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CTRI Number  CTRI/2025/07/091096 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Probiotic
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to see how preparing patients before surgery through cardiorespiratory fitness, nutrition, and mental support — can help improve recovery and strength in people with colorectal cancer having planned surgery. 
Scientific Title of Study   Prehabilitation augmented Enhanced Recovery After Surgery in patients undergoing elective surgery for colorectal carcinoma: a randomized control trial 
Trial Acronym  PERAS(Prehabitation augmented Enhanced Recovery After Surgery) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Santhosh Kumar R 
Designation  Junior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research,Chandigarh 
Address  Room no 2,Office-Department of General Surgery,5th floor,B block,Nehru Hospital,PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  8610134655  
Fax    
Email  santhoshkumarravi21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Satish S N 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research,Chandigarh 
Address  Office-Department of General Surgery,5th floor,B block,Nehru Hospital,PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9790674694  
Fax    
Email  drsnsatish06@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Satish S N 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research,Chandigarh 
Address  Office-Department of General Surgery,5th floor,B block,Nehru Hospital,PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9790674694  
Fax    
Email  drsnsatish06@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research,Chandigarh 160012 
 
Primary Sponsor  
Name  Dr.Santhosh Kumar R 
Address  Room no 2,Office-Department of General Surgery,5th floor,B block,Nehru Hospital,PGIMER,Sector 12,Chandigarh-160012 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santhosh Kumar R  Postgraduate Institute of Medical Education and Research,Chandigarh  Room no 2-Office-Dept of General Surgery,B block,5th floor,Nehru hospital,PGIMER
Chandigarh
CHANDIGARH 		 8610134655

santhoshkumarravi21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER,Chandigarh-Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High protein diet,Cardiorespiratory exercises,Psychological betterment,CAP.PREPROKEN,L-GLUTAMINE SACHET,SYP CAXFILA OS.  High protein diet acc to ideal body weight,Incentive spirometry,Brisk walking min 30 mins daily,Resistance training,Stress management techniques,cognitive behavioural therapy and counselling,PRE AND PROBIOTICS 1capBD,IMMUNONUTRITION 15gBD,APPETITE STIMULANT 4mlBD. 
Comparator Agent  NIL  NIL. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Adults aged 18-90 years
2.Both gender
3.Biopsy proven colorectal carcinoma requiring surgical resection
4.Able to provide informed consent
5.ASA 1 or 2 patients 
 
ExclusionCriteria 
Details  1.Age less than 18yrs or more than 90yrs
2.Inability to comprehend or follow PERAS protocol
3.Patients not providing valid informed consent
4.Pregnant patients
5.Patients with psychiatric disorders
6.Patients presenting to emergency with obstruction or perforation in colorectal carcinomas 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)To compare the length of hospital stay, postoperative complications, and readmission
rates between patients managed with Prehabilitation augumented ERAS and those receiving
traditional ERAS care.
2)To assess patient-reported outcomes, such as pain scores, bowel function recovery,
quality of life and emotional well being in the two groups.
3)To evaluate the cost-effectiveness of the Prehabilitation augumented ERAS protocol in
comparison to traditional ERAS pathways 		 Primary outcomes pertaining to this study specifically includes those which are used to determine the effects of intervention i,e, prehabilitation.Measures including borg scale,6MWT,hand grip test,improvement in pulmonary function test,duke activity index,change in BMI,PHQ9,GAD7 score etc will be assessed,
1.)At baseline,
2.)At 4 weeks,
3.)At 8 weeks, from the point of diagnosis/start of prehabilitative intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
1)To assess readmission rates within 30 days post surgery
2)To assess response to adjuvant chemotherapy & related complications 		 Within 30 days of post operative period. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Phase 2 
Date of First Enrollment (India)   30/07/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [santhoshkumarravi21@gmail.com].

  6. For how long will this data be available start date provided 28-06-2026 and end date provided 28-06-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Background & Purpose of the Trial:

Patients undergoing surgery for colorectal cancer often face physical weakness, poor nutrition, and emotional stress, which can delay recovery. While Enhanced Recovery After Surgery (ERAS) protocols help improve outcomes after surgery, recent research suggests that helping patients get stronger before surgery—through exercise, better nutrition, and psychological support—may further improve results.

This study aims to find out whether adding a structured prehabilitation program before surgery leads to better fitness, mental health, and faster recovery in patients with colorectal cancer undergoing planned surgery.

 
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