| CTRI Number |
CTRI/2019/02/017573 [Registered on: 11/02/2019] Trial Registered Prospectively |
| Last Modified On: |
09/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Nested case control |
| Study Design |
Other |
|
Public Title of Study
|
Does robot cancer surgeries change the decision to remove airway tube early. |
|
Scientific Title of Study
|
Does robotic assisted lower abdominal oncological surgeries change the determinants of immediate extubation in the operating room: Our early experience. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavitha Lakshman |
| Designation |
Assistant Professor |
| Affiliation |
Kidwai Cancer Institute |
| Address |
Department of Anesthesiology
Kidwai Cancer Institute
Dr M H Marigowda road
Bangalore 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9480333357 |
| Fax |
|
| Email |
drkavithalakshman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavitha Lakshman |
| Designation |
Assistant Professor |
| Affiliation |
Kidwai Cancer Institute |
| Address |
Department of Anesthesiology
Kidwai Cancer Institute
Dr M H Marigowda road
Bangalore 560029
KARNATAKA
560029
India |
| Phone |
9480333357 |
| Fax |
|
| Email |
drkavithalakshman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha Lakshman |
| Designation |
Assistant Professor |
| Affiliation |
Kidwai Cancer Institute |
| Address |
Department of Anesthesiology
Kidwai Cancer Institute
Dr M H Marigowda road
Bangalore 560029
KARNATAKA
560029
India |
| Phone |
9480333357 |
| Fax |
|
| Email |
drkavithalakshman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kidwai Cancer Institute
Department of Anesthesiology
Dr. M H Marigowda road
Bangalore 560029 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of Anesthesiology
Kidwai Cancer Institute
Dr M H Marigowda road
Bangalore 560029 |
| 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 |
| Kavitha Lakshman |
Kidwai Cancer Institute |
Department of Anesthesiology
Kidwai Cancer Institute
Dr M H Marigowda road
Bangalore 560029
Bangalore
KARNATAKA |
9480333357
drkavithalakshman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C20||Malignant neoplasm of rectum, (2) ICD-10 Condition: C21||Malignant neoplasm of anus and anal canal, (3) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (4) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (5) ICD-10 Condition: C53||Malignant neoplasm of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patient extubated after 30min |
Factors contributing to delayed extubation |
| Comparator Agent |
Patient who are extubated within 30min |
Factors contributing to early extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing robot assisted lower abdominal oncological surgery |
|
| ExclusionCriteria |
| Details |
Robotic surgery converted to open procedure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extubation |
At 30min post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of elective ventilation |
Within 24hours of surgery |
|
|
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)
|
11/02/2019 |
| 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
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Generally robotic surgeries are prolonged , associated with delayed extubation. Patient undergoing robot assisted lower abdominal surgeries will be assessed for determinants of early extubation. Factors contributing to delayed extubation present in patient who are extubated after 30minites will be assessed. This study will identifying the factors which are going to delay extubation. |