A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes (STORY)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

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

Treatments: Procedure: total hysterectomy; Procedure: subtotal hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06802198

6429

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

patients undergoing total hysterectomy

Active Comparator group

Description:

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

Treatment:

Procedure: total hysterectomy

patients undergoing subtotal hysterectomy

Experimental group

Description:

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

Treatment:

Procedure: subtotal hysterectomy