NCT01564602

Brief Summary

The main objective of this trial is to assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The operative time, weight of the uterus, blood loss and hospital stay will be record, respectively. The pain score is based on the visual analogue scale in which patients record the intensity of their pain 12, 24, and 48 hours after surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

3 years

First QC Date

February 20, 2012

Last Update Submit

March 28, 2012

Conditions

MyomaAdenomyosis

Keywords

2-channel single port laparoscopymultiple-channel port laparoscopy

Outcome Measures

Primary Outcomes (1)

  • The operative time

    We will follow the patients until one month after the surgery. The primary outcome measure of this trial is the effect and safety of single port-access laparoscopic-assisted vaginal hysterectomy.

    We will follow the patients until one month after the surgery.

Secondary Outcomes (4)

  • weight of the uterus

    one month

  • blood loss

    one month

  • hospital length of stay

    one month

  • morbidity

    one month

Study Arms (1)

single port laparoscopic surgery

EXPERIMENTAL

2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders

Device: comparison multiple channel port laparoscopic surgery

Interventions

comparison multiple channel port laparoscopic surgeryDEVICE

to compare 2-channel single port and multiple channel port laparoscopic surgery

Also known as: multiple channel port laparoscopic surgery
single port laparoscopic surgery

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)
  • American Society of Anesthesiologists (ASA) physical status of patient: classification I-II

You may not qualify if:

  • The procedure will be required to conversion to laparotomy.
  • Any cardio-vascular diseases.
  • Malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 1121, Taiwan

RECRUITING

MeSH Terms

Conditions

MyomaAdenomyosis

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Yi-Jen Chen, PHD

    Taipei Veterans General Hospital, Taiwan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 20, 2012

First Posted

March 28, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2014

Study Completion

December 1, 2014

Last Updated

April 2, 2012

Record last verified: 2012-03

Locations

TW(1)