Clinical trial NCT05528107: Laparoscopic IPOM Plus vs. eTEP Trial
Official title: Comparison of Laparoscopic Intraperitoneal Onlay Mesh (IPOM Plus) and Extended Totally Extraperitoneal (eTEP) Repair for Incisional Hernia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incisional Hernia of Midline of Abdomen
Keywords: incisional ventral hernia
IPOM
eTEP
pain
Lead sponsor: City Clinical Hospital No.1 named after N.I. Pirogov
Sponsor class: OTHER
Collaborators: name: Pirogov Russian National Research Medical University
First posted: 2022-09-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain on postoperative day 1
timeFrame: postoperative day 1
Secondary outcomes:
measure: pain on postoperative days 7 and 30
timeFrame: postoperative 7 (±1) and 30 (±3) days
measure: number of participants with chronic pain
timeFrame: postoperative day 100 (±5 days)
measure: length of stay
timeFrame: 30 days after surgery
measure: postoperative complications
timeFrame: 30 days after surgery
measure: analgetic consumption
timeFrame: 48 hours after surgery
measure: pain 6 hours after surgery
timeFrame: 6 hours (± 1 hour) after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinical City Hospital #1 named after N.I. Pirogov
Study officials:
References: