospital No.1 named after N.I. Pirogov is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 Lap IPOM plus repair according to the assigned treatment arm.
Also known as: Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repair
Participants will undergo eTEP repair according to the assigned treatment arm.
Also known as: Extended-view totally extraperitoneal ventral hernia repair
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.
Time frame: postoperative day 1
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.
Time frame: postoperative 7 (±1) and 30 (±3) days
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.
Time frame: postoperative day 100 (±5 days)
length of stay
From date of hospital admission until discharge. The length of hospital stay (days)
Time frame: 30 days after surgery
postoperative complications
Number of participants with postoperative complications, evaluated by Clavien-Dindo classification of surgical complications from Dindo et al.
Time frame: 30 days after surgery
analgetic consumption
Consumption of analgesics during the first 48 hours after surgery
Time frame: 48 hours 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.
Time frame: 6 hours (± 1 hour) after surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
City Clinical Hospital No.1 named after N.I. Pirogov