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

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.

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Key information

Conditions

Benign Uterine Disease

Age range

35 year–75 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

none, observational study

Exclusion criteria

none, observational study

Treatment and study plan

Laparoscopic assisted vaginal hysterectomy

Procedure

Surgical removal of uterus vaginally

Primary outcomes

Surgical time

Time frame: Operating room time in minutes

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

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

Sponsors and collaborators

Lead sponsor

Womens Care

Other

Collaborators

Ethicon Endo-Surgery

Registry information

Official study title

A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Oct 8, 2010
Registry last updated: Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed