NCT01217866

Brief Summary

Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic portion of the case used an EN\~SEAL device to Group B - the laparoscopic BSO was done using a 3mm EN-SEAL device through 2 lateral 5mm ports.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Status
completed

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

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

6 months

First QC Date

October 6, 2010

Last Update Submit

December 19, 2012

Conditions

Benign Uterine Disease

Keywords

laparoscopicvaginalhysterectomy

Outcome Measures

Primary Outcomes (2)

  • Surgical time

    The total time the subject spent in surgery was compared between the two groups

    Operating room time in minutes

  • Estimated blood loss

    The total blood loss in cc per minutes operating was compared between the two groups

    Blood loss during surgery in cc per minute

Study Arms (1)

LAVH, techniques

Women aged 35-75 who underwent laparoscopic assisted vaginal hysterectomy via either suture technique vaginally or Enseal coagulation cutting device vaginally

Procedure: Laparoscopic assisted vaginal hysterectomy

Interventions

Laparoscopic assisted vaginal hysterectomyPROCEDURE

Surgical removal of uterus vaginally

LAVH, techniques

Eligibility Criteria

Age35 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent Laparoscopically Assisted Vaginal Hysterectomy (LAVH)

You may qualify if:

  • none, observational study

You may not qualify if:

  • none, observational study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Katie O'Keeffe, MD

    Glens Falls Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 8, 2010

Study Start

August 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

December 20, 2012

Record last verified: 2012-12