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

NCT06553989 | Recruiting

• 2 other identifiers: RBHP 2023 BOURDEL2023-A02653-42
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis; Osteopathy in Diseases Classified Elsewhere

Outcome Measures

Primary Outcomes (1)

• Quality of life with the EHP-30 questionnaire score

  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.

  1 year

Secondary Outcomes (15)

• quality of life with score of the questionnaire EHP-30

  pre-operative, 6 months and 12 months

• quality of life with score of the questionnaire GIQLI

  pre-operative, 6 months and 12 months

• quality of life with score of the questionnaire FSFI

  pre-operative, 6 months and 12 months

• quality of life with score of the questionnaire ICIQ-FLUTS

  pre-operative, 6 months and 12 months

• quality of life with score of the questionnaire PCS

  pre-operative, 6 months and 12 months

Study Arms (2)

Control group

NO INTERVENTION

patients operated for endometriosis without osteopathic visceral mobilization

Experimental group

EXPERIMENTAL

patients operated for endometriosis with osteopathic visceral mobilization

Other: osteopatic visceral mobilization

Interventions

osteopatic visceral mobilization OTHER

a combination of breathing and visceral mobilizations

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Nicolas Bourdel

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 14, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

FR (1)