4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial

NCT04637022 | Unknown

• 1 other identifier: DIPUSVSP-27-07-2088
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized trial aims to assess if the operative time of vaginal cuff suture performed by trainees could be reduced using 3D laparoscopy instead of 4K laparoscopy.

Conditions

Uterine Fibroid; Uterine Bleeding; Uterine Prolapse

Keywords

4k laparoscopy; 3d laparoscopy; surgeons in training

Outcome Measures

Primary Outcomes (1)

• operative time

  To compare the time taken to close the vaginal cuff, which was defined as time, starting from the initial grasp of the suture to cutting the suture, with 3D Laparoscopy vs 4K laparoscopy

  intra-operative

Secondary Outcomes (1)

• Intra-operative complications

  intra-operative

Other Outcomes (1)

• post-operative complications

  up to 3 months

Study Arms (2)

3D laparoscopy arm

Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 3D laparoscopic camera

4k laparoscopy arm

Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 4k laparoscopic camera

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and / or magnetic resonance and / or CT) and with indication for total laparoscopic hysterectomy with consequently need for laparoscopic suture of the vaginal cuff, will be enrolled in the study.

You may qualify if:

• Patients suffering from benign gynecological pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy and consequently need for laparoscopic suture of the vaginal cuff
• American Society of Anesthesiologists (ASA) class \< 3
• Patient's informed consent

You may not qualify if:

• Suspected neoplastic pathology
• Patients not eligible for surgery
• Actual pregnancies or pelvic inflammatory disease

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Rome, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Leiomyoma; Uterine Hemorrhage; Uterine Prolapse

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical

Central Study Contacts

Francesco Fanfani, Professor

CONTACT

06 30154979; francesco.fanfani74@gmail.com

Stefano Restaino, MD

CONTACT

restaino.stefano@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: November 19, 2020
• Study Start: January 25, 2021
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

IT (1)