| CTRI Number |
CTRI/2024/10/075212 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Prospective Observational Study on the Appearance of Normal Bowel Sounds and the Initiation of Oral Feeding in Postoperative Patients Following Bowel Anastomosis |
|
Scientific Title of Study
|
A prospective observational study of appearance of normal bowel sound and starting
oral fluid in post operative patients following bowel anastomosis. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nithin K V |
| Designation |
Surgery Resident |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
Department of General Surgery
Sir T Hospital Bhavnagar
Gujarat
Room no 803
Pg 3 hostel
Sir T Hospital
Jail Road Bhavnagar
Kollam
KERALA
364001
India |
| Phone |
9061384052 |
| Fax |
|
| Email |
nithinkvcdlm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SMIT M MEHTA |
| Designation |
Assistant Professor |
| Affiliation |
gmc bhavnagar |
| Address |
Department of General Surgery
Sir T Hospital
Jail Road Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8905735051 |
| Fax |
|
| Email |
dr.smitmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nithin K V |
| Designation |
Surgery Resident |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
Kopparazhikathu veedu velanmukku chadayamangalam po kollam kerala
Room no 803
Pg 3 hostel
Sir T Hospital
Jail road Bhavnagar
Kollam
KERALA
691534
India |
| Phone |
9061384052 |
| Fax |
|
| Email |
nithinkvcdlm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical College bhavnagar Gujarat
India
364001 |
|
|
Primary Sponsor
|
| Name |
government medical college bhavnagar |
| Address |
Government Medical College Jailroad Kalanala Bhavnagar
Gujarat India 364001 |
| Type of Sponsor |
Government medical college |
|
|
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 Nithin K V |
Government medical College bhavnagar |
Department of Gereral Surgery
Government medical College
Jail Road
Kalanala Bhavnagar Gujarat
364001
Bhavnagar
Bhavnagar
GUJARAT |
09061384052
nithinkvcdlm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics comittee, Government medical college, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
all patients undergoing resection and anastomosis in Sir T Hospital |
|
| ExclusionCriteria |
| Details |
People having diversion procedure along with Resection and anastomosis surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the tolerance of oral feeding after resumption of normal bowel sounds in patients undergoing resection and anastomosis |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To asses the complications in post operative periods of 6 months in patients undergoing resection and anastomosis
To asses the gradual resumption of diet according to bowel sounds upto full solid oral diet. |
0 to 6 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
25/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To find out the average resumption time of normal bowel sounds and starting of oral fluids and to identify how it affects the life quality of the patient.
|