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CTRI Number  CTRI/2020/09/028110 [Registered on: 28/09/2020] Trial Registered Prospectively
Last Modified On: 25/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study whether pre-operative bathing with special emphasis on umbilicus cleaning and later on, cleaning with coconut oil decreases incidence of port site infection, wound complications and further development of hernias in patients undergoing laparoscopic cholecystectomy 
Scientific Title of Study   A Randomized controlled study to assess the efficacy of using uniform umbilical hygiene preoperatively to reduce incidence of umbilical port site complications postoperatively in patients undergoing laparoscopic cholecystectomy  
Trial Acronym  UUH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Richa Garg 
Designation  Junior Resident 
Affiliation  AIIMS, Delhi 
Address  Surgery office first floor, CMET Building, Near BB Dikshit Library, Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9654389799  
Fax    
Email  richagarg.rg96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Yashwant S Rathore 
Designation  Associate Professor 
Affiliation  AIIMS, Delhi 
Address  Surgery office, first floor, CMET Building, Near, BB Dikshit Library, Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9911337726  
Fax    
Email  dryashvant.r@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yashwant S Rathore 
Designation  Associate Professor 
Affiliation  AIIMS, Delhi 
Address  Surgery office first floor, CMET Building, Near BB Dikshit Library, Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9911337726  
Fax    
Email  dryashvant.r@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  All India Institute of Medical Sciences, New Delhi 
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 
Richa Garg  All India Institute of Medical Sciences  AB7, C7 and D7 ward, 7th floor, Department of Surgical Disciplines
South
DELHI 
09654389799

richagarg.rg96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee for Postgraduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Arm  Bath on the morning of the surgery and clean umbilicus with running water.  
Intervention  Standardized umbilical hygiene  Bath with special emphasis to clean the umbilicus. Following that, umbilicus will be cleaned with a coconut oil soaked swab in the evening and it will be left in situ. On the morning of the surgery, a coconut oil soaked swab will be removed and advise will be given to take a bath and clean umbilicus with running water.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. All patients undergoing elective laparoscopic cholecystectomy
2. Patients Above 18 years of age
3. Patients’ willing to participate in the study
 
 
ExclusionCriteria 
Details  1. Patient not giving consent to participate in the study
2. Patients undergoing emergency cholecystectomy
3. Patients unfit for surgery
4. Patient below 18years of age
5. Patients with pre-existing umbilical hernia
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Compare the incidence of port site hernia with and without the use of the standardized method of umbilical hygiene
2. Compare the incidence of port site infection with and without the use of the standardized method of umbilical hygiene
3. Compare the incidence of wound complication with and without the use of the standardized method of umbilical hygiene
 
1week, 2 weeks, 1 month, 3 months and 6 months.  
 
Secondary Outcome  
Outcome  TimePoints 
To identify risk factors for port site infection, wound complications and later development of a hernia
 
1week, 2 weeks, 1 month, 3 months and 6 months.  
To isolate organisms causing port site infections and assess their antibiotic sensitivity patterns
 
1week, 2 weeks, 1 month, 3 months and 6 months.  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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/ Phase 4 
Date of First Enrollment (India)   01/10/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Laparoscopic cholecystectomies are the bread and butter of general surgeons. Many studies have been conducted on pre-operative skin preparation techniques to decrease risk of surgical site infection but none of the study have exclusively focussed on umbilicus cleaning. It’s a commonly missed area during bathing and harbours many resident microflora which can be a potential source of infection. That’s why our study will be focussing exclusively on pre-operative bathing with special emphasis on umbilicus cleaning and later on, cleaning with coconut oil and seeing whether it decreases incidence of port side infection, wound complications and further development of hernias.

 
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