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

NCT ID: NCT01217866

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Benign Uterine Disease

Keywords

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laparoscopic vaginal hysterectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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LAVH, techniques

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

Laparoscopic assisted vaginal hysterectomy

Intervention Type PROCEDURE

Surgical removal of uterus vaginally

Interventions

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Laparoscopic assisted vaginal hysterectomy

Surgical removal of uterus vaginally

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* none, observational study

Exclusion Criteria

* none, observational study
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery

INDUSTRY

Sponsor Role collaborator

Womens Care

OTHER

Sponsor Role lead

Responsible Party

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Kathryn OKeeffe MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katie O'Keeffe, MD

Role: PRINCIPAL_INVESTIGATOR

Glens Falls Hospital

Other Identifiers

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1-44206615

Identifier Type: -

Identifier Source: org_study_id