Trials Sponsors Conditions Drugs Pricing

Conditions

Benign or Preinvasive Uterine Disease

Keywords

LESSBenign uterine diseaseLAVH

Outcome Measures

Primary Outcomes (1)

postoperative hospital stay
The primary endpoint was to compare average length of postoperative hospital stay and the ratio of patients discharged within 2 days after surgery between LESS and conventional groups.
within 1 week after surgery

Secondary Outcomes (5)

postoperative pain
within 1 week after surgery
postoperative analgesics requirement
within 1 week after surgery
operating time
1 day (immediately ater surgery)
Transfusion requirement and amount
within 1 week after surgery
intra and postoperative complication
within 1 months after surgery

Study Arms (2)

Single-port LAVH group

EXPERIMENTAL

single-port laparoscopic assisted vaginal hysterectomy

Procedure: Single-port LAVH

Three-port LAVH group

ACTIVE COMPARATOR

three-port laparoscopic assisted vaginal hysterectomy

Procedure: Three-port LAVH

Interventions

Single-port LAVHProcedure

LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.

Single-port LAVH group

Three-port LAVHProcedure

Conventional LAVH was performed using three ports; a 12, 10, and 5-mm port was placed in the umbilicus, left lower quadrant, and suprapubic area, respectively. A rigid, 0-degree, 12 mm laparoscope was introduced through 12mm port of umbilicus.

Eligibility Criteria

Age20 Years - 70 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient who undergo laparoscopic assisted vaginal hysterectomy due to following gynecologic disease
uterine leiomyoma

Sponsors & Collaborators

Asan Medical Center
Otherlead

Study Sites (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

Related Publications (1)

Kang OJ, Nam JH, Park JY. Comparison of single-site and three-port hysterectomy for benign uterine diseases: A randomised trial (LESS-H). Eur J Obstet Gynecol Reprod Biol. 2025 Apr 17;308:251-256. doi: 10.1016/j.ejogrb.2025.03.005. Epub 2025 Mar 10.
PMID: 40088545DERIVED

Study Officials

Joo-Hyun Nam, M.D., Ph.D.
Asan Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

424 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 6, 2012

Study Start

November 23, 2012

Actual (reported)

Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Single-port LAVH group

Three-port LAVH group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Single-port LAVH group

Three-port LAVH group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations