跳至主要内容
临床试验/CTRI/2025/10/095877
CTRI/2025/10/095877尚未招募不适用

A prospective observational study to assess the compliance to enhanced recovery protocols and postoperative outcomes in patients undergoing retroperitoneal lymph node dissection surgeries for testicular germ cell tumor patients.

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年10月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
To assess the percentage compliance of the enhanced recovery pathway and it’s influence on the postoperative complications (defined by Clavien Dindo Classification) in patients undergoing RPLND surgery.

研究概览

简要总结

  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.

  1. 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.

  1. 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.

  1. 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.

  1. Ethical Consideration

This is an observational study, which does not alter the method of treatment or care offered to the patients by

any means.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Male

入选标准

  • All Adult Males more than 18 years of age undergoing RPLND Surgery.

排除标准

  • 1.Patients with severe comorbidities or contraindications that significantly impact surgical or postoperative management, such as advanced heart failure, severe chronic obstructive pulmonary disease, or end-stage renal disease 2.Patients in whom surgery was abandoned due to inoperability.

结局指标

主要结局

To assess the percentage compliance of the enhanced recovery pathway and it’s influence on the postoperative complications (defined by Clavien Dindo Classification) in patients undergoing RPLND surgery.

时间窗: 30 days post surgery

次要结局

  • 1.Postoperative length of hospital stay (LOS)(2.30-day readmission rate)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Anjana Wajekar

Tata Memorial Centre

研究点 (1)

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