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

Kangbuk Samsung Hospital

Status: Suspended

Conditions: Hysterectomy

Treatments: Procedure: Classical ligation of uterine artery; Procedure: Retroperitoneal liagation of uterine artery

Study type: Interventional

Funder types: Other

Identifiers

NCT03101098

2017-02-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 estimated patients

Sex: Female

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Retroperitoneal hysterectomy

Experimental group

Description:

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

Treatment:

Procedure: Retroperitoneal liagation of uterine artery

Classical hysterectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Classical ligation of uterine artery