Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction

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

Detailed Description
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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.

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

Conditions
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Hysterectomy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| minilaparotomy<br>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<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minilaparotomy, morcellation, laparoscopy