COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE

Study Overview
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Brief Summary
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The study will be carried out in Surgical Unit-III, Lahore General Hospital, Lahore for one year . . Patients undergoing surgery for Ileostomy will be randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay.

Detailed Description
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The study will be carried out in Surgical Unit-III, Lahore General Hospital. It will be a randomized control trial. Patients undergoing surgery for Ileostomy were randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow-up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay. The data will be statistically analyzed by using SPSS v23.0.t test (independent sample) used for the comparison of hospital stay mean. Chi-square will also used for the comparison of the frequencies of SSI. Data were stratified for gender and age. A p-value ≤0.05 will be considered as significant.

Official Title
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COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE

Conditions
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Surgical Site Infection, Difference in Surgical Site Infection According to Gender and Age Groups

Intervention / Treatment
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* Procedure: Purse string closure of Ileostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: included in the study 1. Patients of both gender 2. Patients ages between 25-70 3. Patients undergoing surgery for having ileostomy for benign disease of intestine (as per operational definitions). Exclusion Criteria: Following patients were excluded 1. Patients with pre-existing stomal site wound infection 2. Reversal of stoma through laparatomy 3. Post-operative anastomotic leak 4. Ureamic patients 5. Patients on chemotherapy and radiations

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised control trial of two arms
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group B : conventional primary closure<br>allileostomies are reversed with conventional method | |
| Experimental: Group A: Purse string closure<br>the ileostomy reversal circular incision used with stitches of continuous and non-absorbable. The wound of skin was closed by using (Proline No. 1) that leaving 0.5 cm defect on middle in the skin. | Procedure: Purse string closure of Ileostomy<br>* conventional proceedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site infection | surgical site infection was graded according to southampton score grade IV and V | 14th post operative day |