A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06802198
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • total hysterectomy — PROCEDURE
    Total hysterectomy (TH) involves the complete removal of the uterus including the cervix
  • subtotal hysterectomy — PROCEDURE
    subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus

Study Details

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.

Key Dates

First listed
Jan 31, 2025
Start date
Oct 1, 2025
Status verified
Jan 2025
Primary completion
Feb 1, 2028
Completion
Feb 1, 2030

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: patients undergoing total hysterectomy
    Total hysterectomy 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

Primary Outcome Measure

Quality of life and patient's impression of improvement at 36 months after surgery [ Time Frame: 5 years ]

Central Contacts

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