Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy

NCT ID: NCT06220253

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-03-31

Brief Summary

Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures.

Detailed Description

This is a prospective, randomized, spontaneous monocentric interventional study on a procedure in which 60 female patients will be enrolled with a diagnosis of pelvic organs prolapse which are eligible for vaginal hysterectomy. The data relating to the intervention will be collected, analyzed and compared through a descriptive statistics.

Patients will be randomized 1:1 in two groups:

1. Study group: bipolar coagulation technique

2. Comparison group: reabsorbable stitches The primary outcome of the study is to compare the learning curves for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women.

Secondary outcomes are to evaluate the effectiveness of the two different procedures through the evaluation of short-term outcomes for both procedures under consideration.

The planned duration of recruitment will be 7 months. In this period of time it is planned to enrol a total of 60 patients. Once the learning curve plateau has been reached for both procedures, the study will be considered finished. The number of samples was chosen on the basis of the feasibility of recruitment and the possibility of evaluating the learning curve of the operators.

Conditions

Pelvic Organ Prolapse; Gynecologic Disorders; Surgery

Study Design

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

Study Groups

Vaginal Hysterectomy by bipolar coagulation technique

The surgery will take place according to the canonical times of vaginal hysterectomy, after incision of the portio, detachment of the bladder-vaginal fascia and vaginal rectum, opening of the anterior and posterior peritoneum, taking, section and ligament of the ligaments uterus-sacral ligaments, and subsequent coagulation by bipolar instrument of the other structures of the uterus and their section, in particular of the uterine arteries, tubes, uterine-ovarian ligaments and round ligament bilaterally.

Group Type: OTHER

vaginal hysterectomy by bipolar vessels sealing

Intervention Type: PROCEDURE

The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be coagulated and cut by a bipolar vessel sealing instrument

Vaginal hysterectomy by traditional technique with reabsorbable stitches

The surgery will take place according to the canonical times of vaginal hysterectomy, after incision of the port, detachment of the bladder-vaginal fascia and vaginal rectum, opening of the anterior and posterior peritoneum, taking and suturing with absorbable threads of all the support structures of the uterus, in particular uterus-sacral ligaments, uterine arteries, tubes, uterine-ovarian ligaments and round ligament bilaterally.

Group Type: OTHER

vaginal hysterectomy by traditional technique

Intervention Type: PROCEDURE

The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be sutured by absorbable threads

Interventions

vaginal hysterectomy by bipolar vessels sealing

The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be coagulated and cut by a bipolar vessel sealing instrument

Intervention Type: PROCEDURE

vaginal hysterectomy by traditional technique

The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be sutured by absorbable threads

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women aged >18 years
• Genital prolapse > II degree in accordance with the "POP-Q System" eligible for vaginal hysterectomy
• Understanding and signing of informed consent for surgical procedure

Exclusion Criteria

• Need for simultaneous bilateral adnexectomy
• Previous cesarian section
• Patients with abdominal laparoscopic or laparotomy history
• Patients with malignant pathology and/or adnexal pathology
• Confirmed or presumed pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Stefano Salvatore

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Salvatore, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Hospital, Milan

Locations

Arianna Casiraghi

Milan, , Italy

Countries

Italy

Central Contacts

Arianna Casiraghi, MD

Role: CONTACT

casiraghi.arianna@hsr.it

3482400195

Stefano Salvatore, MD

Role: CONTACT

salvatore.stefano@hsr.it

Facility Contacts

Arianna Casiraghi, MD

Role: primary

3482400195

Other Identifiers

LEACURV

Identifier Type: -

Identifier Source: org_study_id