- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06802198
A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes (STORY)
Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Giovanni Panico, MD
- Phone Number: +390630153567
- Email: giovanni.panico@policlinicogemelli.it
Study Locations
-
-
Lazio
-
Roma, Lazio, Italy, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica
-
Contact:
- Giovanni Panico, MD
- Phone Number: +390630153567
- Email: giovanni.panico@policlinicogemelli.it
-
Principal Investigator:
- Giovanni Panico, MD
-
Sub-Investigator:
- Giovanni Scambia, Prof
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: patients undergoing total hysterectomy
Total hysterectomy involves the complete removal of the uterus including the cervix
|
Total hysterectomy (TH) involves the complete removal of the uterus including the cervix
|
Experimental: patients undergoing subtotal hysterectomy
Subtotal hysterectomy involves the removal of the upper part of the uterus preserving the cervix
|
subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
Intra-operative data
Time Frame: 5 years
|
To compare of operative time, estimated blood loss, associated procedures, and need for conversion to other techniques.
|
5 years
|
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.
|
5 years
|
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 years
|
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.
|
5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Giovanni Panico, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Connective Tissue Diseases
- Neoplasms by Histologic Type
- Uterine Diseases
- Genital Diseases, Female
- Hemorrhage
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Connective Tissue
- Neoplasms, Muscle Tissue
- Uterine Hemorrhage
- Adenomyosis
- Genital Neoplasms, Female
- Endometriosis
- Leiomyoma
- Myofibroma
- Metrorrhagia
Other Study ID Numbers
- 6429
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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