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

Ospedale degli Infermi di Biella

Status: Completed

Conditions: Anatomy; Laparoscopy; Uterine Artery; Hysterectomy

Treatments: Procedure: uterine artery closure

Study type: Interventional

Funder types: Other

Identifiers

NCT04156932

440/CE

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• benign disease
• elective laparoscopic hysterectomy

Exclusion criteria

• malignant disease
• emergency laparoscopic hysterectomy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

OUC

Active Comparator group

Description:

Origin uterine artery closure

Treatment:

Procedure: uterine artery closure

IUC

Active Comparator group

Description:

Cervical-isthmic uterine artery closure

Treatment:

Procedure: uterine artery closure