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Long-term Management of Patients Surgically Treated for Chronic Pelvic Pain by Minimally Invasive Surgery

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ClinicalTrials.gov Identifier: NCT04652011
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Carlo Alboni, MD, PhD, Azienda Ospedaliero-Universitaria di Modena

Brief Summary:
It is a retrospective observational study based on the analysis of the medical records of patients treated for chronic pelvic pain and benign gynecological pathologies at the Gynecology Unit of the University Hospital of Modena from 2010 to 2019. The aim of the study is to analyze the effects of medical and surgical treatments on chronic pelvic pain and associated pathologies.

Condition or disease Intervention/treatment
Pelvic Pain Procedure: Minimally Invasive Gynecologic Surgery Procedure: osteopathic manipulative treatment Drug: Pain killer

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Management of Patients With Benign Gynecological Pathology and Chronic Pelvic Pain and Follow-up After Minimally Invasive Surgery
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Group/Cohort Intervention/treatment
Patients with chronic pelvic pain
Patients with chronic pelvic pain and a benign gynecologic disease associated, referring to our Unit, medically or surgically treated from 2010 to 2019
Procedure: Minimally Invasive Gynecologic Surgery
Minimally Invasive Surgery for gynecologic disease (laparoscopy, robotic surgery, vaginal surgery)

Procedure: osteopathic manipulative treatment
Osteopathic manipulative treatment

Drug: Pain killer
Common pain killer (paracetamol, Ibuprofen, ketoprofen)




Primary Outcome Measures :
  1. Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after surgery [ Time Frame: Baseline and 6 months after surgery ]
    Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after surgery

  2. Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after Osteopathic manipulative treatment [ Time Frame: Baseline and 6 months after Osteopathic manipulative treatment ]
    Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after Osteopathic manipulative treatment


Secondary Outcome Measures :
  1. Change From Baseline in constipation on the constipation score system (CSS) by Agachan-Wexner at 6 months after surgery [ Time Frame: Baseline and 6 months after surgery ]
    Change From Baseline in constipation on the constipation score system (CSS) by Agachan-Wexner at 6 months after surgery

  2. Analysis of postoperative complications using Clavien-Dindo classification [ Time Frame: 1 month after surgery ]
    Analysis of postoperative (1 month after surgery) complications using Clavien-Dindo classification

  3. Incidence of endometriosis among patients with chronic pelvic pain [ Time Frame: Baseline ]
    Incidence of endometriosis among patients with chronic pelvic pain



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic pelvic pain and a benign gynecologic disease associated, referring to Gynecologic Unit of University Hospital of Modena, who underwent minimally invasive surgery from 2010 to 2019
Criteria

Inclusion Criteria:

  • Underwent Minimally invasive gynecologic surgery from 2010 to 2019
  • Chronic pelvic pain
  • Benign gynecologic disease (Endometriosis, myoma, adenomyosis, pelvic organ prolapse

Exclusion Criteria:

  • malignant gynecologic disease
  • chronic pelvic pain not linked to gynecologic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652011


Contacts
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Contact: Carlo Alboni, MD, PhD 0594224387 alboni.carlo@aou.mo.it

Locations
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Italy
Carlo Alboni Recruiting
Modena, Italy, 41125
Contact: Carlo Alboni, MD, PhD    0594224387    alboni.carlo@aou.mo.it   
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Modena
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Responsible Party: Carlo Alboni, MD, PhD, Dr. Carlo Alboni MD, PhD Head of Minimally Invasive and Robotic Gynecologic Surgery Unit University Hospital of Modena - Italy, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier: NCT04652011    
Other Study ID Numbers: 0024582/19
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: I prefer to not share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlo Alboni, MD, PhD, Azienda Ospedaliero-Universitaria di Modena:
Pelvic Pain
Endometriosis
Minimally invasive Surgery
Additional relevant MeSH terms:
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Pelvic Pain
Pain
Neurologic Manifestations
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs