Clinical trial NCT06220253: Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy
Official title: Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy: Traditional Versus Minimally Invasive Bipolar Coagulation Technique
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Gynecologic Disorders
Surgery
Keywords: pelvic organ prolapse
urogynecologic surgery
learning curve
bipolar vessels sealing
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1 in two groups:

1. Study group: bipolar coagulation technique
2. Comparison group: reabsorbable stitches
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Learning curve comparison
timeFrame: immediate post operative time
Secondary outcomes:
measure: Evaluate the effectiveness of the two different techniques of vaginal hysterectomy.
timeFrame: 3 days after the surgical procedure
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Arianna Casiraghi
Study officials:
affiliation: San Raffaele Hospital, Milan
name: Stefano Salvatore, MD
role: PRINCIPAL_INVESTIGATOR
References: