| CTRI Number |
CTRI/2021/12/038675 [Registered on: 16/12/2021] Trial Registered Prospectively |
| Last Modified On: |
15/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to find out how often is a low body temperature seen during planned (not emergency) oesophagectomy (removal of part or whole of oesophagus) surgery with possible causes and effects leading to the same in a tertiary care (speciality)hospital |
|
Scientific Title of Study
|
An observational study to find out the incidence, causes and effects of intra-operative
hypothermia during elective esophagectomy at a tertiary care centre. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRSWAPNIL PARAB |
| Designation |
PROFESSOR |
| Affiliation |
Tata Menorial Centre, Parel, Mumbai |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, CRITICAL CARE AND PAIN,
TATA MEMORIAL HOSPITAL, DR.ERNEST BORGES ROAD,
PAREL, MUMBAI-12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9819319866 |
| Fax |
|
| Email |
swapnil.parab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSWAPNIL PARAB |
| Designation |
PROFESSOR |
| Affiliation |
Tata Menorial Centre, Parel, Mumbai |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, CRITICAL CARE AND PAIN,
TATA MEMORIAL HOSPITAL, DR.ERNEST BORGES ROAD,
PAREL, MUMBAI-12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9819319866 |
| Fax |
|
| Email |
swapnil.parab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SARGAM KANT |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Tata Memorial Centre, Parel, Mumbai |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, CRITICAL CARE AND PAIN,
TATA MEMORIAL HOSPITAL, DR.ERNEST BORGES ROAD,
PAREL, MUMBAI-12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167628811 |
| Fax |
|
| Email |
sargam.kant@gmail.com |
|
|
Source of Monetary or Material Support
|
| AS IT IS AN OBSERVATIONAL STUDY, NO MONETARY SOURCE IS REQUIRED |
|
|
Primary Sponsor
|
| Name |
TAAT MEMORIAL CENTRE |
| Address |
DR ERNEST BORGES ROAD
PAREL
MUMBAI-12 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SWAPNIL PARAB |
TATA MEMORIAL HOSPITAL |
Room No 210,Main OT Complex, 2nd Floor, Main Building, Tata Memorial Hospital,Parel
Mumbai
MAHARASHTRA |
9819319866
02224146937
swapnil.parab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, TATA MEMORIAL CENTRE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients undergoing elective esophagectomy surgery at TMH. |
|
| ExclusionCriteria |
| Details |
refusal of consent, emergency surgeries, inoperability after exploration,
and performing any other procedure in addition to esophagectomy. Those patients with the
missing data will not be considered for analysis. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To find out the incidence of hypothermia during elective esophagectomy surgeries. |
5 YEARS (4 YEARS RETROSPECTIVE AND 1 YEAR PROSPECTIVE) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the association between various pre-operative and intra-operative factors and
the incidence of hypothermia during esophageal surgeries.
ï‚· To find out the association between hypothermia and the incidence of post-operative
complications within 7 days of surgery. |
5 years (4 years retrospective and 1 year prospective) |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
27/12/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Meta-analyses and randomized controlled trials have shown that intraoperative hypothermia is correlated with occurrence of wound infection, cardiac morbidities, bleeding and transfusion requirement, shivering and increased post-operative discomfort, negative catabolism and nitrogen balance, and an overall higher mortality. Consequently, perioperative temperature monitoring and avoidance of intraoperative hypothermia are recognized as worthy quality improvement measures aimed at optimizing surgical care. Many perioperative factors make the patient prone for intraoperative hypothermia during esophagectomy surgeries. These include- preoperative weight loss, alopecia due to neo-adjuvant chemotherapy, long duration of surgery, opening of two body cavities (thorax and abdomen) use of capnothorax and/or pneumo- peritoneum, and blood loss during the surgeries. Mild hypothermia (core temperature between 34-36 degrees Celsius) is noted in 20-50% of patients undergoing esophageal surgeries. [4] Measures to avoid hypothermia include pre-emptive skin warming, maintenance of operating room temperature at 21 °C or 69.8 °F, humidification of airway, intravenous fluid warming, applying blanket for skin coverage, forced-air convective warming system, circulating water mattresses, circulating water garments, or combinations of methods [5] In this context, we would conduct a amphi-directional (4 years retrospective and one year prospective) observational study to find the incidence of hypothermia, the causes for the hypothermia and its effect on the early post-operative complications in adult patients undergoing esophagostomies at tertiary care cancer centre
Following data will be collected: a. Demographic data (age, sex, weight, height, BMI) b. Pre-operative data: like pre-operative weight loss,preoperative co-morbidities, details of neo-adjuvant treatment c. Intra-operative data temperature recording and temperature maintaining devices d. Details of core body temperature record every one hour during the duration of surgery e. Details of any intra-operative complication (need for vasopressors, arrhythmia, desaturation etc.) f. Post-operative details: like shivering, respiratory and cardiac complications, surgical site infections Demographic data will be analyzed using frequencies, and the averages with measurements of dispersion of data. Descriptive data will be analyzed using frequencies, means, standard deviations and ranges. Association between various factors and the hypothermia will be tested by multivariate analysis to find out independently associated factors. |