| CTRI Number |
CTRI/2010/091/003023 [Registered on: 17/01/2011] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study whether prolonged nasogastric drainage is essential following esophagectomy. |
|
Scientific Title of Study
|
Is prolonged nasogastric decompression following esophagectomy necessary? A prospective randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 213 |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R C Mistry |
| Designation |
|
| Affiliation |
|
| Address |
Tata Memorial Hospital
Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177000 |
| Fax |
022-24168604 |
| Email |
mistryrc@tmcmail.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C S Pramesh |
| Designation |
|
| Affiliation |
NIL |
| Address |
Tata Memorial Hospital
Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177070 |
| Fax |
022-24168604 |
| Email |
cspramesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C S Pramesh |
| Designation |
|
| Affiliation |
|
| Address |
Tata Memorial Hospital
Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177070 |
| Fax |
022-24168604 |
| Email |
cspramesh@gmail.com |
|
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Source of Monetary or Material Support
|
| Tata Memorial Hospital, Mumbai |
|
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Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
|
| Type of Sponsor |
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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 C S Pramesh |
Tata Memorial Hospital |
Dr E. Borges Road,Parel-400012
Mumbai
MAHARASHTRA |
022-24177070
022-24168604
cspramesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hospital ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Prolonged nasogastric decompression; Esophagectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Nasogastric decompression for 48 hours |
Not applicable |
| Intervention |
1. Nasogastric decompression for 48 hours |
Not applicable |
| Comparator Agent |
2. Nasogastric decompression till contrast esophagogram (6-10 days) |
Not applicable |
| Comparator Agent |
2. Nasogastric decompression till contrast esophagogram (6-10 days) |
Not applicable |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Patients who undergo transthoracic or transhiatal esophagectomy for biopsy proven esophageal cancer.
2. Patients with gastric tube reconstruction and esophago-gastric anastomosis.
|
|
| ExclusionCriteria |
| Details |
1.Patients who undergo thoracoabdominal esophagogastrectomy.
2.Patients who undergo colonic transposition.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| 1. Pulmonary Complications
2. Anastomotic leak |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1. RT reinsertion rate.
2. Patient discomfort.
3. Peri-operative Mortality. |
|
| 1. RT reinsertion rate.
2. Patient discomfort.
3. Peri-operative Mortality. |
|
|
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Target Sample Size
|
Total Sample Size="150"
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" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/10/2006 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This study is a prospective randomized controlled trial to assess if prolonged nasogastric decompression is necessary after esophagectomy. The study was planned for 150 patients. The primary outcome measures were assessing pulmonary complications and anastomotic leaks. The secondary outcome measures were Ryle's tube re-insetion rate, patient discomfort and peri-operative mortality. |