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NCT04652011 Clinical Trial

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

Pelvic Pain Clinical Trial

Official title:
Long-term Management of Patients With Benign Gynecological Pathology and Chronic Pelvic Pain and Follow-up After Minimally Invasive Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04652011
Other study ID # 0024582/19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date July 1, 2021

Study information
Verified date December 2020
Source Azienda Ospedaliero-Universitaria di Modena
Contact Carlo Alboni, MD, PhD
Phone 0594224387
Email alboni.carlo@aou.mo.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date July 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Minimally Invasive Gynecologic Surgery
Minimally Invasive Surgery for gynecologic disease (laparoscopy, robotic surgery, vaginal surgery)
• osteopathic manipulative treatment
Osteopathic manipulative treatment
Drug:
• Pain killer
Common pain killer (paracetamol, Ibuprofen, ketoprofen)

Locations
Country Name City State
Italy Carlo Alboni Modena

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria di Modena

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after surgery Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after surgery Baseline and 6 months after surgery
Primary Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after Osteopathic manipulative treatment Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after Osteopathic manipulative treatment Baseline and 6 months after Osteopathic manipulative treatment
Secondary Change From Baseline in constipation on the constipation score system (CSS) by Agachan-Wexner at 6 months after surgery Change From Baseline in constipation on the constipation score system (CSS) by Agachan-Wexner at 6 months after surgery Baseline and 6 months after surgery
Secondary Analysis of postoperative complications using Clavien-Dindo classification Analysis of postoperative (1 month after surgery) complications using Clavien-Dindo classification 1 month after surgery
Secondary Incidence of endometriosis among patients with chronic pelvic pain Incidence of endometriosis among patients with chronic pelvic pain Baseline
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