Süsstrunk Julian, Baur Johannes, Sortino Rosita, Filser Jörg, Herzog Kim, Steinemann Daniel C, Müller Beat P, Angehrn Fiorenzo V
Clarunis, Department of Visceral Surgery, University Digestive Health Care Center, St. Clara Hospital and University Hospital Basel, Basel, Switzerland.
Discipline of Surgery, The Queen Elizabeth Hospital, University of Adelaide, Adelaide, South Australia, Australia.
Int J Surg Protoc. 2024 Sep 28;28(4):1-6. doi: 10.1097/SP9.0000000000000030. eCollection 2024 Oct 21.
Minimally invasive ventral hernia repair (MIVHR) is a frequently performed surgical procedure to address primary or incisional ventral hernias and is recommended by numerous societies. Various techniques are available for MIVHR, including the intraperitoneal onlay mesh (IPOM) procedure and the enhanced view totally extraperitoneal (eTEP) approach. While both techniques are increasingly applied, they continue to be subject of controversy in literature. Well-designed randomized controlled trials comparing both procedures are lacking. The objective of this study is to investigate whether eTEP is associated with a decreased level of postoperative pain compared to IPOM.
This is a prospective, multi-center, randomized, and blinded controlled trial. Patients presenting with primary or incisional epigastric, umbilical, or infraumbilical hernia with a transverse diameter >1 cm and ≤4 cm, or multiple hernias with a cumulative transverse diameter ≤4 cm, will be randomly assigned to undergo either IPOM or eTEP procedures. All patients and assessors of the study outcomes are blinded to the treatment allocation. The trial will be conducted at the St. Clara Hospital Basel, at the University Hospital Basel (Switzerland) and at the Innklinikum Altötting (Germany). It remains open for additional sites to be included. The multi-center design is chosen to minimize environmental bias related to perioperative anesthesiology and nursing care and to enhance participant recruitment. The primary outcome of this study is to evaluate postoperative pain (numeric rating scale and Patient-Reported Outcome Measurement Information System Pain Intensity Short Form 3a) 24 hours after the surgical procedure. Secondary outcomes include the assessment of pain at different times, length of hospital stay, operative time, readmission rate, intraoperative, and postoperative adverse events.
微创腹疝修补术（MIVHR）是一种常用于治疗原发性或切口性腹疝的外科手术，众多学会都推荐该手术。MIVHR有多种技术可供选择，包括腹腔内补片植入术（IPOM）和强化视野完全腹膜外修补术（eTEP）。虽然这两种技术的应用越来越广泛，但在文献中它们仍然是争议的焦点。缺乏比较这两种手术的精心设计的随机对照试验。本研究的目的是调查与IPOM相比，eTEP是否与术后疼痛程度降低相关。
这是一项前瞻性、多中心、随机、双盲对照试验。患有原发性或切口性上腹部、脐部或脐下疝，横径>1 cm且≤4 cm，或多个疝累计横径≤4 cm的患者，将被随机分配接受IPOM或eTEP手术。所有患者和研究结果评估者均对治疗分配不知情。该试验将在巴塞尔圣克拉拉医院、巴塞尔大学医院（瑞士）和阿尔特廷根医院（德国）进行。仍开放纳入其他地点。选择多中心设计是为了尽量减少与围手术期麻醉和护理相关的环境偏倚，并增加参与者招募。本研究的主要结果是评估手术后24小时的术后疼痛（数字评分量表和患者报告结局测量信息系统疼痛强度简表3a）。次要结果包括不同时间的疼痛评估、住院时间、手术时间、再入院率、术中及术后不良事件。
