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Recruiting NCT06553989

Impact on Quality of Life of Osteopathic Visceral Mobilizations After Endometriosis Surgery

No phase Interventional Endometriosis Osteopathy in Diseases Classified Elsewhere

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: osteopatic visceral mobilization.
Who it may be relevant to
Registry conditions: Endometriosis, Osteopathy in Diseases Classified Elsewhere. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Impact on Quality of Life of Osteopathic Visceral Mobilizations in Patients Undergoing Post-operative ENDOmetriosis Surgery

Overview

One of the most common post-operative complications of gynaecological surgery, and in particular endometriosis surgery, is the formation of peritoneal adhesions. After laparotomy, it affects up to 90% of patients. Minimally invasive techniques (such as laparoscopy) reduce the risk of adhesion formation, but cannot totally prevent it. Adhesions can lead to chronic pelvic pain, dyspareunia, digestive disorders and infertility. Various strategies and devices have been developed to try and limit adhesion formation, but their effectiveness has not been fully proven in the literature. The only real treatment for adhesions is adhesiolysis, although adhesions often reform. The quality of surgery remains the best means of preventing adhesion formation. To reduce the morbidity associated with pelvic adhesions, it is essential to develop alternative, non-invasive, anti-adhesive methods such as manual osteopathic visceral mobilization.

Interventions

  • Other osteopatic visceral mobilization
    a combination of breathing and visceral mobilizations

Primary outcome measures

  • Quality of life with the EHP-30 questionnaire score [Time frame: 1 year]
Secondary outcome measures (12)
  • quality of life with score of the questionnaire EHP-30 [Time frame: pre-operative, 6 months and 12 months]
  • quality of life with score of the questionnaire GIQLI [Time frame: pre-operative, 6 months and 12 months]
  • quality of life with score of the questionnaire FSFI [Time frame: pre-operative, 6 months and 12 months]
  • quality of life with score of the questionnaire ICIQ-FLUTS [Time frame: pre-operative, 6 months and 12 months]
  • quality of life with score of the questionnaire PCS [Time frame: pre-operative, 6 months and 12 months]
  • pelvic pain [Time frame: pre-operative, 6 hours after surgery, 1 day after surgery, 1 month after surgery, 6 months and 12 months]
  • quality of life with the sub-domains of the EHP-30 questionnaire [Time frame: pre-operative, 6 months and 12 months]
  • evaluation of the cicatrisation [Time frame: post operative, 6 months and 12 months]
  • evaluation of the abdominal flexibility [Time frame: 1 year]
  • Use of additional care [Time frame: 1 year]
  • consumption of analgesics and hormonal treatment [Time frame: 1 year]
  • fertility [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Woman of legal age
  • Indication for surgery for infiltrating endometriosis
  • Able to give informed consent to participate in research
  • Patient included in NO ENDO (national endometriosis observatory promoted by Clermont-Ferrand University Hospital)

Exclusion criteria

  • Indication for surgery for superficial endometriosis
  • Patient of legal age, under guardianship or trusteeship
  • Pregnant or breast-feeding patient
  • Patients not affiliated to the social security system
  • Patients who do not speak French
  • Patients under court protection
  • Simultaneous participation in another study
  • Refusal to participate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT06553989 · RBHP 2023 BOURDEL · 2023-A02653-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗