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

NCT ID: NCT06553989

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2028-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control group

patients operated for endometriosis without osteopathic visceral mobilization

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

patients operated for endometriosis with osteopathic visceral mobilization

Group Type: EXPERIMENTAL

osteopatic visceral mobilization

Intervention Type: OTHER

a combination of breathing and visceral mobilizations

Interventions

osteopatic visceral mobilization

a combination of breathing and visceral mobilizations

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Bourdel

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

334.73.754.963

Facility Contacts

Lise Laclautre

Role: primary

Other Identifiers

2023-A02653-42

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2023 BOURDEL

Identifier Type: -

Identifier Source: org_study_id