| CTRI Number |
CTRI/2021/05/033777 [Registered on: 24/05/2021] Trial Registered Prospectively |
| Last Modified On: |
21/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive
Physiotherapy (Not Including YOGA)
Process of Care Changes
Behavioral
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Enhanced recovery after surgery protocol vs conventional care surgery in patients undergoing open Radical cystectomy with ileal conduit. |
|
Scientific Title of Study
|
Effect of enhanced recovery after surgery (ERAS)protocol in patients undergoing radical cystectomy and urinary diversion: A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anup Biswas |
| Designation |
SR |
| Affiliation |
PGIMER |
| Address |
Urology Office,Advance Urology Centre,Level 2,Nehru
Hospital,PGIMER Sector 12,PGIMER,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India
PGIMER, MDH,H111
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09681152697 |
| Fax |
|
| Email |
anup4cnmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF SK SINGH |
| Designation |
PROFESSOR AND H.O.D,UROLOGY DEPARTMENT, |
| Affiliation |
PGIMER |
| Address |
Urology Office,Advance Urology Centre,Level 2,Nehru
Hospital,PGIMER Sector 12,PGIMER,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009326 |
| Fax |
|
| Email |
shrawanksingh2002@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUDHEER K DEVANA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PGIMER |
| Address |
Urology Office,Advance Urology Centre,Level 2,Nehru
Hospital,PGIMER Sector 12,PGIMER,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008969 |
| Fax |
|
| Email |
drsudheer1983@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER,Sector 12,Chandigarh,160012-India |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
PGIMER Sector 12,PGIMER,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ANUP BISWAS |
PGIMER |
advance urology ward , level-2, 26 no ward , block B, PGIMER,Sector 12,PGIMER,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH |
9681152697
anup4cnmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional surgical care group |
Patients will be enrolled in the study with their complete knowledge, patient will be randomised into two groups , one group following ERAS protocol and other group following conventional surgical care, then two groups will be compared in terms of various post operative outcome.
Conventional Surgical Care Group will have thromboembolic prophylaxis by DVT stocking , removal of drain iF drain output LESS THAN 50 ML,with NASOGASTRIC TUBE till return of bowel sounds ,NO SHAM FEEDING, INITIATION OF ORAL LIQUIDS AND SOLID WHEN BOWEL SOUNDS RETURNS , compared to ERAS group. |
| Intervention |
ERAS Group |
1. Patients will be enrolled in the study with their complete knowledge, patient will be randomised into two groups , one group following ERAS protocol and other group following conventional surgical care, then two groups will be compared in terms of various post operative outcome. ERAS Group will undergo carbohydrate loading, pharmocological thromboembolic prophylaxis, early removal of drain irrespective of drain output after seeing drain fluid creatinine,without NASOGASTRIC TUBE ,SHAM FEEDING, EARLY INITIATION OF ORAL LIQUIDS AND SOLID as tolerated by the patient , compared to conventional surgical care group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ALL PATIENTS UNDERGOING OPEN RADICAL CYSTECTOMY WITH URINARY DIVERSION |
|
| ExclusionCriteria |
| Details |
1. Patients who will not give consent for inclusion in the study
2. History of prior radiotherapy
3. Patients planned for retentive diversions like ONB or CCD
4. Patient with other concomitant malignancy
5. patient with mental and cognitive disease
6. Patient with gastrointestinal disease affecting feeding
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of ERAS on length of hospital stay |
Primary outcome will be variable according to recovery of patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to appearance of bowel movement and passage of flatus
2. Time to drain removal
3. Peri-operative complications according to Clavien-Dindo classification
4. 30 day Readmission rate
|
30DAYS |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised ,parallel group trial , comparing effect of enhanced recovery after surgery (ERAS)protocol in patients undergoing radical cystectomy and urinary diversion in 54 patients for 14 months , will be conducted in P.G.I.M.E&R, CHANDIGARH,INDIA.The primary outcome measures effect of ERAS on length of hospital stay and secondary outcomes measures time to appearence of bowel movement and passage of flatus and stool, time to drain removal, perioperative complication according to clavien dindo classification , 30 days readmission rate . |