Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction

Completed

• Conditions: Hysterectomy

• Registration Number: NCT02496130
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Study Start: 2016-04
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Return to daily activities	assessed between 2 and 6 weeks after surgery (at post-op visit)	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).

Secondary Outcome Measures

Name	Time	Method
OR Time	At the time of surgery	minutes from procedure start to procedure end
Estimated Blood Loss	At the time of surgery	ml of blood loss based on surgeon estimate
Spillage of the morcellated tissue or fluids in the abdomen and pelvis	At the time of surgery	Following morcellation and removal of the bag, the abdomen and pelvis will be carefully examined for any signs of spillage of fluid, tissue or blue dye as well as the integrity of the containment system by the surgeon

Trial Locations

Locations (3)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Faulkner Hospital; 🇺🇸 Boston, Massachusetts, United States