NCT04209036

Brief Summary

Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 17, 2019

Last Update Submit

December 20, 2019

Conditions

Uterine FibroidUterine BleedingUterine Prolapse

Keywords

3D laparoscopy2D laparoscopysurgeons in training

Outcome Measures

Primary Outcomes (1)

  • Operative time

    To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy

    intra-operative

Secondary Outcomes (2)

  • Intra-operative complications

    intra-operative

  • Early post-operative complications

    from surgery up to 30 days from surgery

Study Arms (2)

3D laparoscopy arm

patients submitted to total hysterectomy using a 3D laparoscopic camera

Other: 0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)

2D laparoscopy arm

patients submitted to total hysterectomy using a 2D laparoscopic camera (standard laparoscopic camera)

Interventions

0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)OTHER

total laparoscopic hysterectomy using a 3D laparoscopy high-definition system

3D laparoscopy arm

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients suffering from benign uterine pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy
  • Uterine size \</= than 15 cm
  • American Society of Anesthesiologists (ASA) class \< 3
  • Patient's informed consent
  • No actual pregnancies or pelvic inflammatory disease
  • No previous major abdominal surgical procedures

You may not qualify if:

  • Suspected neoplastic pathology
  • Patients not eligible for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Rome, RM, 00168, Italy

RECRUITING

Related Publications (1)

  • Restaino S, Vargiu V, Rosati A, Bruno M, Dinoi G, Cola E, Moroni R, Scambia G, Fanfani F. 4K versus 3D total laparoscopic hysterectomy by resident in training: a prospective randomised trial. Facts Views Vis Obgyn. 2021 Sep;13(3):221-229. doi: 10.52054/FVVO.13.3.027.

    PMID: 34555876DERIVED

MeSH Terms

Conditions

LeiomyomaUterine HemorrhageUterine Prolapse

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPelvic Organ ProlapseProlapsePathological Conditions, Anatomical

Study Officials

  • Francesco Fanfani, Professor

    Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Fanfani, Professor

CONTACT

06 30154979francesco.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

December 17, 2019

First Posted

December 23, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

December 23, 2019

Record last verified: 2019-12

Locations

IT(1)