初步研究MOVENDOP方案——对子宫内膜异位症手术患者术后整骨腹部松动术生活质量的影响

Pilot study MOVENDOP protocol - impact on quality of life following postoperative osteopathic abdominal mobilizations in patients operated for endometriosis.

作者信息

Comptour Aurélie, Dechambenoit Caroline, Kwiatkowski Fabrice, Vidal Astrid, Duval Marie, De Antonio Marie, Jacobs Aurélie, Bourdel Nicolas

机构信息

INSERM, CIC CRECHE Unit, CHU Clermont-Ferrand, Department of Gynecological Surgery, Clermont-Ferrand, France.

IFSO, Institut de formation supérieure en ostéopathie, 4 Rue Gallieni, Vichy, France.

出版信息

PLoS One. 2025 May 8;20(5):e0323214. doi: 10.1371/journal.pone.0323214. eCollection 2025.

DOI:10.1371/journal.pone.0323214

PMID:40338925

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12061089/

Abstract

BACKGROUND

Surgery remains the gold standard for management of endometriosis, offering significant improvement in patient pelvic pain and quality of life (QoL). Postoperative tissue adhesions can however diminish these benefits, limiting the long-term effectiveness of the intervention. Despite the development of strategies and devices to reduce adhesion formation, their efficacy remains inconclusive.

OBJECTIVE

This study aims to propose and evaluate a novel approach involving early visceral mobilization and training of patients in abdominal self-mobilization as a means to improve QoL following surgery.

METHODS

This pilot study is a prospective, randomized, phase II superiority trial. Patients undergoing surgery for infiltrating endometriosis will be randomized, with a 2:1 ratio, into two groups. The intervention group (n = 42) will receive six sessions of osteopathic visceral mobilization with training in abdominal self-mobilization techniques, one preoperative, and five postoperative during the first month post-surgery. The control group (n = 21) will receive no osteopathic visceral mobilizations but will be offered an osteopathic session after one year. The primary endpoint is a minimum increase of 20 points (on a 100-point scale) in the Endometriosis Health Profile-30 (EHP-30) global score, at one year. Secondary endpoints include assessment of gastrointestinal quality of life (GIQLI), sexual function (FSFI), urinary symptoms (ICIQ-FLUTS), pain catastrophizing (PCS), as well as scar examination, pelvic pain, abdominal flexibility, use of medical and non-medical care, analgesic and hormonal treatments, pregnancy rate, physical activity, sedentary lifestyle and patient compliance. Statistical analyses will be based on a one-sided α=0.05 and β=0.15, assuming a standard deviation of 25 points in the EHP-30 global score. A total of 42 participants in the intervention group and 21 in the control group are required.

DISCUSSION

This trial aims to demonstrate that early and repeated osteopathic sessions following surgery for endometriosis may significantly improve patient QoL.

摘要

背景

手术仍然是子宫内膜异位症治疗的金标准，能显著改善患者的盆腔疼痛和生活质量（QoL）。然而，术后组织粘连会削弱这些益处，限制了该干预措施的长期有效性。尽管已开发出减少粘连形成的策略和器械，但其疗效仍不明确。

目的

本研究旨在提出并评估一种新方法，即早期内脏松动术和对患者进行腹部自我松动训练，作为改善术后生活质量的一种手段。

方法

这项前瞻性、随机、II期优效性试验。因浸润性子宫内膜异位症接受手术的患者将按2:1的比例随机分为两组。干预组（n = 42）将接受六次整骨内脏松动术，并接受腹部自我松动技术训练，术前一次，术后第一个月内术后五次。对照组（n = 21）不接受整骨内脏松动术，但在一年后会提供一次整骨治疗。主要终点是术后一年子宫内膜异位症健康概况-30（EHP-30）全球评分至少提高20分（满分100分）。次要终点包括评估胃肠道生活质量（GIQLI）、性功能（FSFI）、泌尿系统症状（ICIQ-FLUTS）、疼痛灾难化（PCS），以及疤痕检查、盆腔疼痛、腹部柔韧性、医疗和非医疗护理的使用、镇痛和激素治疗、妊娠率、身体活动、久坐生活方式和患者依从性。统计分析将基于单侧α = 0.05和β = 0.15，假设EHP-30全球评分的标准差为25分。干预组共需要42名参与者，对照组需要21名。