Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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.
Andra namn:
|
|
Övrig: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
the investigators measured the infection rate by checking the bacterial load during after surgery
Tidsram: average of one year
|
The investigators asked about the infection, early recovery
|
average of one year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IEC/MMIMSR/68/14
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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