Clinical trial NCT06553989: Impact on Quality of Life of Osteopathic Visceral Mobilizations After Endometriosis Surgery
Official title: Impact on Quality of Life of Osteopathic Visceral Mobilizations in Patients Undergoing Post-operative ENDOmetriosis Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Osteopathy in Diseases Classified Elsewhere
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Quality of life with the EHP-30 questionnaire score
timeFrame: 1 year
Secondary outcomes:
measure: quality of life with score of the questionnaire EHP-30
timeFrame: pre-operative, 6 months and 12 months
measure: quality of life with score of the questionnaire GIQLI
timeFrame: pre-operative, 6 months and 12 months
measure: quality of life with score of the questionnaire FSFI
timeFrame: pre-operative, 6 months and 12 months
measure: quality of life with score of the questionnaire ICIQ-FLUTS
timeFrame: pre-operative, 6 months and 12 months
measure: quality of life with score of the questionnaire PCS
timeFrame: pre-operative, 6 months and 12 months
measure: pelvic pain
timeFrame: pre-operative, 6 hours after surgery, 1 day after surgery, 1 month after surgery, 6 months and 12 months
measure: quality of life with the sub-domains of the EHP-30 questionnaire
timeFrame: pre-operative, 6 months and 12 months
measure: evaluation of the cicatrisation
timeFrame: post operative, 6 months and 12 months
measure: evaluation of the abdominal flexibility
timeFrame: 1 year
measure: Use of additional care
timeFrame: 1 year
measure: consumption of analgesics and hormonal treatment
timeFrame: 1 year
measure: fertility
timeFrame: 1 year
measure: number of days of sick leave
timeFrame: 1 year
measure: compare patient profiles using the sub-domains of the EHP-30 questionnaire
timeFrame: 1 year
measure: patient compliance
timeFrame: 1 year
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Nicolas Bourdel
role: PRINCIPAL_INVESTIGATOR
References: