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

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

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

Study Overview

• Status: Suspended
• Conditions: Hysterectomy
• Intervention / Treatment: Procedure: Retroperitoneal liagation of uterine artery; Procedure: Classical ligation of uterine artery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-746
    • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Retroperitoneal hysterectomy; In subjects allocated to the experimental group, which the uterine vessels were ligated where it originates from the internal iliac artery,	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
Active Comparator: 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	Procedure: Classical ligation of uterine artery; the site of ligation of uterine artery is the area alongside the cervix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Investigators: Study Chair: Taejong Song, MD PhD, Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017-02-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No