Impact of Transversalis Fascia Repair on Hospital Stay, Quality of Life, and Complications in Total Extraperitoneal (TEP) Inguinal Hernia Repair: A Double-blind Randomized Controlled Trial.

Abstract

Background: We designed a study to determine the impact of transversalis fascia repair (TFR) during TEP surgery for inguinal hernias on hospital stay duration, recurrence rates, quality of life, and related adverse outcomes in a randomized, double-blinded, controlled clinical trial. We screened patients presenting with inguinal hernias requiring elective surgery.

Methods: Eligible patients were randomly allocated into 2 groups: the TFR group, whose inguinal ring defect was narrowed; and the Routine Treatment Group (RTG) group, whose defect left unchanged. The prespecified primary outcomes were the length of hospital stay and the time of surgery. Patients were followed for 6 months to be evaluated regarding the Visual Analogue Scale (VAS), the rate of recurrence and seroma formation, and their Carolina Comfort Scale (CCS) hernia-specific quality of life.

Results: A total of 60 patients were allocated to study arms with no significant differences in the baseline characteristics. The intervention did not have a significant impact on the duration of hospitalization. However, the operation time in the TFR group was significantly longer than in the RTG group (Cohen's d=-1.13, 95% CI: -1.67 to -0.58, P<0.001). In contrast, no statistically or clinically significant differences were noted between the groups concerning postoperative pain, analgesic usage, or rates of acute and chronic pain. Furthermore, the TFR group had a much lower risk of seroma formation during the first week after surgery compared with the routine nonclosing defect group, showing an almost 80% lower risk of seroma formation. However, this finding did not reach statistical significance.

Conclusion: Although the defect-closing approach resulted in longer operation times, our study did not demonstrate any beneficial effects on hospital stay duration, postoperative pain, or quality of life. However, this approach may reduce seroma formation in the first week postsurgery, which should be confirmed in future meta-analyses.

Trial registration: This trial was prospectively registered on the Iranian Registry of Clinical Trials on February 29, 2024 (IRCT20180312039067N2).