Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction

Hysterectomy Clinical Trial

Official title:

A Partners Prospective Study Assessing the Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496130
• Other study ID #: 2015P000230
• Status: Completed
• Start date: April 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Faulkner Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OR Time	minutes from procedure start to procedure end	At the time of surgery
Secondary	Estimated Blood Loss	ml of blood loss based on surgeon estimate	At the time of surgery
Secondary	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