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
|
|
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
|
|
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. |