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.