Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy (LAST-1)

October 31, 2022 updated by: Antonio Simone Laganà, University of Palermo

Evaluation of Long-term Sexual Dysfunctions, Urinary Dysfunctions and Pelvic Organ Prolapse in Women Who Underwent Laparoscopic Subtotal Versus Total Hysterectomy for Benign Conditions

Hysterectomy is one of the most commonly performed gynecologic surgeries in the USA. It is used for many benign conditions such as leiomyoma and abnormal uterine bleeding. Surgery may involve the removal of the cervix (total hysterectomy, TH) or its preservation (supracervical or subtotal hysterectomy, SH). Whether TH or SH is the best procedure for benign conditions is a matter of debate. Considering the lack of evidence, this study aims to evaluate long-term sexual dysfunctions, urinary dysfunctions and pelvic organ prolapse in women who underwent laparoscopic subtotal versus total hysterectomy for benign conditions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions

Description

Inclusion Criteria:

  • Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions.

Exclusion Criteria:

  • Women with gynecological and non-gynecological cancers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subtotal Laparoscopic Hysterectomy
Women who underwent subtotal laparoscopic hysterectomy
Procedure: Subtotal Laparoscopic Hysterectomy
Subtotal laparoscopic hysterectomy involves removing the main body of the uterus and leaving the cervix in place by laparoscopy.
Total Laparoscopic Hysterectomy
Women who underwent total laparoscopic hysterectomy
Procedure: Total Laparoscopic Hysterectomy
Total laparoscopic hysterectomy involves removing the whole uterus and cervix by laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Dysfunctions
Time Frame: 5 years after surgery
Female Sexual Function Index
5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Dysfunctions
Time Frame: 5 years after surgery
Pelvic Floor Distress Inventory short form
5 years after surgery
Pelvic Organ Prolapse
Time Frame: 5 years after surgery
Pelvic Organ Prolapse (POP-Q) evaluation
5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Investigators

  • Principal Investigator: Antonio Simone Laganà, M.D., Ph.D., University of Palermo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2024

Primary Completion (Anticipated)

July 1, 2026

Study Completion (Anticipated)

July 1, 2028

Study Registration Dates

First Submitted

June 12, 2022

First Submitted That Met QC Criteria

June 12, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LAST-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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