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A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes

NCT06802198 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Fibroid Uterus
  • Metrorrhagia
  • Adenomyosis
  • Benign Gynecologic Neoplasm
  • Endometriosis
  • Abnormal Uterine Bleeding

Interventions

PROCEDURE

total hysterectomy

Total hysterectomy (TH) involves the complete removal of the uterus including the cervix

PROCEDURE

subtotal hysterectomy

subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Giovanni Panico, MD · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2028-02-01
Completion
2030-02-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06802198 on ClinicalTrials.gov