Incisional Hernia of Midline of AbdomenNCT05528107
Laparoscopic IPOM Plus vs. eTEP Trial
A study testing Lap IPOM plus and eTEP 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
The survey will compare primary and secondary outcomes of laparoscopic intraperitoneal onlay mesh (IPOM plus) and extended totally extraperitoneal (eTEP) repair for incisional hernia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia of Midline of Abdomen
- What is being tested?
- Lap IPOM plus and eTEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteRussia
- Study dates
- 14 Feb 2023to 5 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Incisional Hernia of Midline of Abdomen
- Being tested
- Lap IPOM plus, eTEP
- Keywords
- incisional ventral hernia, IPOM, eTEP, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lap IPOM plusProcedure or surgery
Also called Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repair
Participants will undergo Lap IPOM plus repair according to the assigned treatment arm.
eTEPProcedure or surgery
Also called Extended-view totally extraperitoneal ventral hernia repair
Participants will undergo eTEP repair according to the assigned treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repair | Active comparator | 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. Receives: Procedure: Lap IPOM plus |
| Extended-view totally extraperitoneal ventral hernia repair | Active comparator | Extended-view totally extraperitoneal ventral hernia repair will be used to perform minimally invasive ventral hernia repair with retrorectus mesh placement Receives: Procedure: eTEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative day 1
Secondary outcomes (6)
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.
Measured: 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.
Measured: postoperative day 100 (±5 days)
length of stay
From date of hospital admission until discharge. The length of hospital stay (days)
Measured: 30 days after surgery
postoperative complications
Number of participants with postoperative complications, evaluated by Clavien-Dindo classification of surgical complications from Dindo et al.
Measured: 30 days after surgery
analgetic consumption
Consumption of analgesics during the first 48 hours after surgery
Measured: 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.
Measured: 6 hours (± 1 hour) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start14 Feb 2023
- Primary completion25 Apr 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 72 participants (actual)
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
- NCT05528107
- Sponsor's protocol ID
- 2907-1/22
- Status last verified
- May 2026
- First submitted
- 30 Aug 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ivakhov GB, Andriyashkin AV, Kalinina AA, Kuzmauskas D, Titkova SM, Mamadumarov VA, Nechay TV, Sazhin AV. Comparison of laparoscopic intraperitoneal onlay mesh (IPOM Plus) and extended totally extraperitoneal (eTEP RS) repair for incisional hernia - a randomized clinical trial. Hernia. 2026 Sep 4;30(1):340. doi: 10.1007/s10029-026-03846-w.
PubMed 42696155
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Intraperitoneal Onlay Mesh (IPOM Plus) and Extended Totally Extraperitoneal (eTEP) Repair for Incisional Hernia - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05528107
- Acronym / sponsor ID
- 2907-1/22
- Conditions
- Incisional Hernia of Midline of Abdomen
- Keywords
- incisional ventral hernia, IPOM, eTEP, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- City Clinical Hospital No.1 named after N.I. PirogovUniversity, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 6 Sep 2022 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repair | Active comparator | Procedure: Lap IPOM plusLaparoscopic Intraperitoneal Onlay Mesh plus repair will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement and suturing hernia defect. |
| Extended-view totally extraperitoneal ventral hernia repair | Active comparator | Procedure: eTEPExtended-view totally extraperitoneal ventral hernia repair will be used to perform minimally invasive ventral hernia repair with retrorectus mesh placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- midline incisional hernia
- defect width 2-6 cm
- ASA I-II class
- Elective hernia repair
- Considered eligible for minimally invasive ventral hernia repair
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Lap IPOM plusAlso: Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repairParticipants will undergo Lap IPOM plus repair according to the assigned treatment arm. | Procedure or surgery | Laparoscopic Intraperitoneal Onlay Mesh plus ventral hernia repair |
| eTEPAlso: Extended-view totally extraperitoneal ventral hernia repairParticipants will undergo eTEP repair according to the assigned treatment arm. | Procedure or surgery | Extended-view totally extraperitoneal ventral hernia repair |
Primary outcome
pain on postoperative day 1
Time frame: 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.
6 secondary outcomes
pain on postoperative days 7 and 30
Time frame: postoperative 7 (±1) and 30 (±3) days
number of participants with chronic pain
Time frame: postoperative day 100 (±5 days)
length of stay
Time frame: 30 days after surgery
postoperative complications
Time frame: 30 days after surgery
analgetic consumption
Time frame: 48 hours after surgery
pain 6 hours after surgery
Time frame: 6 hours (± 1 hour) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 42696155Ivakhov GB, Andriyashkin AV, Kalinina AA, Kuzmauskas D, Titkova SM, Mamadumarov VA, Nechay TV, Sazhin AV. Comparison of laparoscopic intraperitoneal onlay mesh (IPOM Plus) and extended totally extraperitoneal (eTEP RS) repair for incisional hernia - a randomized clinical trial. Hernia. 2026 Sep 4;30(1):340. doi: 10.1007/s10029-026-03846-w.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lap IPOM plus and eTEP 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 28 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain on postoperative day 1 (time frame: postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05528107, which also lists 1 linked publication.
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 28 May 2026.