A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes

NCT ID: NCT06802198

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2030-02-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

patients undergoing total hysterectomy

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

Group Type: ACTIVE_COMPARATOR

total hysterectomy

Intervention Type: PROCEDURE

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

patients undergoing subtotal hysterectomy

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

Group Type: EXPERIMENTAL

subtotal hysterectomy

Intervention Type: PROCEDURE

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

Interventions

total hysterectomy

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

Intervention Type: PROCEDURE

subtotal hysterectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Panico, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica

Rome, Lazio, Italy

Countries

Italy

Central Contacts

Giovanni Panico, MD

Role: CONTACT

giovanni.panico@policlinicogemelli.it

+390630153567

Facility Contacts

Giovanni Panico, MD

Role: primary

giovanni.panico@policlinicogemelli.it

+390630153567

Other Identifiers

6429

Identifier Type: -

Identifier Source: org_study_id