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CTRI Number  CTRI/2024/09/073665 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 02/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Decrease in mental function in patients undergoing elective laparotomy for cancer surgeries 
Scientific Title of Study   Postoperative cognitive decline in patients undergoing elective laparotomy for cancer surgeries in a tertiary care centre: A prospective cohort study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonali Turki 
Designation  Senior Resident (Acad) 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Office of Department of Onco-Anaesthesia and Palliative Medicine 1st Floor, Dr BRA IRCH AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  6005373424  
Fax    
Email  sonaliturki@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rakesh Garg 
Designation  PROFESSOR 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Dr Rakesh Garg Faculty Offices 1st Floor Dr BRA IRCH AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9810394950  
Fax    
Email  drrgarg@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Rakesh Garg 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Dr Rakesh Garg Faculty Offices 1st Floor Dr BRA IRCH AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9810394950  
Fax    
Email  drrgarg@hotmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences New Delhi India - 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  All India Institute Of Medical Sciences (AIIMS) , Ansari Nagar , New Delhi - 110029 (India) 
Type of Sponsor  Government medical college 
 
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 Rakesh Garg  All India Institute of Medical Sciences, New Delhi  Dr Rakesh Garg Faculty Offices 1st Floor Dr BRA IRCH AIIMS, New Delhi
New Delhi
DELHI 		 9810394950

drrgarg@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R418||Other symptoms and signs involvingcognitive functions and awareness,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  N/A 
Comparator Agent  NIL  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
Adult patients (≥18 years of age).
Undergoing elective laparotomy for cancer under general anaesthesia.
 
 
ExclusionCriteria 
Details  Exclusion criteria:
Patients who cannot read or write.
Patients who cannot understand either English or Hindi.
Patients with known neuropsychiatric disorders.
Patients with a history of central nervous system disease or cerebrovascular disease with sequelae.
Patients with a history of developmental or mental intellectual disability and cognitive impairment.
Patients with known brain metastasis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of postoperative cognitive decline in patients undergoing elective laparotomy for cancer surgeries under general anaesthesia at one week post-surgery.  1 week post-surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of postoperative cognitive decline in patients undergoing elective laparotomy for cancer surgeries under general anaesthesia at three months post-surgery.
2. Predictors of postoperative cognitive decline in patients undergoing elective laparotomy for cancer surgeries under general anaesthesia. 		 At 3 months post surgery 
 
Target Sample Size   Total Sample Size="288"
Sample Size from India="288" 
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)   17/09/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Aim: To study postoperative cognitive decline among cancer patients undergoing elective laparotomy surgeries under general anaesthesia in a tertiary care centre
Study Design: A single-centred, prospective cohort study.
Study Site: Department of Onco-Anaesthesia and Palliative Medicine, BRAIRCH, AIIMS, New Delhi and NCI AIIMS Jhajjar.
Study Duration: Prospective analysis of case-specific data on patients undergoing elective laparotomy for cancer from 1st July 2024 to 31st December 2025.
Inclusion criteria:
Adult patients (≥18 years of age).
Undergoing elective laparotomy for cancer under general anaesthesia.
Exclusion criteria:
Patients who cannot read or write.
Patients who cannot understand either English or Hindi.
Patients with known neuropsychiatric disorders.
Patients with a history of central nervous system disease or cerebrovascular disease with sequelae.
Patients with a history of developmental or mental intellectual disability and cognitive impairment.
Patients with CNS metastasis.
Preoperative Visit
Patients matching the inclusion criteria will be recruited.
Written and informed consent will be obtained from the patients after explaining the study protocol and answering any queries.
Baseline assessment of neurocognitive status will be done by a battery of tests, including Hindi Mental State Examination (HMSE), Addenbrooke’s Cognitive Examination–III (ACE–III), Trail Making Test–A (TMT–A), Trail Making Test–B (TMT–B), one day before surgery.
The demographic profile, comorbidities, medication history, administration of neoadjuvant chemotherapy (NACT), neoadjuvant radiotherapy (NART).
Patient’s comorbidity status will be evaluated by Charlson Comorbidity Index (CCI).
Clinical Frailty Scale (CFS) will be used to assess frailty of the patient.
Anaesthesia Technique
All laparotomy cases are usually done under general anaesthesia with or without regional anaesthesia.
ASA Standard-II monitoring is done for all patients with advanced cardiac output monitoring done for high-risk surgeries.
Postoperative analgesia is usually based on anaesthesiologists’ discretion, and various options include local anaesthetic infusions in epidural, Epidural morphine or interfacial truncal plane blocks or intravenous morphine/fentanyl by patient-controlled analgesia pumps when regional anaesthesia cannot be administered.
Standard hospital procedures and protocols for anaesthesia, surgery and perioperative care will be followed.
Decisions about the exact anaesthetic techniques will be at the discretion of the concerned anaesthesia team independent of the investigator and will be recorded. The type of surgery, surgical duration, and blood loss shall be recorded.
Observation (1 week)
Patients will be followed one week after the surgery, and details related to postoperative analgesia and any complications, including blood transfusion, shall be recorded.
Assessment of neurocognitive status will be repeated using a battery of tests, including HMSE, ACE–III, TMT–A, and TMT–B.
Postoperative complications will be evaluated by Clavien Dindo Complication Classification (CDCC) at 1 week.
Observation (3 months)
Patients will be followed three months after the surgery.
Assessment of neurocognitive status will be done using a battery of tests, including HMSE, ACE–III, TMT–A, and TMT–B.
The treatment administered to the patient during this period will be noted, including chemotherapy, radiotherapy, and combination therapy.
Primary Outcome:
Incidence of postoperative cognitive decline in patients undergoing elective laparotomy for cancer surgeries under general anaesthesia at one week post-surgery.
Secondary Outcomes:
Incidence of postoperative cognitive decline in patients undergoing elective laparotomy for cancer surgeries under general anaesthesia at three months post-surgery.
Predictors of postoperative cognitive decline in patients undergoing elective laparotomy for cancer surgeries under general anaesthesia.
Tools
1.Hindi Mental State Examination (HMSE)
2. Addenbrooke’s Cognitive Examination–III (ACE–III)
3. Trail Making Test–A (TMT–A)
4. Trail Making Test–B (TMT–B)

The tool for assessing comorbidities: Charlson Comorbidity Index (CCI)

The tool for assessing frailty: Clinical Frailty Scale (CFS)

The tool for assessing postoperative complications: Clavien Dindo Complication Classification (CDCC)

Sample Size
Incidence of POCD in cancer surgeries at one week is 19 – 33%. Assuming 25% incidence in present study with 5% absolute margin of error either the side with 95% confidence level, a sample of 288 patients will be needed.

Data Interpretation
The data will be recorded in MS Excel spreadsheet program.
After the study, data analysis will be done, and the incidence with a 95% confidence interval shall be reported.
Chi-square and paired t-tests shall be used for the analysis of various baseline parameters for 7 days and 3 months.
Univariable and multivariable regression analysis will be performed to find the predictors of POCD. For secondary data analysis, we will use multiple logistic regression to investigate associations between risk factors on the neurocognitive tests 1 week and 3 months after the surgery.
 
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