Closure of the Uterine Artery at Its Origin vs at the Cervix: a Randomized Trial
NCT ID: NCT04156932
Last Updated: 2021-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2019-12-01
2020-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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OUC
Origin uterine artery closure
uterine artery closure
Interruption the uterine blood flow by closing the uterine artery at its cervical-isthmic part or at its origin.
IUC
Cervical-isthmic uterine artery closure
uterine artery closure
Interruption the uterine blood flow by closing the uterine artery at its cervical-isthmic part or at its origin.
Interventions
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uterine artery closure
Interruption the uterine blood flow by closing the uterine artery at its cervical-isthmic part or at its origin.
Eligibility Criteria
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Inclusion Criteria
* elective laparoscopic hysterectomy
Exclusion Criteria
* emergency laparoscopic hysterectomy
18 Years
85 Years
FEMALE
No
Sponsors
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Ospedale degli Infermi di Biella
OTHER
Responsible Party
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Locations
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Ospedale degli Infermi
Ponderano, Biella, Italy
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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440/CE
Identifier Type: -
Identifier Source: org_study_id
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