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

NCT ID: NCT03101098

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2020-03-01

Brief Summary

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

Detailed 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.

Conditions

Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Retroperitoneal hysterectomy

In subjects allocated to the experimental group, which the uterine vessels were ligated where it originates from the internal iliac artery,

Group Type: EXPERIMENTAL

Retroperitoneal liagation of uterine artery

Intervention Type: PROCEDURE

the site of ligation of uterine artery is the area that it originates from the internal iliac artery during TLH

Classical hysterectomy

The operative technique of classical total laparoscopic hysterectomy (TLH) performed in the control group was comparable to that of retroperitoneal TLH, except for one that coagulation and transection of uterine artery was achieved using an energy device alongside the cervix

Group Type: ACTIVE_COMPARATOR

Classical ligation of uterine artery

Intervention Type: PROCEDURE

the site of ligation of uterine artery is the area alongside the cervix

Interventions

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

Intervention Type: PROCEDURE

Classical ligation of uterine artery

the site of ligation of uterine artery is the area alongside the cervix

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kangbuk Samsung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taejong Song

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taejong Song, MD PhD

Role: STUDY_CHAIR

Kangbuk Samsung Hospital

Locations

Kangbuk Samsung Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2017-02-001

Identifier Type: -

Identifier Source: org_study_id