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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Organ Prolapse; Surgery; Gynecologic Disorders
• Intervention / Treatment: Procedure: vaginal hysterectomy by bipolar vessels sealing; Procedure: vaginal hysterectomy by traditional technique

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arianna Casiraghi, MD; Phone Number: 3482400195; Email: casiraghi.arianna@hsr.it
• Study Contact Backup: Name: Stefano Salvatore, MD; Email: salvatore.stefano@hsr.it

Study Locations

• Italy
  • Milan, Italy, 20159
    • Arianna Casiraghi
    • Contact: Arianna Casiraghi, MD; Phone Number: 3482400195
    • Principal Investigator: stefano salvatore, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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
Other: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Stefano Salvatore, MD, San Raffaele Hospital, Milan

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pelvic organ prolapse; urogynecologic surgery; learning curve; bipolar vessels sealing
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Prolapse; Pelvic Organ Prolapse; Genital Diseases, Female
• Other Study ID Numbers: LEACURV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No