Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Operative blood loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Retroperitoneal hysterectomy
In subjects allocated to the experimental group, which the uterine vessels were ligated where it originates from the internal iliac artery,
Intervention: Retroperitoneal liagation of uterine artery (Procedure)
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
Intervention: Classical ligation of uterine artery (Procedure)
Outcomes
Primary Outcomes
Operative blood loss
Time Frame: Operation day
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Taejong Song
Professor
Kangbuk Samsung Hospital