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
|
|
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
|
|
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
|
|
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 |