Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy

Not Applicable

Not yet recruiting

• Conditions: Pelvic Organ Prolapse; Surgery; Gynecologic Disorders
• Interventions: Procedure: vaginal hysterectomy by bipolar vessels sealing; Procedure: vaginal hysterectomy by traditional technique

• Registration Number: NCT06220253
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Study Start: 2024-06
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Hysterectomy by bipolar coagulation technique	vaginal hysterectomy by bipolar vessels sealing	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.
Vaginal hysterectomy by traditional technique with reabsorbable stitches	vaginal hysterectomy by traditional technique	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.

Primary Outcome Measures

Name	Time	Method
Learning curve comparison	immediate post operative time	The primary objective of the study is to compare the learning curves (in terms of operating time, blood loss, intraoperative complications) for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women. The two procedures compared will be the traditional technique performed by applying reabsorbable sutures and the bipolar coagulation technique.

Secondary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of the two different techniques of vaginal hysterectomy.	3 days after the surgical procedure	Effectiveness will be assessed in terms of short-term outcomes such as: Intraoperative complications post-operative pain inpatient time Post-operative urinary infections vaginal infections, postoperative collected hematomas

Trial Locations

Locations (1)

Arianna Casiraghi; 🇮🇹 Milan, Italy