Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction

Mass General Brigham

Status: Completed

Conditions: Hysterectomy

Study type: Observational

Funder types: Other

Identifiers

NCT02496130

2015P000230

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

minilaparotomy

Description:

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

Description:

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.