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

24. august 2016 opdateret af: DR RIKKI SINGAL, Maharishi Markendeswar University (Deemed to be University)
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

290

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 dag til 90 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Super Oxidized Solution
Procedure/Surgery: Super Oxidized Solution(SOS) in group I - SOS with normal saline solution was used
Procedure: Super Oxidized Solution in group I
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.
Andre navne:
  • normal saltvandsopløsning
Andet: normal saline

Procedure/Surgery: normal saline

In group II - patients underwent normal saline wash and bacterial load was noted.
Procedure: Super Oxidized Solution in group I
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.
Andre navne:
  • normal saltvandsopløsning

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the investigators measured the infection rate by checking the bacterial load during after surgery
Tidsramme: average of one year
The investigators asked about the infection, early recovery
average of one year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Maharishi Markendeswar University (Deemed to be University)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2014

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. november 2015

Datoer for studieregistrering

Først indsendt

16. juli 2016

Først indsendt, der opfyldte QC-kriterier

24. august 2016

Først opslået (Skøn)

30. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IEC/MMIMSR/68/14

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Peritonitis

Kliniske forsøg med Super Oxidized Solution in group I

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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