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1. What the study is about?
This is an observational study looking at how patients recover after a major operation called Retroperitoneal
Lymph Node Dissection (RPLND). This surgery is often needed for testicular cancer. We will see how well
special care plans, known as "enhanced recovery protocols," are being used and how they affect patients’
recovery. These special plans include things done before, during, and after surgery to help patients get better
faster and with fewer problems.
2. Who will be included in this study?
Adult patients (18 years or older) who are scheduled to have this specific RPLND surgery for testicular
cancer may be part of this study.
Patients who have very serious other health problems that could greatly affect their surgery or recovery, or if
their planned surgery cannot be completed, would not be included.
The study will begin after the Institutional ethics committee (IEC) approval and Clinical Trials Registry of
India registration. The study will be conducted at both ACTREC, Tata Memorial Centre, Navi Mumbai and
TMH, Tata Memorial Centre, Parel.
3. What information is collected and how patients are monitored?
There are certain "enhanced recovery" steps which are proven to benefit patients undergoing major
surgeries. Education regarding these steps will be provided to all anaesthesia and surgical trainees, nurses,
nutritionists and physiotherapists as part of a multidisciplinary team. The study will collect information
about how closely the "enhanced recovery" steps are followed for each patient. This includes things like:
Before surgery: Advice given, efforts to stop smoking/alcohol, nutrition checks, and exercises.
During surgery: Type of anaesthesia, fluids given, how body temperature was kept normal, etc.
After surgery: Pain relief, how quickly patients get moving and eating, and when tubes are removed.
We will also gather general information like age, overall health, details about the surgery (like how long it
took), any postoperative complications, how long patients stay in the hospital, and if they need to be
readmitted to the hospital within 30 days. This information will be collected by a research nurse from the
patients’ medical records/ anesthesia notes/ surgery notes. There will be no direct contact with the patients.
4. Data safety and confidentiality
Case record forms (physical copies) will be stored in the office of the principal investigator, which will be
accessible only to the principal and co-investigators. Each study participant will be assigned an ID code.
Patient confidentiality will be maintained during data analysis.
5. Ethical Consideration
This is an observational study, which does not alter the method of treatment or care offered to the patients by
any means.
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