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CTRI Number  CTRI/2024/08/073012 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   The Role of Chewing Gum in Enhancing Bowel Recovery After Spine Operations 
Scientific Title of Study   The use of chewing gum to enhance recovery of bowel function after Spine surgery: A randomised controlled trial 
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 Bharat R Dave 
Designation  Principal Investigator and Spine Surgeon 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  Room No-9, 2nd floor Annexe , Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India

Ahmadabad
GUJARAT
380006
India 
Phone  9825019913  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharat R Dave 
Designation  Principal Investigator and Spine Surgeon 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  Room No-9, 2nd floor Annexe , Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India


GUJARAT
380006
India 
Phone  9825019913  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharat R Dave 
Designation  Principal Investigator and Spine Surgeon 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  Room No-9, 2nd floor Annexe , Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India


GUJARAT
380006
India 
Phone  9825019913  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Source of Monetary or Material Support  
Room no. 9,second floor annexe , Research department ,Stavya spine hospital and Research institute,Ellisbridge,Mithakhali. 
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  Room No-9, 2nd floor Annexe , Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat R Dave  Stavya Spine Hospital & Research Institute  Room no. 8, second floor Annexe,Department-Research department. Stavya spine hospital and Research Institute,Ellisbridge,Mithakhali. Ahmadabad ,GUJARAT,India,380006
Ahmadabad
GUJARAT 		 9825019913
07926408174
brd_172@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Stavya Spine hospital & Research Institute IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M508||Other cervical disc disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  100 consecutive patients admitted at our center undergoing single level spinal fusion will be enrolled for the study 
 
ExclusionCriteria 
Details  Patients with Cauda Equina Syndrome

Patients with pre-operative constipation

Patients who underwent previous bowel surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Postoperative analysis of 100 patients undergoing lumbar spine fusion at a single level in the post operative period.  No further follow up visit is required. 
 
Secondary Outcome  
Outcome  TimePoints 
Statistical & accessory noninvasive information which will be collected as found additionally of importance.  No further follow up is required. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   09/09/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  
This is a single center prospective observational study. 100 consecutive patients undergoing fusion of the lumbar spine at a single level will be recruited. They will be randomly allotted to the control or interventional group by computer generated randomization. The control group will undergo routine post operative care, while the intervention group will be given sham feeding with chewing gum. Post surgery, the patients will be evaluated immediately post operatively, at one hour post surgery, six hours post surgery, 12 hours post surgery and at twenty four hours post surgery. Relevant outcome measure data will be collected and recorded on Microsoft Excel.
 
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