Closure of the Uterine Artery at Its Origin vs at the Cervix: a Randomized Trial

Laparoscopy Clinical Trial

Official title:

Closure at the Origin of the Uterine Artery vs. Closure at the Cervico-isthmic Level in Laparoscopic Hysterectomy: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156932
• Other study ID #: 440/CE
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2021
• Source: Ospedale degli Infermi di Biella
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• benign disease
• elective laparoscopic hysterectomy

Exclusion Criteria:

• malignant disease
• emergency laparoscopic hysterectomy

Related Conditions & MeSH terms

• Anatomy
• Hysterectomy
• Laparoscopy
• Uterine Artery

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale degli Infermi	Ponderano	Biella

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale degli Infermi di Biella

Country where clinical trial is conducted

Italy, 

References & 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;(8):CD003677. doi: 10.1002/14651858.CD003677.pub5. Review. — View Citation

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. — View Citation

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. — View Citation

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 Lap — View Citation

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.2013.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimated blood loss	ml	End of surgical procedure