Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction
A Partners Prospective Study Assessing the Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction
1 other identifier
observational
70
1 country
3
Brief Summary
The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2016
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2015
CompletedFirst Posted
Study publicly available on registry
July 14, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJanuary 25, 2019
January 1, 2019
1.4 years
July 9, 2015
January 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Return to daily activities
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).
assessed between 2 and 6 weeks after surgery (at post-op visit)
Secondary Outcomes (3)
OR Time
At the time of surgery
Estimated Blood Loss
At the time of surgery
Spillage of the morcellated tissue or fluids in the abdomen and pelvis
At the time of surgery
Study Arms (2)
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.
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.
Eligibility Criteria
70 adult women scheduled to undergo a laparoscopic hysterectomy
You may qualify if:
- years of age or greater
- eligible to undergo laparoscopic Hysterectomy, as determined clinically by the operating surgeon
You may not qualify if:
- suspected malignancy
- medical illness precluding laparoscopy
- inability to give informed consent
- allergy to indigo carmine or methylene blue dye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Massachusetts General Hospitalcollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Faulkner Hospital
Boston, Massachusetts, 02130, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jon I Einarsson, MD, PhD, MPH
Brigham and Women's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Division of Minimally Invasive Gynecology
Study Record Dates
First Submitted
July 9, 2015
First Posted
July 14, 2015
Study Start
April 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
January 25, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share