Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT04156932
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2019-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closure of the Uterine Artery at Its Origin vs at the Cervix: a Randomized Trial
Sponsor:
Ospedale degli Infermi di Biella
Organization:
Study Overview
Official Title:
Closure at the Origin of the Uterine Artery vs. Closure at the Cervico-isthmic Level in Laparoscopic Hysterectomy: a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: