Impact on Quality of Life of Osteopathic Visceral Mobilizations After Endometriosis Surgery
NCT Number: NCT06553989
Acronym: MOVENDOP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometriosis|Osteopathy in Diseases Classified Elsewhere
Interventions: OTHER: osteopatic visceral mobilization
Sponsor: University Hospital, Clermont-Ferrand
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 63
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2028-09
Locations: CHU de Clermont-Ferrand, Clermont-Ferrand, France

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.

Primary Outcome Measures: 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: 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