A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes (STORY)

Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial

The goal of this randomized clinical trial is to assess the outcomes of total laparoscopic hysterectomy vs subtotal laparoscopic hysterectomy + mini-laparotomy for uterine extraction for benign gynecological conditions in terms of change in quality of life at 36 months after surgery and patient's impression of improvement. The secondary objectives of the study are to assess any differences in terms of peri and postoperative outcomes (postoperative pain, blood loss, hospital stay, intraoperative or short and long-term postoperative complications, long term urinary, bowel and pelvic floor symptoms, prevalence of vaginal cuff dehiscence).

Participants will fill the following questionnaires pre-operatively and at the follow up:

  • Short Form 36 (SF36),
  • Euro Quality of life 5D-3L (EQ 5D-3L)
  • Female Sexual Function Index (FSFI)
  • Patient Global Impression of Improvement (PGI-I) only during the follow-up period.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

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

Study Locations

    • Lazio
      • Roma, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica
        • Contact:
        • Principal Investigator:
          • Giovanni Panico, MD
        • Sub-Investigator:
          • Giovanni Scambia, Prof

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age>18 years
  • Signed informed consent

Exclusion Criteria:

  • Uterine or adnexal pathology suspect for malignancy
  • Abnormal or unknown PAP test
  • Patients with invasive neoplasia in the previous 5 years (excluding non-melanoma skin tumors, breast cancer T1 N0 M0 Grade 1 or 2 without signs of recurrence or activity).
  • Previous radical pelvic surgery or radiotherapy;
  • Age > 80 years
  • Pregnant patients
  • Desire for further pregnancies
  • Contraindications to general anaesthesia or to the Trendelenburg position
  • Refusal to sign informed consent

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: patients undergoing total hysterectomy
Total hysterectomy involves the complete removal of the uterus including the cervix
Total hysterectomy (TH) involves the complete removal of the uterus including the cervix
Experimental: patients undergoing subtotal hysterectomy
Subtotal hysterectomy involves the removal of the upper part of the uterus preserving the cervix
subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life and patient's impression of improvement at 36 months after surgery
Time Frame: 5 years
To assess the impact of surgery on patients' quality of life measured by the Physical Functioning items of SF36 questionnaire, at 36 months after surgery
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 5 years
Post-operative pain will be evaluated using the visual analog scale (VAS) score, every 6 hours from the end of surgery, up to 48 hours.
5 years
Intra-operative data
Time Frame: 5 years
To compare of operative time, estimated blood loss, associated procedures, and need for conversion to other techniques.
5 years
intraoperative complications
Time Frame: 5 years
To evaluate the occurrence of intraoperative complications according to the modified Satava classification system. Grade 1 complications include incidents without consequences for the patient; grade 2 complications, which are treated intraoperatively with endoscopic surgery (grade 2a) or required endoscopic re-treatment (grade 2b); and grade 3 complications include incidents requiring open or laparoscopic surgery.
5 years
short and long-term postoperative complications
Time Frame: 5 years
To evaluate the occurrence of postoperative complications according to the Clavien-Dindo classification and to evaluate the occurrence of long-term complications, including vaginal cuff dehiscence, up to 36 months post-operatively
5 years
Urinary, bowel and pelvic floor symptoms
Time Frame: 5 years
To evaluate the impact of surgery on other urinary and bowel symptoms, with particular attention to 'de novo' symptoms, and long-term occurrence of pelvic organ prolapse or pelvic floor dysfunction.
5 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Giovanni Panico, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

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 (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Estimated)

January 31, 2025

Study Record Updates

Last Update Posted (Estimated)

January 31, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

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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