Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06220253
• Other study ID #: LEACURV
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: IRCCS San Raffaele
• Contact: Arianna Casiraghi, MD
• Phone: 3482400195
• Email: casiraghi.arianna[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disorders
• Pelvic Organ Prolapse
• Prolapse
• Surgery

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	Arianna Casiraghi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Learning curve comparison	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.	immediate post operative time
Secondary	Evaluate the effectiveness of the two different techniques of vaginal hysterectomy.	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	3 days after the surgical procedure