Open Anterior Mesh Repair vs Modified Open Anterior Mesh Repair for Groin Hernia in Women: A Randomized Clinical Trial.

Abstract

Importance Most women in low- and middle-income countries lack access to laparoscopic methods for groin hernia repair; therefore, an open technique through which both inguinal and femoral hernias can be treated is needed. This could be an option in the absence or inability to use laparoscopic methods. Objective To determine the safety and effectiveness of open anterior mesh (OAM) repair compared with modified open anterior mesh (MOAM) repair, which includes opening the transversalis fascia and covering the femoral canal with a mesh flap. Design, Setting, and Participants This was a parallel, 2-arm, double-blind, randomized clinical trial conducted in Northern Uganda, in East Africa, at 2 public hospitals between October 2019 and February 2023. Included in the study were adult women 18 years and older with a primary groin hernia, American Society of Anesthesiologists (ASA) class I or II, and the ability to give informed consent. Interventions OAM in the control arm and MOAM in the intervention arm. Main Outcomes and Measures The primary outcome was groin hernia recurrence 1 year postoperatively. Results A total of 200 participants (mean [SD] age, 52.7 [14.0] years) were included in the study; 99 (49.5%) were allocated to OAM repair, and 101 (50.5%) were allocated to MOAM repair. Nearly 45% of the participants (89 of 200) had a femoral hernia; therefore, 35 of 99 participants (35.4%) in the control arm received the intervention procedure. One year postoperatively, the overall recurrence was 5.6% (11 of 195 participants), and the intention-to-treat analysis showed that 4 of 97 participants (4.1%) in the control arm and 7 of 98 participants (7.1%) in the intervention arm had recurrence (absolute difference = -3.0 percentage points; 95% CI, -9.5 to 3.4; P = .36). Conclusions and Relevance Results of this randomized clinical trial demonstrate that the MOAM repair was a good option for groin hernia repair in women in low-resource settings. Femoral hernias were very common in the study population, and exposure of the femoral canal was essential to detect these hernias. Trial Registration ISRCTN Identifier: ISRCTN10330683.