NCT06802198

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
46mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Oct 2025Feb 2030

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

September 5, 2025

Status Verified

January 1, 2025

Enrollment Period

2.3 years

First QC Date

January 27, 2025

Last Update Submit

September 4, 2025

Conditions

Fibroid UterusMetrorrhagiaAdenomyosisBenign Gynecologic NeoplasmEndometriosisAbnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

  • Quality of life and patient's impression of improvement at 36 months after surgery

    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 Outcomes (5)

  • Postoperative pain

    5 years

  • Intra-operative data

    5 years

  • intraoperative complications

    5 years

  • short and long-term postoperative complications

    5 years

  • Urinary, bowel and pelvic floor symptoms

    5 years

Study Arms (2)

patients undergoing total hysterectomy

ACTIVE COMPARATOR

Total hysterectomy involves the complete removal of the uterus including the cervix

Procedure: total hysterectomy

patients undergoing subtotal hysterectomy

EXPERIMENTAL

Subtotal hysterectomy involves the removal of the upper part of the uterus preserving the cervix

Procedure: subtotal hysterectomy

Interventions

total hysterectomyPROCEDURE

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

patients undergoing total hysterectomy
subtotal hysterectomyPROCEDURE

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

patients undergoing subtotal hysterectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>18 years
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

LeiomyomaMetrorrhagiaAdenomyosisEndometriosis

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Giovanni Panico, MD

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Panico, MD

CONTACT

+390630153567giovanni.panico@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2030

Last Updated

September 5, 2025

Record last verified: 2025-01

Locations

IT(1)