A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06802198
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Study Start: 2025-02-01
• Primary Completion: 2028-02-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life and patient's impression of improvement at 36 months after surgery	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

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	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.
Intra-operative data	5 years	To compare of operative time, estimated blood loss, associated procedures, and need for conversion to other techniques.
intraoperative complications	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.
short and long-term postoperative complications	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
Urinary, bowel and pelvic floor symptoms	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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica; 🇮🇹 Roma, Lazio, Italy