NCT02496130

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

• Hysterectomy

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2015-07-14
• Last updated: 2019-01-25

Locations

3 sites across 1 country: United States