Forward in time study, to determine the association of pre-operative nutritional status with the 90 days post-operative complications among patients undergoing urinary bladder removal surgery

Not yet recruiting

• Conditions: Malignant neoplasm of bladder, unspecified,

• Registration Number: CTRI/2019/11/022010
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Bladder cancer is among the top ten cancers in the world. Muscle invasive bladder cancer constitutes of approximately one-fourth of the total bladder cancers. Radical cystectomy which is the gold standard treatment for bladder cancer is associated with higher morbidity and mortality. Also nutritional status of patients is associated with post surgical recovery of patients. Most of the literature on association of pre-operative malnutrition and post radical cystectomy complications comes from retrospective studies. Therefore we intend to perform a prospective cohort study to assess the association of pre-operative nutritional status and 90 days morbidity in patients undergoing radical cystectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-14
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Adult patients [age ≥ 18 years].
• 2.Planned for Radical cystectomy.
• 3.Patients who can read,write and understand English language.
• 4.Who give written informed consent.

Exclusion Criteria

Patients unfit/unwilling for surgery.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To correlate the preoperative nutritional status with the 90 days morbidity in patients undergoing radical cystectomy for muscle invasive bladder cancer.	pre-operative nutritional status recorded upto within one week prior to surgery and morbidity upto 90 days post surgery

Secondary Outcome Measures

Name	Time	Method
1.To assess the effect of the preoperative nutritional status on the peri-operative parameters - duration of surgery, estimated blood loss, amount of blood transfused.	During radical cystectomy.
2.To assess the effect of the pre-operative nutritional status on the length of hospital stay, readmission rates and the day of ureteric stent removal.	From day of surgery upto 90 days post-operatively
3.To determine the prevalence of pre-operative poor nutritional status among the patients undergoing radical cystectomy.	Once within one week prior to surgery

Trial Locations

Locations (1)

Tata Memorial Centre; 🇮🇳 (Suburban), MAHARASHTRA, India

Tata Memorial Centre

🇮🇳(Suburban), MAHARASHTRA, India

Dr Ganesh Bakshi

Principal investigator

9869331584

bakshigk@tmc.gov.in