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

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

Study Overview

• Status: Completed
• Conditions: Hysterectomy

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
    • Boston, Massachusetts, United States, 02130
      • Faulkner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

70 adult women scheduled to undergo a laparoscopic hysterectomy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OR Time	minutes from procedure start to procedure end	At the time of surgery
Estimated Blood Loss	ml of blood loss based on surgeon estimate	At the time of surgery
Spillage of the morcellated tissue or fluids in the abdomen and pelvis	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	At the time of surgery

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Jon I Einarsson, MD, PhD, MPH, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: July 9, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: laparoscopy; minilaparotomy; morcellation
• Other Study ID Numbers: 2015P000230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO