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Completed

NCT Number: NCT02496130

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Brigham & Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Return to daily activities

    Time frame: 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 outcomes

  1. OR Time

    Time frame: At the time of surgery

    minutes from procedure start to procedure end

  2. Estimated Blood Loss

    Time frame: At the time of surgery

    ml of blood loss based on surgeon estimate

  3. Spillage of the morcellated tissue or fluids in the abdomen and pelvis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2015
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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