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Robot-assisted versus standard laparoscopic approach of total hysterectomy for deep infiltrating endometriosis and adenomyosis (ENDORAS TRIAL): study protocol for a randomised controlled trial

Por: Renso · M. · Bendifallah · S. · Estrade · J.-P. · Merlot · B. · Roman · H. · Vidal · F. · Collinet · P.
Introduction

Endometriosis affects 5–10% of women during reproductive years, with a 20–30% incidence among those with infertility. Deep infiltrating endometriosis (DIE) affects 10–15% of women of childbearing age and 50% of infertile women. When hormonal therapy and conservative surgery prove ineffective, total hysterectomy with or without bilateral salpingo-oophorectomy may be the ultimate therapeutic option. Laparoscopic surgery is the gold standard for treating endometriosis, offering effective disease eradication, safety, reduced pain, shorter hospital stay and faster recovery compared with laparotomy. However, patients undergoing total laparoscopic hysterectomy with DIE have higher risks of complications and organ damage, particularly urinary tract damage. Robot-assisted laparoscopic hysterectomy has emerged as a promising alternative, with a significantly lower conversion rate than total laparoscopic hysterectomy in patients with endometriosis. This study evaluates the safety and efficacy of robot-assisted total laparoscopic hysterectomy (RATLH) versus total laparoscopic hysterectomy (TLH) in the management of DIE. We hypothesise that robot-assisted laparoscopic hysterectomy will result in fewer complications and better outcomes compared with total laparoscopic hysterectomy in DIE patients.

Methods and analysis

The ENDORAS trial is a prospective, multicentre, open-label, randomised controlled trial conducted in French reference hospitals specialising in endometriosis surgery. A total of 224 adult women patients will be enrolled in this study if they have DIE with adenomyosis, and without digestive tract involvement as confirmed by MRI. Participants will be randomised to undergo either RATLH or TLH. The primary outcome will be the intraoperative and postoperative complication rates, classified according to the Clavien-Dindo classification (grade 2 or above) at the 3-month postoperative follow-up. Among the secondary outcomes, we will evaluate the quality of life using various questionnaires, including the Endometriosis Health Profile-30, the Short Form-306 and the Female Sexual Function Index.

Ethics and dissemination

The ENDORAS trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practice guidelines. All trial documents and procedures have been reviewed and approved by the Ethics Committee Ile de France II (approval ID number: 24.01408.000300). Informed consent will be obtained during the preoperative check-up by the operating gynaecologist. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.

Trial registration number

NCT06445179. Registered on 14 November 2024.

Lived experiences of recovery following musculoskeletal trauma 6 months following injury in the UK: a qualitative study

Por: Middlebrook · N. · Heneghan · N. R. · Moffatt · M. · Silvester · L. · Falla · D. · Rushton · A. B. · Soundy · A.
Objectives

Traumatic musculoskeletal injuries are common and often life changing. The 6-month period following injury is a critical phase in recovery, during which engagement with rehabilitation professionals can be key to achieving positive outcomes. However, there is limited understanding of which aspects of recovery matter most to patients, how they define a successful recovery and what this looks like when captured during the lived recovery process. The aim of this study was to explore patients’ views and perceptions of recovery following musculoskeletal trauma and to understand what constitutes successful recovery at 6 months postinjury.

Design

Qualitative study using interpretative phenomenological analysis through semi-structured interviews.

Setting

Major trauma centre in the UK.

Participants

13 participants (mean age (SD) 51 (17) years, 69% male) completed the interview. Eligibility criteria: adults >18 years, musculoskeletal injury from a traumatic event and ability to communicate in English. Purposive sampling included age, gender, injury severity and injury type. Interviews were audio recorded and transcribed verbatim.

Results

Three main themes were identified: (1) The recovery journey: participants reflected on their recovery while still processing the accident/injuries. They often drew on other people’s experiences to make sense of their recovery. Recovery was accompanied by a range of negative emotions and personal challenges. (2) The outcome: participants used multiple strategies to work towards recovery, guided by personalised individual goals. A successful recovery was defined as their ‘normal’. (3) Healthcare/clinicians impact recovery: Participants reported confusion and mixed messages from healthcare professionals, leading to uncertainty around injury management. Fragmented care pathway and difficulties accessing healthcare and support were also highlighted.

Conclusions

Recovery at 6 months post injury involves a complex interplay of physical and emotional factors. This period can be particularly challenging to navigate, often with no or limited support. There is a need for a targeted, individualised approach to guide patients through this period of recovery. Participants’ focus was on the outcome following their injury, setting goals for the future, with successful recovery defined as ‘normal’. Further research is needed to support clinicians in developing effective psychologically informed rehabilitation plans.

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