NCT04156932

Brief Summary

One of the fundamental surgical steps in patients undergoing laparoscopic hysterectomy is the closure of the uterine artery, this vessel provides the greatest blood supply to the uterus. This step can be done in two ways: the surgeon can choose to interrupt the blood flow by closing the uterine artery in its last part, close to the uterus, or the surgeon can develop the anatomical spaces around the uterus into the deep pelvis, closing it to its origin, maintaining a minimally invasive approach in both cases. Scientific research has tried to establish whether one of the two modalities is the best in reducing intraoperative blood loss and possible complications, but currently there is not enough evidence to recommend an approach rather than another. The investigator has therefore decided to evaluate the results at the end of a laparoscopic hysterectomy in a scientifically rigorous manner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

November 6, 2019

Last Update Submit

February 5, 2021

Conditions

AnatomyLaparoscopyUterine ArteryHysterectomy

Outcome Measures

Primary Outcomes (1)

  • estimated blood loss

    ml

    End of surgical procedure

Study Arms (2)

OUC

ACTIVE COMPARATOR

Origin uterine artery closure

Procedure: uterine artery closure

IUC

ACTIVE COMPARATOR

Cervical-isthmic uterine artery closure

Procedure: uterine artery closure

Interventions

uterine artery closurePROCEDURE

Interruption the uterine blood flow by closing the uterine artery at its cervical-isthmic part or at its origin.

IUCOUC

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • benign disease
  • elective laparoscopic hysterectomy

You may not qualify if:

  • malignant disease
  • emergency laparoscopic hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale degli Infermi

Ponderano, Biella, 13875, Italy

Location

Related Publications (5)

  • Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.

    PMID: 26264829RESULT

  • Aust T, Reyftmann L, Rosen D, Cario G, Chou D. Anterior approach to laparoscopic uterine artery ligation. J Minim Invasive Gynecol. 2011 Nov-Dec;18(6):792-5. doi: 10.1016/j.jmig.2011.07.008.

    PMID: 22024265RESULT

  • Simpson NA, Nimrod C, De Vermette R, Leblanc C, Fournier J. Sonographic evaluation of intervillous flow in early pregnancy: use of echo-enhancement agents. Ultrasound Obstet Gynecol. 1998 Mar;11(3):204-8. doi: 10.1046/j.1469-0705.1998.11030204.x.

    PMID: 9589145RESULT

  • Uccella S, Cromi A, Casarin J, Bogani G, Serati M, Gisone B, Pinelli C, Fasola M, Ghezzi F. Minilaparoscopic versus standard laparoscopic hysterectomy for uteri >/= 16 weeks of gestation: surgical outcomes, postoperative quality of life, and cosmesis. J Laparoendosc Adv Surg Tech A. 2015 May;25(5):386-91. doi: 10.1089/lap.2014.0478. Epub 2015 Apr 3.

    PMID: 25839384RESULT

  • Uccella S, Cromi A, Serati M, Casarin J, Sturla D, Ghezzi F. Laparoscopic hysterectomy in case of uteri weighing >/=1 kilogram: a series of 71 cases and review of the literature. J Minim Invasive Gynecol. 2014 May-Jun;21(3):460-5. doi: 10.1016/j.jmig.2013.08.706. Epub 2013 Sep 4.

    PMID: 24012921RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 8, 2019

Study Start

December 1, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)