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

NCT04652011 | Unknown

• 1 other identifier: 0024582/19
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain

Keywords

Pelvic Pain; Endometriosis; Minimally invasive Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

  1 month after surgery

• Incidence of endometriosis among patients with chronic pelvic pain

  Baseline

Study Arms (1)

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; Procedure: osteopathic manipulative treatment; Drug: Pain killer

Interventions

Minimally Invasive Gynecologic Surgery PROCEDURE

Minimally Invasive Surgery for gynecologic disease (laparoscopy, robotic surgery, vaginal surgery)

Patients with chronic pelvic pain

osteopathic manipulative treatment PROCEDURE

Osteopathic manipulative treatment

Patients with chronic pelvic pain

Pain killer DRUG

Common pain killer (paracetamol, Ibuprofen, ketoprofen)

Patients with chronic pelvic pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Study Sites (1)

Carlo Alboni

Modena, 41125, Italy

RECRUITING

MeSH Terms

Conditions

Pelvic Pain; Endometriosis

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Carlo Alboni, MD, PhD

CONTACT

0594224387; alboni.carlo@aou.mo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Carlo Alboni MD, PhD Head of Minimally Invasive and Robotic Gynecologic Surgery Unit University Hospital of Modena - Italy

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 3, 2020
• Study Start: October 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)