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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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03101098
Enrollment
54
Registered
2017-04-04
Start date
2017-04-10
Completion date
2020-03-01
Last updated
2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy

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.

Interventions

PROCEDURERetroperitoneal liagation of uterine artery

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

PROCEDUREClassical ligation of uterine artery

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

Sponsors

Kangbuk Samsung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Operative blood lossOperation dayOperative 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026