| CTRI Number |
CTRI/2024/05/067885 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study in patients undergoing gynaecological surgeries to estimate the duration of
perioperative fasting and its effect on the recovery profile. |
|
Scientific Title of Study
|
Prospective Observational study in patients undergoing gynaecological surgeries to estimate
the preoperative fasting and postoperative resumption of oral intake and its effect on the
immediate recovery profile
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SMITHA ELIZABETH GEORGE |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department Of Anaesthesia,
7th floor , Paul Brand Building,
CMCH, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282105 |
| Fax |
|
| Email |
smitha.lizgeorge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SMITHA ELIZABETH GEORGE |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department Of Anaesthesia,
7th floor , Paul Brand Building,
CMCH, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282105 |
| Fax |
|
| Email |
smitha.lizgeorge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SMITHA ELIZABETH GEORGE |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department Of Anaesthesia,
7th floor , Paul brand building,
CMCH, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282105 |
| Fax |
|
| Email |
smitha.lizgeorge@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid research grant, Christian Medical College, Vellore, India-632004 |
|
|
Primary Sponsor
|
| Name |
Other |
| Address |
Department of Anaesthesia
7th floor , Paul Brand building,
CMC hospital, Vellore. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 HANNAH AUGUSTINE |
Christian Medical College Hospital |
2nd floor, Operation Theatre room 3 and 4, 4th floor G4 West Inpatient Ward, Ida S Scudder Centenary Center Building.
Vellore
TAMIL NADU |
7208533857
hannah.augustine96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board and Ethics commitee of CMC Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, (2) ICD-10 Condition: N889||Noninflammatory disorder of cervixuteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing elective gynaecological and Gynaecologic oncology surgeries.
Age group 18 to 65
ASA 1 &2 |
|
| ExclusionCriteria |
| Details |
ASA 3 and 4 patients
emergency surgeries
Surgery needing massive blood transfusion
Surgeries with elective/unanticipated post op ventilation
Surgeries requiring post op ICU admission.
Age less than 18 years and more than 65 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of hours of preoperative and postoperative fasting |
postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the effect of hours of fasting and time for
resumption of fasting on recovery profile including postoperative nausea and
vomiting, ambulation, pain scores, number of days in hospital. To identify risk factors
for prolonged perioperative fasting in gynaecological surgeries. |
24hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
04/06/2024 |
| 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="3"
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 - NO
|
|
Brief Summary
|
One of the most commonly being practiced surgeries in India include Gynecology. A catabolic state is induced in the body because of the surgical stress that leads to tissue hypoxia, increased cardiac demand, increased insulin resistance, altered pulmonary and GI functions and abnormal coagulation profiles. The goal of maintaining normal physiology in the perioperative period, thus optimizing patient outcomes without increasing postoperative complications or readmissions, led to the development of ERAS. Implementation of ERAS protocol began in the early 90’s with the aim of improving post operative outcomes. ERAS stands for ENHANCED RECOVERY AFTER SURGERY. There is paucity of data on perioperative fasting and adherence to ERAS guidelines in gynaecologic practice in our country. Therefore we planned to do an observational study to estimate the duration of perioperative fasting, and assess how well ERAS guidelines with regard to perioperative fasting are implemented in the gynaecologic practice in our institution, and how it relates to the recovery of patients. The aim of this study will be to determine duration of perioperative fasting and its effect on the immediate recovery profile in patients undergoing gynaecologic and gynaecologic oncology surgeries. |