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CTRI Number  CTRI/2024/05/068092 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [sham feeding using chewing gum in reducing the duration of post operative ileus.]  
Study Design  Other 
Public Title of Study   Efficacy of sham feeding using chewing gum in reducing the duration of post operative ileus. 
Scientific Title of Study   To study the efficacy of sham feeding using chewing gum in reducing the duration of post operative ileus following gastrointestinal surgeries A randomised control study 
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 Nirmalkumar U 
Designation  PG Resident (Department of General Surgery ) 
Affiliation  Sri Manakula Vinayagar Medical college and Hospital 
Address  Department of General Surgery. Sri Manakula Vinayagar Medical college and Hospital Kalitheerthalkuppam Pondicherry

Pondicherry
PONDICHERRY
605107
India 
Phone  7708446688  
Fax    
Email  nirmal.unk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajavel 
Designation  Professor (Department of General Surgery ) 
Affiliation  Sri Manakula Vinayagar Medical college and Hospital 
Address  Department of General Surgery Sri Manakula Vinayagar Medical college and Hospital kalitheerthalkuppam Pondicherry

Pondicherry
PONDICHERRY
605107
India 
Phone  9940907017  
Fax    
Email  rajavelmathi@rocketmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nirmalkumar U 
Designation  PG Resident (Department of General Surgery ) 
Affiliation  Sri Manakula Vinayagar Medical college and Hospital 
Address  Department of General Surgery Sri Manakula Vinayagar Medical college and Hospital kalitheerthalkuppam Pondicherry

Pondicherry
PONDICHERRY
605107
India 
Phone  7708446688  
Fax    
Email  nirmal.unk@gmail.com  
 
Source of Monetary or Material Support  
Sri Manakula Vinayagar Medical college and Hospital Kalitheerthalkuppam Pondicherry 605107 India 
 
Primary Sponsor  
Name  Sri Manakula Vinayagar Medical college and hospital 
Address  Sri Manakula Vinayagar Medical college and hospital Kalitheerthalkuppam Pondicherry 605107 India 
Type of Sponsor  Private medical college 
 
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 Nirmalkumar   Sri Manakula Vinayagar Medical college and Hospital  Department of General Surgery
Pondicherry
PONDICHERRY 		 7708446688

nirmal.unk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Manakula Vinayagar Medical College and Hospital - Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sham feeding using CHEWING GUM (Wrigley sugar free chewing gum) in reducing the duration and management of post operative ileus following gastrointestinal surgeries.  Patients will receive intervention (Wrigley sugarfree chewing gum) starting from SIX HOURS POST SURGERY THREE TIMES A DAY EACH TIME FOR 15 MINUTES UNTIL TIME OF PASSSAGE OF FIRST FLATUS.Stratified randomisation will be done and partcipants coming under Group A,C- gum chewing group ( both elective and emergency ) will come under intervention group (will receive chewing gum) ( Chewing gum – Wrigleys sugar free chewing gum , Flavour – spearmint , sugar content -nil , 5 calorie-)Only 1 brand of chewing gum with same flavor and same nutrient value will be used for all study patients.Outcome will be recorded by the nursing staff (time of passage of first flatus) in the case report form. An outcome assessor who will be blinded from the treatment assignment will assess every patients bowel sound using a stethoscope three times per days beginning at 6 hours after surgery.All patients will be instructed to notify the nursing ward staff immediately when the first passage of flatus has occured.  
Comparator Agent  standard conventional care in the management of post operative ileus.  Patients will receive standard conventional care(comparator) starting from six hours post surgery until time of passage of first flatus.Stratified randomisation will be done and patients from Group B,D-non chewing group (both elective and emergency) will come under comparator group and will receive standarad conventional carein the management of post operative ileus.The outcome will be recorded by the nursing staff (time of passage of first flatus) in the case report form. All patients will receive same post operative feeding regimen based on auscultatory bowel sounds sips of water and diet will be started as tolerated.An outcome assessor who will be blinded from the treatment assignment will assess every patients bowel sound using a stethoscope three times per days beginning at 6 hours after surgery.All patients will be instructed to notify the nursing ward staff immediately when the first passage of flatus has occured.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of age more than 18 years and less than 65 years.
Patient undergoing open gastrointestinal surgeries both elective and emergency.
Patient requiring NPO following gastrointestinal surgeries. 
 
ExclusionCriteria 
Details  Patient swith documented allergies to content of chewing gum.
Patient who will be unconscious or unable to chew gum after 24 hours post surgery.
Patients of age less than 18 years
Patient who refuse to participate in trials.
Patients with defective or incomplete chewing movements and no teeth.
Patient undergoing laparoscopic gastrointestinal surgeries.
Patient undergoing bowel resection and anastomosis.
Patients with ongoing sepsis will not be included in the study.
Polytrauma patients will not be included in the study. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is time to first passage of flatus.  The primary outcome will be assesed starting from six hours post surgery till passage of first flatus. 
 
Secondary Outcome  
Outcome  TimePoints 
time of tolerating normal diet  will be assesed starting from six hours post surgery till time to tolerate normal diet. 
duration & course of hospital stay.  will be assesed starting from the day of admission of patient to day of discharge. 
time of first auscultatory bowel sounds.  first auscultatory bowel sounds will be assesed three times a day starting from six hours post surgery. 
time to passage of first stools  will be assesed from immediate post surgery till passage of first stools. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 3 
Date of First Enrollment (India)   10/06/2024 
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="1"
Months="0"
Days="0" 
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   Post operative ileus is the temporrary inhibition of gastro intestinal motility due to non mechanical causes.Occuring after abdominal surgeries,particularly after handling the bowel,it may resultin nausea,vomitting and anorexia.Itssequel include malnutrition,dehydration,electrolyte imbalance and aspiration pneumonia.Post operative ileus poses a significant socio economic impact by prolonging hospital stay by as much as 5 days per patient. Chewing gum ,alongside other multipronged approaches recognised by Enhanced recovery after surgery (ERAS) society, is thought to stimualte sham feeding which may stimulate gastrointestinal recovery post opertaively by the activation of cephalic-vagal axis.Additionally , many practitioners are reluctant to institute early feeding in some cases due to fears over safety and potential complications.Sham feeding could therefore be considered a safer alternative to early enteral nutrition in reducing post operative ileus.The aim of this study is to compare the efficacy of sham feeding using chewing to standard conventional care in the management of post operative illness in adults undergoing gastrointestinal surgeries.Participants who met exclusion and inclusion criteria were stratified into two strata emergency and elective gastrointestinal surgeries and simple randomisation is performed and participants were allocated into chewing and non chewing group.The interventional group(chewing group) receieved sham feeding using chewing gum (wrigleys sugar free chewing gum - spearmint flavor,5 calories) 6 hours after surgery three times a days each time for 15 minutes until time to passage of first flatus and the other group non chewing group receieved standard conventional management of postoperative ileus.All patients will receive same post operative feeding regimen based on ausculatatory bowel sounds sips of water will started and diet will be started as tolerated.The primary outcome of study is time to first passage of flatus.secondary outcomes are time to first ausculattory bowel sounds,time of tolerating normal diet,time to first passage of stools,duration and course of hospital stay. 
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