Status:

COMPLETED

Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery

Lead Sponsor:

University of Cagliari

Conditions:

Endometriosis

Pelvic Prolapse

Eligibility:

FEMALE

Brief Summary

The goal of this retrospective observational study is to evaluate the efficacy, safety, and practicality of an organ suspension technique with adjustable tension suture in facilitating minimally invas...

Detailed Description

This retrospective observational study, conducted at the University Hospital of Cagliari in Italy, is focused on providing a comprehensive evaluation of an innovative organ suspension (OS) technique u...

Eligibility Criteria

Inclusion

  • Patients who underwent multiport or single-site-port laparoscopic surgery with at least one transient pelvic organ suspension.
  • Surgeries performed between March 2019 and May 2021.
  • Surgeries conducted in the specified tertiary referral hospital.
  • Patients who provided written informed consent for the surgical procedure and for the use of their personal data in scientific research.
  • Availability of medical records and videos of surgeries for data collection.
  • Patients who underwent surgery for one of the following conditions:
  • Deep infiltrating endometriosis (DIE)
  • Endometrial Cancer
  • Pelvic prolapse treated by laparoscopic surgical procedure
  • Single-port access laparoscopy for benign gynecological diseases
  • Surgeries performed by either senior surgeon (S.A.) or junior surgeon (M.N.D).

Exclusion

  • Surgeries conducted outside the timeframe of March 2019 to May 2021.
  • Surgeries not involving multiport or single-site-port laparoscopic surgery with pelvic organ suspension.
  • Patients who did not provide written informed consent.
  • Absence of medical records or surgery videos for data collection.
  • Surgeries not performed in the mentioned tertiary referral hospital.
  • Surgeries not primarily conducted for the specified indications (i.e., DIE, oncological disease, pelvic prolapse).
  • Surgeries not performed by the listed surgeons (S.A. or M.N.D).

Key Trial Info

Start Date :

March 1 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 30 2021

Estimated Enrollment :

330 Patients enrolled

Trial Details

Trial ID

NCT06187558

Start Date

March 1 2019

End Date

May 30 2021

Last Update

January 2 2024

Active Locations (1)

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1

Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy

Monserrato, Cagliari, Italy, 09042