Hysterectomy
Conditions
Keywords
minilaparotomy, morcellation, laparoscopy
Brief summary
The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery.
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.
Interventions
None listed
Sponsors
Massachusetts General Hospital
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return to daily activities | 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
| Measure | Time frame | Description |
|---|---|---|
| OR Time | At the time of surgery | minutes from procedure start to procedure end |
| Estimated Blood Loss | At the time of surgery | ml of blood loss based on surgeon estimate |
| Spillage of the morcellated tissue or fluids in the abdomen and pelvis | 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 |
Countries
United States
Outcome results
None listed