CTRI Number	CTRI/2010/091/003023 [Registered on: 17/01/2011]
Last Modified On:
Post Graduate Thesis
Type of Trial
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.
Secondary IDs if Any	Secondary ID  Registry  213  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr R C Mistry  Address  Tata Memorial Hospital Parel, Mumbai Mumbai MAHARASHTRA 400012 India  Phone  022-24177000   Fax  022-24168604   Email  mistryrc@tmcmail.org
Details Contact Person Scientific Query	Name  Dr C S Pramesh  Address  Tata Memorial Hospital Parel, Mumbai Mumbai MAHARASHTRA 400012 India  Phone  022-24177070   Fax  022-24168604   Email  cspramesh@gmail.com
Details Contact Person Public Query	Name  Dr C S Pramesh  Address  Tata Memorial Hospital Parel, Mumbai Mumbai MAHARASHTRA 400012 India  Phone  022-24177070   Fax  022-24168604   Email  cspramesh@gmail.com
Source of Monetary or Material Support	Tata Memorial Hospital, Mumbai
Primary Sponsor	Name  Tata Memorial Hospital  Address    Type of Sponsor
Details of Secondary Sponsor	Name  Address  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr C S Pramesh  Tata Memorial Hospital  Dr E. Borges Road,Parel-400012 Mumbai   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
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition    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
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.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Centralized
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  1. Pulmonary Complications 2. Anastomotic leak
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.
Target Sample Size	Total Sample Size="150" Sample Size from India=""
Phase of Trial	Phase 2
Date of First Enrollment (India)	No Date Specified
Date of First Enrollment (Global)	13/10/2006
Estimated Duration of Trial	Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)	Completed
Recruitment Status of Trial (India)
Publication Details
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.