A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH

This study has been completed.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Kathryn OKeeffe MD, Womens Care
ClinicalTrials.gov Identifier:
NCT01217866
First received: October 6, 2010
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Benign Uterine Disease
Procedure: Laparoscopic assisted vaginal hysterectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy

Resource links provided by NLM:


Further study details as provided by Womens Care:

Primary Outcome Measures:
  • Surgical time [ Time Frame: Operating room time in minutes ] [ Designated as safety issue: No ]
    The total time the subject spent in surgery was compared between the two groups

  • Estimated blood loss [ Time Frame: Blood loss during surgery in cc per minute ] [ Designated as safety issue: No ]
    The total blood loss in cc per minutes operating was compared between the two groups


Enrollment: 79
Study Start Date: August 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Surgical removal of uterus vaginally

Detailed Description:

79 women with benign uterine disease underwent laparoscopic assisted vaginal hysterectomy with or without bilateral salpingo-oophorectomy. Subjects charts were divided into two groups based on surgical technique and the following parameters were reviewed retrospectively: surgical time, blood loss, uterine weight, patient weight, patient age, post operative fever >100.4 F, readmission to hospital within one week, return to operating room within 24 hours, length of hospital stay, and blood transfusion. Group A, N=35 used traditional suture technique vaginally. Group B, N=44 used Enseal coagulation cutting device vaginally.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients who underwent Laparoscopically Assisted Vaginal Hysterectomy (LAVH)

Criteria

Inclusion Criteria:

  • none, observational study

Exclusion Criteria:

  • none, observational study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01217866

Sponsors and Collaborators
Womens Care
Ethicon Endo-Surgery
Investigators
Principal Investigator: Katie O'Keeffe, MD Glens Falls Hospital
  More Information

No publications provided

Responsible Party: Kathryn OKeeffe MD, MD, Womens Care
ClinicalTrials.gov Identifier: NCT01217866     History of Changes
Other Study ID Numbers: 1-44206615
Study First Received: October 6, 2010
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Womens Care:
laparoscopic
vaginal
hysterectomy

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014