- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02882932
Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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.
Andre navn:
|
Annen: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IEC/MMIMSR/68/14
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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Kliniske studier på Super Oxidized Solution in group I
-
University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)Fullført
-
VA Office of Research and DevelopmentFullførtSchizofreni | Schizoaffektiv lidelse | Schizofreni og relaterte lidelserForente stater
-
Thammasat UniversityFullførtOsteo Artritt Kne | Kronisk knesmerter