Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction

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

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-09-30

Brief Summary

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The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery.

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Detailed Description

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The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery, including vaginal extraction and mini-laparotomy; both performed within a containment system. The primary aim is to assess return to normal daily activities after each of the surgical techniques. Return to daily activities will be recorded on a post-operative patient activity diary recording the following tasks: a) work (if applicable), b) domestic tasks, c) driving a vehicle (if applicable) and d) physical exercise (if applicable). Additional information regarding post-operative pain (measured on a Likert scale), potential complications of each technique, such as tearing of the bag or leakage, and peri- and post-operative outcomes will be collected. In order to aid in detection of leakage, blue dye (either indigo carmine or methylene blue) will be added to the containment bag prior to morcellation.

Conditions

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Hysterectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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minilaparotomy

Subjects in this group will have tissue (uterus) extracted via mini-laparotomy incision with knife morcellation. Morcellation will be performed within a containment system. Method of extraction/group assignment will be determined clinically by the operating surgeon based on patient characteristics and patient preference.

No interventions assigned to this group

vaginal extraction

Subjects in this group will have tissue (uterus) extracted via vaginal extraction with knife morcellation. Morcellation will be performed within a containment system. Method of extraction/group assignment will be determined clinically by the operating surgeon based on patient characteristics and patient preference.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or greater
* eligible to undergo laparoscopic Hysterectomy, as determined clinically by the operating surgeon

Exclusion Criteria

* suspected malignancy
* medical illness precluding laparoscopy
* inability to give informed consent
* allergy to indigo carmine or methylene blue dye

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No