Impact on Quality of Life of Osteopathic Visceral Mobilizations After Endometriosis Surgery (MOVENDOP)

January 31, 2025 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Recruiting
        • CHU de Clermont-Ferrand
        • Principal Investigator:
          • Nicolas Bourdel
        • Contact:
          • Lise Laclautre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
patients operated for endometriosis without osteopathic visceral mobilization
Experimental: Experimental group
patients operated for endometriosis with osteopathic visceral mobilization
Other: osteopatic visceral mobilization
a combination of breathing and visceral mobilizations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
quality of life with score of the questionnaire EHP-30
Time Frame: pre-operative, 6 months and 12 months
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
Time Frame: pre-operative, 6 months and 12 months
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
Time Frame: pre-operative, 6 months and 12 months
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
Time Frame: pre-operative, 6 months and 12 months
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
Time Frame: pre-operative, 6 months and 12 months
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
Time Frame: pre-operative, 6 hours after surgery, 1 day after surgery, 1 month after surgery, 6 months and 12 months
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
Time Frame: pre-operative, 6 months and 12 months
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
Time Frame: post operative, 6 months and 12 months
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
Compare the consumption of analgesics and hormonal treatment (name and dose of the medication) between the 2 groups
1 year
fertility
Time Frame: 1 year
Achieving pregnancy during the first postoperative year (yes or no)
1 year
number of days of sick leave
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas Bourdel, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBHP 2023 BOURDEL
  • 2023-A02653-42 (Other Identifier: 2023-A02653-42)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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