NCT06220253

Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy

Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy: Traditional Versus Minimally Invasive Bipolar Coagulation Technique

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	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
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

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-01-23
• Last updated: 2024-05-21

Locations

1 site across 1 country: Italy