| CTRI Number |
CTRI/2023/10/059101 [Registered on: 25/10/2023] Trial Registered Prospectively |
| Last Modified On: |
18/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
A study to know complications associated with esophagectomy |
|
Scientific Title of Study
|
Incidence of perioperative complications after transhiatal esophagectomy and transthoracic esophagectomy in a tertiary cancer centre:A retrospective study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonali Opneja |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Room No 1,
Operation theatre
Anesthesia cubicle
Department of Anaesthesia Malabar Cancer Centre
Thalassery
Kannur
KERALA
670103
India |
| Phone |
09765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Opneja |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Room No 1
Operation theatre
Anaesthesia cubicle
Department of Anaesthesia Malabar Cancer Centre
Thalassery
KERALA
670103
India |
| Phone |
09765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Opneja |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Room No 1
Operation theatre
Anaesthesia cubicle
Department of Anaesthesia Malabar Cancer Centre
Thalassery
KERALA
670103
India |
| Phone |
09765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malabar Cancer Centre
Kodiyeri
Thalassery
670103 |
|
|
Primary Sponsor
|
| Name |
Malabar cancer centre |
| Address |
Malabar Cancer Centre
Thalassery
Kodiyeri
670103 |
| Type of Sponsor |
Research institution |
|
|
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 Sonali Opneja |
Malabar cancer centre |
Room No 1
Operation theatre
Anaesthesia cubicle
Department of Anaesthesia
Thalassery
Kannur
KERALA |
09765635728
sopneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Committee,Instituitional Review Board,Malabar Cancer Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Those patients who have undergone esophagectomy from 1st January 2016 to 31st August 2023 |
|
| ExclusionCriteria |
| Details |
Patients with missing data |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of complications after transhiatal and transthoracic esophagectomy |
6 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| length of ICU stay, ventilation hours,lung complications/arrhythmias associated with esophagectomy |
6 years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/10/2023 |
| 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 Yet Recruiting |
| 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
|
This study is done to know the incidence of complications associated with esophagectomy done by two surgical techniques,transhiatal and transthoracic esophagectomy.It will also tell about the length of ICU stay,ventilation hours and lung complications/arrhythmias associated with esophagectomy. |