Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Super Oxidized Solution
Procedure/Surgery: Super Oxidized Solution(SOS) in group I - SOS with normal saline solution was used
|
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.
다른 이름들:
|
|
다른: normal saline
Procedure/Surgery: normal saline In group II - patients underwent normal saline wash and bacterial load was noted. |
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
the investigators measured the infection rate by checking the bacterial load during after surgery
기간: average of one year
|
The investigators asked about the infection, early recovery
|
average of one year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds
기간: With in 10 -20 days
|
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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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