| CTRI Number |
CTRI/2009/091/000071 [Registered on: 02/04/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the effects of two forms of reconstruction, uncut roux-en-y gastrojejunostomy and standard roux-en-y gastrojejunostomy following partial gastrectomy or palliative bypass in patients with cancer of stomach |
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Scientific Title of Study
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A randomised trial comparing short-term outcomes of "Uncut" Roux-en-Y gastrojejunostomy and standard Roux-en-Y gastrojejunostomy following partial gastrectomy/palliative bypass for gastric adenocarcinoma |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
NAGARAJ PALANKAR |
| Designation |
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| Affiliation |
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| Address |
Surgery Unit III, Christian Medical College Hospital
218, Hospital Annexe, CMC Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
09994882487 |
| Fax |
04162232035 |
| Email |
nagarajpalankar@gmail.com |
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Details of Contact Person
Scientific Query
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| Name |
DR.GEORGE MATHEW |
| Designation |
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| Affiliation |
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| Address |
Surgery Unit III, Christian Medical College Hospital
Principal's Office, Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282079 |
| Fax |
04162232035 |
| Email |
gmathewcmc@yahoo.com |
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Details of Contact Person
Public Query
|
| Name |
DR.GEORGE MATHEW |
| Designation |
|
| Affiliation |
|
| Address |
Surgery Unit III, Christian Medical College Hospital
Principal's Office, Christian Medical College
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282079 |
| Fax |
04162232035 |
| Email |
gmathewcmc@yahoo.com |
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Source of Monetary or Material Support
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| Fluid Research Grant from Christian Medical College, Vellore, India. |
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Primary Sponsor
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| Name |
Christian Medical College, Vellore, India. |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.George Mathew |
Christian Medical College |
Surgery Unit III, Christian Medical College Hospital,Principal's Office, Christian Medical College-632004
Vellore
TAMIL NADU |
04162282079
04162232035
gmathewcmc@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College, Vellore, India |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Gastric Cancer, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Standard Roux-en-Y gastrojejunostomy |
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| Intervention |
Uncut Roux-en-Y gastrojejunostomy |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Patients undergoing partial gastrectomy for gastric adenocarcinoma.
2. Age of the patient: 18 years and above.
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| ExclusionCriteria |
| Details |
Patients who have undergone prior gastric operations or vagotomy |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| 1. Gastric emptying time by nuclear gastric emptying scan.
2. Time taken to institute solid diet |
Gastric emptying time on the 15th postoperative day |
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Secondary Outcome
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| Outcome |
TimePoints |
| 1. Mortality rate.
2. Overall morbidity rate.
3. Time taken to discontinue nasogastric intubation.
4. Viscik grading pre- and post-operatively.
5. Post-operative hospital stay.
6. Any reoperation.
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Immediate postoperative period during the hospital stay |
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Target Sample Size
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Total Sample Size="68"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/05/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a randomised control trail comparing the effects of 2 forms of reconstruction after partial gastrectomy for gastric cancer viz, uncut Roux-en-Y gastrojejunostomy and standard Roux-en-Y gastrojejunostomy. The study will be conducted at Christian Medical College, Vellore. Sixty-eight patients who fulfill the inclusion and exclusion criteria will be enrolled for the study. The primary outcome measures will be gastric emptying time on 15th postoperative day by nuclear scan and time taken to institute solid diet postoperatively. The secondary outcome measures will be overall mortality rate,
overall morbidity rate, time taken to discontinue nasogastric intubation, pre- and post-operative Viscik grading, duration of post-operative hospital stay and need for reoperation.
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