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

• Conditions: Pelvic Pain
• Interventions: Procedure: Minimally Invasive Gynecologic Surgery; Procedure: osteopathic manipulative treatment; Drug: Pain killer

• Registration Number: NCT04652011
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-11-16
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03
• Primary Completion: 2021-04-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic pelvic pain	Minimally Invasive Gynecologic Surgery	Patients with chronic pelvic pain and a benign gynecologic disease associated, referring to our Unit, medically or surgically treated from 2010 to 2019
Patients with chronic pelvic pain	osteopathic manipulative treatment	Patients with chronic pelvic pain and a benign gynecologic disease associated, referring to our Unit, medically or surgically treated from 2010 to 2019
Patients with chronic pelvic pain	Pain killer	Patients with chronic pelvic pain and a benign gynecologic disease associated, referring to our Unit, medically or surgically treated from 2010 to 2019

Primary Outcome Measures

Name	Time	Method
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 surgery
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	Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after Osteopathic manipulative treatment

Secondary Outcome Measures

Name	Time	Method
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	Change From Baseline in constipation on the constipation score system (CSS) by Agachan-Wexner at 6 months after surgery
Analysis of postoperative complications using Clavien-Dindo classification	1 month after surgery	Analysis of postoperative (1 month after surgery) complications using Clavien-Dindo classification
Incidence of endometriosis among patients with chronic pelvic pain	Baseline	Incidence of endometriosis among patients with chronic pelvic pain

Trial Locations

Locations (1)

Carlo Alboni; 🇮🇹 Modena, Italy