Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases

Study Overview
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Brief Summary
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Super Oxidized Solution (SOS) was used in peritonitis and results were compared by using normal saline solution in two groups. Abdominal fluid was taken to check for bacterial load after giving lavage with SOS solution and in other group normal saline. SOS is a high level disinfectant, non-flammable and no special training is required to handle it.

Detailed Description
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Aim - To investigate the efficacy of super-oxidized solution (SOS) over normal saline in peritonitis. The investigators objectives are to present the potential clinical impact of intraperitoneal lavage with solutions for early recovery of the patient by reducing the infection rate. Methods - A double-blind random clinical trial was performed in 240 patients diagnosed as peritonitis at MMIMSR, Mullana, Ambala, India, from December 2014 - November 2015. Subjects were divided into 2 groups, i.e. 120 patients in the study group and 120 cases in the control group. Both the groups underwent peritoneal lavage ; the study group received SOS where as control group underwent normal saline lavage. The effectiveness of both the solutions were compared.

Conditions
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Peritonitis

Intervention / Treatment
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* Procedure: Super Oxidized Solution in group I


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: gastric, duodenal, ileal perforation, appendicitis those patients were willing to participate and the informed consent was taken Exclusion criteria: evidence of enteric encephalopathy liver diseases renal diseases heart disease known allergy to any substance multiple trauma or organ injury any gynaecological etiology

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Super Oxidized Solution<br>Procedure/Surgery: Super Oxidized Solution(SOS) in group I - SOS with normal saline solution was used | Procedure: Super Oxidized Solution in group I<br>* Two groups were made as group I and group II. Peritoneal Lavage was given with SOS and normal saline in group I. in group II only normal saline wash was given.<br>* Other names: normal saline solution;|
| Other: normal saline<br>Procedure/Surgery: normal saline In group II - patients underwent normal saline wash and bacterial load was noted. | Procedure: Super Oxidized Solution in group I<br>* Two groups were made as group I and group II. Peritoneal Lavage was given with SOS and normal saline in group I. in group II only normal saline wash was given.<br>* Other names: normal saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the investigators measured the infection rate by checking the bacterial load during after surgery | The investigators asked about the infection, early recovery | average of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds | the condition of the patient measured in the form of early bowel sounds, fever and discharge from the operated area | With in 10 -20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peritonitis, solutions, normal saline, infection, peritoneal lavage