A Pilot Observational Study on activity levels after hysterectomy

Study ID
STU 052016-062

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Farzin Ahmed
817/734-3956
Farzin.Ahmed@UTSouthwestern.edu

Principal Investigator
Jerry Green, D.O.

Summary

3. Concise Summary of Project:
This pilot study is observational in nature. only data will be collected, with no change in current clinical care. Patients undergoing hysterectomy by various approaches (open, laparoscopic, vaginal) will be consented to join the study during their preoperative anesthesia visit approximately one week prior to surgery. Patients will be identified during their surgery surgical preoperative clinic visit or anesthesia visit (Parkland Hospital) for the eligibility. Data base (ePiC) will also be used for prescreening of potential subject by reviewing surgery, anesthesia, and clinic schedules.

eligible subject will be approached by the study Pi, investigators, or research coordinator. if patient is interested, consent will be obtained during a face to face meeting in a private room.

Ten patients who give consent will have wrist based activity monitors (Garmin Vivofit 2) attached at their preoperative visit approximately one week prior to surgery and are worn 24/7. These will be worn and data collected upon admission for surgery, at discharge, and at a postoperative visit, typically 3-4 weeks later.

Garmin Vivofit 2 will be used. The device is a wrist worn, water resistant activity monitor with 1 year of battery life. There is no limitation on activities of daily life such as hand washing, shower or any other activity. The wearer gets feedback on daily activity level visually and configurable to audio. inactivity cues are available in 15 min intervals.

The parameters recorded in the activity tracker over time are:
* Steps
* Distance
* Calories
* Sleep

The information recorded by activity tracker will be downloaded during hospital stay or during regular office visit. The information will be downloaded to a tablet, smartphone or laptop. The investigator and study personnel will have sole access to downloaded activity level data recorded during the study. as each participant completes his portion of the study, the device will be turned over to the study participant. The study participant will have continuous access to real time activity level while participating in the study.

Pain will be evaluated at postoperative Day (PoD) 1, PoD2, and at postoperative follow-up by using a pain scale such as Defense and Veterans Pain rating Scale (0[?] no pain and 10[?] as bad as it could be). a supplemental quality of life questionnaire (such as DoD/Va Pain Supplemental Questions) will be also be used PoD1, PoD2, at follow-up visit. Postoperative pain scores during hospital stay will also be collected from ePiC/eMR.

Total narcotic use, antiemetic use, nausea and vomiting, length of hospital stay, itching, urinary retention, and functional recovery or quality of life indices will be collected. Data on these secondary endpoints will be collected from ePiC/eMR and directly during patient visits.

Patients will receive a standard general anesthetic for their surgery and postoperative standard of care pain treatment similar to all patients. Study does not limit standard post-operative pain medication.

Primary outcome measures: activity level preoperatively and extent and time course of return to baseline activity throughout the postoperative period through the first postoperative clinic visit.

Secondary outcome measures: Pain scores, antiemetic use, narcotic use, and quality of life scores.


Participant Eligibility


* Age between 18-65

* Undergoing hysterectomy by various approaches (open, laparoscopic, vaginal)

* Willing to use wrist based activity monitors

* Able to understand how to use wrist activity monitor