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Recruiting Not applicable

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

NCT06553989 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-01-27
Last updated
2025-02-04

Condition(s) studied

EndometriosisOsteopathy in Diseases Classified Elsewhere

Investigational drug(s) / intervention(s)

osteopatic visceral mobilization

osteopatic visceral mobilization: a combination of breathing and visceral mobilizations

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Quality of life with the EHP-30 questionnaire score — 1 year
    Percentage change in baseline questionnaire score (EHP-30) between pre-operative visit and 1 year. The EHP-30 contains 30 items and ranges from 0 (best health) to 100 (worst health). The items in the baseline questionnaire are grouped into 5 main sub-domains: pain, control and powerlessness, emotional well-being, social support and self-image.

Trial sites (1)

FacilityCityRegionStatus
CHU de Clermont-Ferrand Clermont-Ferrand France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06553989 on ClinicalTrials.gov ↗ ← All trials in France