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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03101098
Other study ID # 2017-02-001
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date April 10, 2017
Est. completion date March 1, 2020

Study information

Verified date April 2019
Source Kangbuk Samsung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized trial is aimed to investigate the role of retroperitoneal TLH in enlarge uterus.


Description:

Laparoscopic hysterectomy is one of the most common gynecologic surgeries worldwide. Generally, in total laparoscopic hysterectomy (TLH), uterine arteries are coagulated or transected close to the uterus, alongside the cervix, like surgical technique of a conventional total abdominal hysterectomy. Recently, several studies showed that ligation of uterine artery where it originates from the internal iliac artery during TLH (so-called "retroperitoneal TLH") is effective for reducing blood loss. However, the application of this technique to clinical practice have not been well investigated in terms of its efficacy and safety. Moreover, most of the previous studies on retroperitoneal TLH were small case series or retrospective comparative studies with conventional TLH. Therefore, the investigators conducted this randomized trial to investigate the role of retroperitoneal TLH in enlarge uterus.


Recruitment information / eligibility

Status Suspended
Enrollment 54
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria:

- absence of pregnancy at the time of presentation

- uterine volume between 12 and 18 weeks of gestation by pelvic examination

- appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

Exclusion Criteria:

- any suggestion of malignant uterine or adnexal diseases

- any major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance

- an inability to understand and provide written informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Retroperitoneal liagation of uterine artery
the site of ligation of uterine artery is the area that it originates from the internal iliac artery during TLH
Classical ligation of uterine artery
the site of ligation of uterine artery is the area alongside the cervix

Locations

Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operative blood loss Operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery. Operation day
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