Matovu Alphonsus, Nordin Pär, Wladis Andreas, Sandblom Gabriel, Elaju Moses, Lindmark Fredrik, Bladin Olof, Löfgren Jenny
Department of Surgery, Mubende Regional Referral Hospital, Mubende, Uganda.
Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
JAMA Surg. 2025 Jul 16. doi: 10.1001/jamasurg.2025.2244.
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.
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.
OAM in the control arm and MOAM in the intervention arm.
The primary outcome was groin hernia recurrence 1 year postoperatively.
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).
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.
ISRCTN Identifier: ISRCTN10330683.
低收入和中等收入国家的大多数女性无法获得腹腔镜腹股沟疝修补方法；因此，需要一种能够治疗腹股沟疝和股疝的开放技术。在无法使用腹腔镜方法的情况下，这可能是一种选择。
确定开放前路补片（OAM）修补术与改良开放前路补片（MOAM）修补术（包括打开腹横筋膜并用补片瓣覆盖股管）相比的安全性和有效性。
设计、地点和参与者：这是一项平行双臂双盲随机临床试验，于2019年10月至2023年2月在东非乌干达北部的2家公立医院进行。纳入研究的是18岁及以上患有原发性腹股沟疝、美国麻醉医师协会（ASA）分级为I或II级且能够给予知情同意的成年女性。
对照组采用OAM修补术，干预组采用MOAM修补术。
主要结局是术后1年腹股沟疝复发情况。
共有200名参与者（平均[标准差]年龄为52.7[14.0]岁）纳入研究；99名（49.5%）被分配接受OAM修补术，101名（50.5%）被分配接受MOAM修补术。近45%的参与者（200名中的89名）患有股疝；因此，对照组99名参与者中有35名（35.4%）接受了干预手术。术后1年，总体复发率为5.6%（195名参与者中的11名），意向性分析显示，对照组97名参与者中有4名（4.1%）复发，干预组98名参与者中有7名（7.1%）复发（绝对差异=-3.0个百分点；95%CI，-9.5至3.4；P=0.36）。
这项随机临床试验的结果表明，MOAM修补术是资源匮乏地区女性腹股沟疝修补的一个好选择。股疝在研究人群中非常常见，暴露股管对于检测这些疝至关重要。
ISRCTN标识符：ISRCTN10330683。
