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

Phase 3

Not yet recruiting

• Conditions: Cholelithiasis,

• Registration Number: CTRI/2020/09/028110
• Lead Sponsor: All India Institute of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-10
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.All patients undergoing elective laparoscopic cholecystectomy 2.Patients Above 18 years of age 3.Patients’ willing to participate in the study.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
1.Compare the incidence of port site hernia with and without the use of the standardized method of umbilical hygiene	1week, 2 weeks, 1 month, 3 months and 6 months.
2.Compare the incidence of port site infection with and without the use of the standardized method of umbilical hygiene	1week, 2 weeks, 1 month, 3 months and 6 months.

Secondary Outcome Measures

Name	Time	Method
To isolate organisms causing port site infections and assess their antibiotic sensitivity patterns
To identify risk factors for port site infection, wound complications and later development of a hernia

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences

🇮🇳South, DELHI, India

Richa Garg

Principal investigator

09654389799

richagarg.rg96@gmail.com