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NCT Number: NCT06553989

Impact on Quality of Life of Osteopathic Visceral Mobilizations After 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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Osteopathy in Diseases Classified Elsewhere Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location status: Recruiting

Location contact

Lise Laclautre

CONTACT

Nicolas Bourdel

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

osteopatic visceral mobilization

Other

a combination of breathing and visceral mobilizations

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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

  8. 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

  9. 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).

  10. 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

  11. 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

  12. fertility

    Time frame: 1 year

    Achieving pregnancy during the first postoperative year (yes or no)

  13. number of days of sick leave

    Time frame: 1 year

    Compare the number of days of sick leave between the two groups

  14. 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.

  15. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Impact on Quality of Life of Osteopathic Visceral Mobilizations in Patients Undergoing Post-operative ENDOmetriosis Surgery

Acronym: MOVENDOP

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 14, 2024
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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