Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy

NCT06220253 | Not Yet Recruiting DMC

• 1 other identifier: LEACURV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Gynecologic Disorders; Surgery

Keywords

pelvic organ prolapse; urogynecologic surgery; learning curve; bipolar vessels sealing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the effectiveness of the two different techniques of vaginal hysterectomy.

  3 days after the surgical procedure

Study Arms (2)

Vaginal Hysterectomy by bipolar coagulation technique

OTHER

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

Vaginal hysterectomy by traditional technique with reabsorbable stitches

OTHER

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

Interventions

vaginal hysterectomy by bipolar vessels sealing PROCEDURE

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 bipolar coagulation technique

vaginal hysterectomy by traditional technique PROCEDURE

The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be sutured by absorbable threads

Vaginal hysterectomy by traditional technique with reabsorbable stitches

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Arianna Casiraghi

Milan, 20159, Italy

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Stefano Salvatore, MD

  San Raffaele Hospital, Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arianna Casiraghi, MD

CONTACT

3482400195; casiraghi.arianna@hsr.it

Stefano Salvatore, MD

CONTACT

salvatore.stefano@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized 1:1 in two groups: 1. Study group: bipolar coagulation technique 2. Comparison group: reabsorbable stitches

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: January 23, 2024
• Study Start: June 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

IT (1)