Impact on Quality of Life of Osteopathic Visceral Mobilizations After Endometriosis Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
osteopatic visceral mobilization
Other interventiona combination of breathing and visceral mobilizations
Treatment groups
63 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Experimental groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
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
Time frame
pre-operative, 6 months and 12 months2
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
Time frame
pre-operative, 6 months and 12 months3
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
Time frame
pre-operative, 6 months and 12 months4
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
Time frame
pre-operative, 6 months and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov