Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus

Hysterectomy Clinical Trial

Official title:

Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus: A Randomized Controlled Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03101098
• Other study ID #: 2017-02-001
• Status: Suspended
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hysterectomy

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