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

NCT03101098 | Suspended

• 1 other identifier: 2017-02-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Retroperitoneal hysterectomy

EXPERIMENTAL

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

Classical hysterectomy

ACTIVE COMPARATOR

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

Interventions

Retroperitoneal liagation of uterine artery PROCEDURE

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

Retroperitoneal hysterectomy

Classical ligation of uterine artery PROCEDURE

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

Classical hysterectomy

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

Study Officials

• Taejong Song, MD PhD

  Kangbuk Samsung Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 4, 2017
• Study Start: April 10, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)