Whipple Warriors Survey

* 1. Division of Surgical Oncology at the Department of Surgery
Sylvester Comprehensive Cancer Center
University of Miami-Miller School of Medicine

Dear Whipple Warrior,

We are asking you to take part in a research study because we are trying to learn more about the long term effect of Whipple procedure on quality of life and gastrointestinal function in patients who had the procedure. You will be asked to answer two survey questionnaires: one on general quality of life and the other on specific gastrointestinal symptoms and signs you may have encountered since your Whipple surgery. It will take you about 5-10 minutes to complete the survey, which does not include any personal identifiers, names or personal information.

There should be no foreseeable risk to you from answering these questions. You will not benefit directly from participating in this research study, the results of this study will have the benefit of informing the medical community of the most common signs and symptoms that you the patient may have experienced after your Whipple surgery and how these symptoms have been managed to educate all the physicians treating you and other Whipple patients on how to handle these symptoms and signs the best way.

You will not be paid for participating in this research study. Information supplied in this study will be anonymously handled, compiled and data analyzed by the research team at the Division of Surgical Oncology, University of Miami, Florida, USA. Results will be disseminated via publication in medical journals and may be presented in scientific meetings. The research team will not have access to your information or contacts, you will not be contacted with any of the results of the analysis of these data.

All of your answers will be coded by a special identifying number rather than your name. All of the papers pertaining to the study will be kept in a locked file cabinet, and all electronic data will be stored in computer files. Only people who are directly involved with the project will have access to those records. When the project is finished and results are reported, no individual will be identified in any way.

Your participation is voluntary. You can decline to participate, and you can stop your participation at any time, if you wish to do so, without any negative consequences to you. By you answering the survey/interview questions that I will ask, this means you consent to participate in this research project.

If you have any questions or concerns about the research, please feel free to contact:

Principal Investigator: Dr Danny Yakoub MD PhD FACS. +1-305-243-4902
Co-Investigator: Dr Nipun Merchant MD FACS. +1-305-243-4902
Co-Investigator: Dr Vikas Dudeja MD. +1-305-243-4902

Division of Surgical Oncology at the Department of Surgery,
University of Miami-Miller School of Medicine
Clinical Research Building, 4th Floor,
1120 NW 14th Street
Miami, FL 33136
USA

If you have questions regarding your rights as a research participant, contact the University of Miami, Human Subject Research Office at (305)243-3195.