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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Pain
• Intervention / Treatment: Procedure: Minimally Invasive Gynecologic Surgery; Procedure: osteopathic manipulative treatment; Drug: Pain killer

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Carlo Alboni, MD, PhD; Phone Number: 0594224387; Email: alboni.carlo@aou.mo.it

Study Locations

• Italy
  • Modena, Italy, 41125
    • Recruiting
    • Carlo Alboni
    • Contact: Carlo Alboni, MD, PhD; Phone Number: 0594224387; Email: alboni.carlo@aou.mo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Analysis of postoperative complications using Clavien-Dindo classification	Analysis of postoperative (1 month after surgery) complications using Clavien-Dindo classification	1 month after surgery
Incidence of endometriosis among patients with chronic pelvic pain	Incidence of endometriosis among patients with chronic pelvic pain	Baseline

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria di Modena

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Endometriosis; Pelvic Pain; Minimally invasive Surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: 0024582/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I prefer to not share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No