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CTRI Number  CTRI/2017/09/009825 [Registered on: 18/09/2017] Trial Registered Prospectively
Last Modified On: 08/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   study of treatment given before, during and after female genital organ cancer operations 
Scientific Title of Study   Perioperative care pathway in Gynaecological Oncology:A Prospective Audit of current practice in a tertiary care hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijaya Patil  
Designation  Professor and Anaesthetist 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, E.Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA
same as address 1
Mumbai
MAHARASHTRA
400012
India 
Phone  9819883535  
Fax    
Email  vijayappatil@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijaya Patil  
Designation  Professor and Anaesthetist 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, E.Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA
same as address 1
Mumbai
MAHARASHTRA
400012
India 
Phone  9819883535  
Fax    
Email  vijayappatil@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Kiran S Pawar 
Designation  Junior Resident  
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, E.Borges Marg, Parel, Mumbai Mumbai MAHARASHTRA
same as address 1
Mumbai
MAHARASHTRA
400012
India 
Phone  9850826044  
Fax    
Email  kiran.r.pawar@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, E.Borges Marg, Parel,Mumbai 400012  
 
Primary Sponsor  
Name  not applicable 
Address  not applicable 
Type of Sponsor  Other [not applicable] 
 
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 Vijaya Patil  Tata Memorial Hospital, Parel, Mumbai  Room Number- MB 210, Department of Anaesthesia, Second Floor, Main Building
Mumbai
MAHARASHTRA 
9819883535

vijayappatil@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee I   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All non pregnant patients above 18 years of age undergoing elective surgery with a diagnosis of gynaecological malignancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  All patients aged 18 years and over undergoing elective surgery with a diagnosis of gynaecological malignancy 
 
ExclusionCriteria 
Details  Emergency gynaecological surgeries
Patients < 18 years
Pregnant women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
We aim to conduct a prospective audit of the current practices in the peri-operative care and postoperative morbidity in patients undergoing gynaec- oncology surgery and compare it with standard published ERAS guidelines and perform a gap analysis .  immediate perioperative period 
 
Secondary Outcome  
Outcome  TimePoints 
No Secondary Outcomes  No Secondary Outcomes 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
Final Enrollment numbers achieved (Total)= "609"
Final Enrollment numbers achieved (India)="609" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/09/2017 
Date of Study Completion (India) 31/08/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/08/2018 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Our study results showed that minimally invasive surgeries are associated with decreased length of the stay in the hospital after the surgery. Median day of discharge of day in open surgery was 5  and with the minimally invasive surgeries (MIS) was 4 And there was no difference in postop morbidity. We found statistically significant correlation between patients who underwent bowel preparation vs no bowel preaperation with decrease in Clavien Dindo grading in patients in whom bowel preparation was not done. Majority of patients in current audit had prolonged fasting (>6hours) In our study 46.5% patients received only single antiemetic agent. Our nurse patient ratio is quite poor in recovery room and surgeons are uncomfortable to send patients to recovery area without NGT but happy to remove it by 10-12 hours after surgery and thus almost 95.7 % patients had their NGT removed within 24 hours post-surgery. 5% patients who had NGT retained after 24 hours had significantly higher hospital length of stay (LOS) (median 5 days vs 7.5 days). Probably these patients had some problem like prolonged ileus or complicated bowel resections which increased hospital LOS rather than delayed removal of NGT. In our audit 29.6 % patients did not get drains and 8.9 % of patients drain was removed within 24 hours. Patients who had surgical drains for >24 hours had increased hospital LOS.  

32% of our patients had urinary catheter in place for more than 24 hours. And we found that early removal of urinary catheter had a statistically significant association with decreased post-operative morbidity outcomes as well as reduced readmissions and less hospital LOS. Our study showed that our surgeons were quite comfortable starting liquids orally within 24 hours but reluctant to give solids. We found that early oral fluid diet significantly decreased postoperative length of stay from 5 [2] to 3.5[1] and decreased the post-operative complications as per Clavien Dindo grading.Our study showed that our surgeons were quite comfortable starting liquids orally within 24 hours but reluctant to give solids. We found that early oral fluid diet significantly decreased postoperative length of stay from 5 [2] to 3.5[1] and decreased the post-operative complications as per Clavien Dindo grading.

What our study results show is our compliance to ERAS bundles is exteremely poor. Most of the elements where we found good compliance are part of standard practice for many years and not necessarily as part of ERAS bundles. Elements like preoperative antibiotic, avoidance of night sedation, multimodal analgesia are decided by anaesthetist and have excellent compliance. However other elements especially where surgeons are major decision makers, compliance rate is still very poor and probably reflect lack of awareness and unwillingness to adopt change. With proper education and institution of protocols, it is possible to improve compliance and postoperative outcomes

 
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