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NCT Number: NCT06802198

A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes

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.

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Key information

Conditions

Fibroid Uterus Abnormal Uterine Bleeding Adenomyosis Benign Gynecologic Neoplasm Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Leiomyoma Metrorrhagia Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica

Rome, Lazio, 00168, Italy

Location contact

Giovanni Panico, MD

CONTACT

[email protected]

+390630153567

Giovanni Panico, MD

PRINCIPAL_INVESTIGATOR

Giovanni Scambia, Prof

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Postoperative pain

    Time frame: 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.

  2. Intra-operative data

    Time frame: 5 years

    To compare of operative time, estimated blood loss, associated procedures, and need for conversion to other techniques.

  3. intraoperative complications

    Time frame: 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.

  4. short and long-term postoperative complications

    Time frame: 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

  5. Urinary, bowel and pelvic floor symptoms

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Panico, MD

CONTACT

[email protected]

+390630153567

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial

Acronym: STORY

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jan 31, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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