EndometriosisMOVENDOPNCT06553989
Impact on Quality of Life of Osteopathic Visceral Mobilizations After Endometriosis Surgery
A study testing osteopatic visceral mobilization in people with Endometriosis and Osteopathy in Diseases Classified Elsewhere, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Osteopathy in Diseases Classified Elsewhere
- What is being tested?
- osteopatic visceral mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre
Nicolas Bourdel
About this study
Official title: 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.
- Being tested
- osteopatic visceral mobilization
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopatic visceral mobilizationOther
a combination of breathing and visceral mobilizations
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | patients operated for endometriosis without osteopathic visceral mobilization |
| Experimental group | Experimental | patients operated for endometriosis with osteopathic visceral mobilization Receives: Other: osteopatic visceral mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
Measured: 1 year
fertility
Achieving pregnancy during the first postoperative year (yes or no)
Measured: 1 year
number of days of sick leave
Compare the number of days of sick leave between the two groups
Measured: 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.
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start27 Jan 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Bourdel, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553989
- Sponsor's protocol ID
- RBHP 2023 BOURDEL
- Other IDs
- 2023-A02653-42
- Acronym
- MOVENDOP
- Status last verified
- Jan 2025
- First submitted
- 8 Aug 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Quality of Life of Osteopathic Visceral Mobilizations in Patients Undergoing Post-operative ENDOmetriosis Surgery
- ClinicalTrials.gov ID
- NCT06553989
- Acronym / sponsor ID
- MOVENDOP / RBHP 2023 BOURDEL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –patients operated for endometriosis without osteopathic visceral mobilization |
| Experimental group | Experimental | Other: osteopatic visceral mobilizationpatients operated for endometriosis with osteopathic visceral mobilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osteopatic visceral mobilizationa combination of breathing and visceral mobilizations | Other | Experimental group |
Primary outcome
Quality of life with the EHP-30 questionnaire score
Time frame: 1 year
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.
15 secondary outcomes
quality of life with score of the questionnaire EHP-30
Time frame: pre-operative, 6 months and 12 months
quality of life with score of the questionnaire GIQLI
Time frame: pre-operative, 6 months and 12 months
quality of life with score of the questionnaire FSFI
Time frame: pre-operative, 6 months and 12 months
quality of life with score of the questionnaire ICIQ-FLUTS
Time frame: pre-operative, 6 months and 12 months
quality of life with score of the questionnaire PCS
Time frame: pre-operative, 6 months and 12 months
pelvic pain
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
Time frame: pre-operative, 6 months and 12 months
evaluation of the cicatrisation
Time frame: post operative, 6 months and 12 months
evaluation of the abdominal flexibility
Time frame: 1 year
Use of additional care
Time frame: 1 year
consumption of analgesics and hormonal treatment
Time frame: 1 year
fertility
Time frame: 1 year
number of days of sick leave
Time frame: 1 year
compare patient profiles using the sub-domains of the EHP-30 questionnaire
Time frame: 1 year
patient compliance
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas Bourdel principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopatic visceral mobilization in people with Endometriosis and Osteopathy in Diseases Classified Elsewhere, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life with the EHP-30 questionnaire score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.