An interventional study of osteopatic visceral mobilization in Endometriosis and Osteopathy in Diseases Classified Elsewhere, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Other
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's planned enrollment of 63 is close to the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
patients operated for endometriosis without osteopathic visceral mobilization
patients operated for endometriosis with osteopathic visceral mobilization
Other: osteopatic visceral mobilization
a combination of breathing and visceral mobilizations
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 year
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 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 1 year
fertility
Achieving pregnancy during the first postoperative year (yes or no)
Time frame: 1 year
number of days of sick leave
Compare the number of days of sick leave between the two groups
Time frame: 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.
Time frame: 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)
Time frame: 1 year
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University Hospital, Clermont-Ferrand