Impact on Quality of Life of Osteopathic Visceral Mobilizations After Endometriosis Surgery (MOVENDOP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Osteopathy in Diseases Classified Elsewhere
• Intervention / Treatment: Other: osteopatic visceral mobilization

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Nicolas Bourdel
    • Contact: Lise LACLAUTRE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; patients operated for endometriosis without osteopathic visceral mobilization
Experimental: Experimental group; patients operated for endometriosis with osteopathic visceral mobilization	Other: osteopatic visceral mobilization; a combination of breathing and visceral mobilizations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life with score of the questionnaire EHP-30	Compare changes in patients' quality of life between the control group and the experimental group with visceral mobilizations	pre-operative, 6 months and 12 months
quality of life with score of the questionnaire GIQLI	Compare changes in patients' quality of life between the control group and the experimental group with visceral mobilizations	pre-operative, 6 months and 12 months
quality of life with score of the questionnaire FSFI	Compare changes in patients' quality of life between the control group and the experimental group with visceral mobilizations	pre-operative, 6 months and 12 months
quality of life with score of the questionnaire ICIQ-FLUTS	Compare changes in patients' quality of life between the control group and the experimental group with visceral mobilizations	pre-operative, 6 months and 12 months
quality of life with score of the questionnaire PCS	Compare changes in patients' quality of life between the control group and the experimental group with visceral mobilizations	pre-operative, 6 months and 12 months
pelvic pain	Compare pelvic pain between the 2 groups using EVA Scale (Visual Analogic Scale (from 0 : no pain to 10 : worst pain possible)	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	Compare changes in patients' quality of life between the 2 groups regarding the sub-domains the EHP-30 questionnaire	pre-operative, 6 months and 12 months
evaluation of the cicatrisation	Examination of scar appearance by the surgeon : acquired healing, healing in progress or disunion	post operative, 6 months and 12 months
evaluation of the abdominal flexibility	Evaluation of abdominal flexibility with an EVA scale in the regions: right and left iliac fossa, hypogastrium at one year assessed by an independent osteopath between 0 and 10 (0 corresponding to normal flexibility and 10 to total rigidity).	1 year
Use of additional care	Compare the use of additional care between the 2 groups by collecting data on the type of consultations (gynecologist, general practitioner, midwife, pain center doctor, emergency doctor, osteopath, physiotherapist, acupuncturist, magnetizer, hypnotherapist, healer, ...) and the number of visits	1 year
consumption of analgesics and hormonal treatment	Compare the consumption of analgesics and hormonal treatment (name and dose of the medication) between the 2 groups	1 year
fertility	Achieving pregnancy during the first postoperative year (yes or no)	1 year
number of days of sick leave	Compare the number of days of sick leave between the two groups	1 year
compare patient profiles using the sub-domains of the EHP-30 questionnaire	In the experimental group, identify patient profiles based on the sub-domains of quality of life assessed during the pre-operative visit, and compare these different groups according to the improvement in patients' post-operative quality of life at one year.	1 year
patient compliance	evaluate the impact of compliance of patients in the visceral mobilization group on improved quality of life and abdominal flexibility (by collecting the number of osteopathic self-mobilizations performed each month following surgery and during1 year)	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Nicolas Bourdel, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: RBHP 2023 BOURDEL; 2023-A02653-42 (Other Identifier: 2023-A02653-42)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No