Pain and quality of life after laparoscopic transabdominal preperitoneal hernioplasty with different ways of fixing the peritoneum. Results of early completion randomized clinical trial

Abstract

To compare and statistically evaluate the severity of pain syndrome and quality of life depending on the method of fixation of the parietal peritoneum during laparoscopic hernia repair (suture fixation or the use of tack fixation). A randomized clinical trial was conducted from May to June 2021 at the Lomonosov Moscow State University Medical Center. It was planned to observe patients for a year. In the first group, the fixation of the parietal peritoneum was performed using suture fixation, in the second group, the peritoneal flap was fixed using a fixation device. In the course of statistical data processing, it was planned to study the dependence of the duration of the operation, the severity of the pain syndrome in the early postoperative period, the frequency of complications, the quality of life of patients in the postoperative period on the chosen method of the fixation of the parietal peritoneum. At the initial stage of the study, 8 patients with inguinal hernias were selected in the first group during randomization, and 6 patients were selected in the second group. Each patient of the second group in the early postoperative period had a more pronounced local pain, protective muscle tension in the projection of fixation of the parietal peritoneum with tacks, which was accompanied by negative psychoemotional reactions, an increase in the dose of analgesic drugs. Due to the revealed features of the early postoperative period in patients of second group, it was considered unethical and inappropriate to continue the study within the protocol. The results obtained do not allow us to draw statistically supported conclusions. The solution of the problem of the peritoneal flap fixation method is possible in two ways: abandoning stapler fixation in favor of suture or conducting additional clinical studies with an analysis of the impact of the choice of peritoneal fixation technique not only on acute and chronic postoperative pain, but on quality of life in the early and delayed postoperative periods.