Emergencies Clinical Trial
Official title:
A Prospective Study of Evaluation of Operative Duration as a Predictor of Mortality in Pediatric Emergency Surgery: Concept of 100 Minutes Laparotomy in Resource-limited Setting
Verified date | September 2017 |
Source | Jawaharlal Nehru Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Introduction Operative duration is an important but under-studied predictor of mortality in
emergency laparotomies.
Aims & Objectives The objective of this study was to quantify the effect of duration of
emergency laparotomy in children on mortality and to identify a rough cut-off duration of
laparotomy to serve as a guide to plan the laparotomy to optimize pediatric surgical patient
outcome.
Status | Completed |
Enrollment | 213 |
Est. completion date | July 31, 2017 |
Est. primary completion date | March 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 10 Years |
Eligibility |
Inclusion Criteria: - All pediatric patients in the age group of 5 to 10 years presenting with acute abdomen diagnosed clinically and radiologically to be having a diagnosis of secondary peritonitis and obstruction; who were adequately resuscitated (with a minimum resuscitation period of at least 1 hour) pre-operatively and underwent definitive surgery by a single surgeon (pediatric surgery senior resident) in the emergency were included in the study. Also, only those patients who had a PRISM-III (Pediatric Risk of Mortality III) score (Figure 1) of = 8 at presentation were included to avoid the confounding effect of pre-operative variables that might affect mortality. All patients were adequately resuscitated in terms of temperature, central nervous system (Glasgow Coma Scale, pupillary reflexes), cardiovascular system (systolic blood pressure, heart rate) and respiratory system (oxygen saturation > 95%, pCO2 , pH, PaO2) parameters so that the patients were brought within 0 score range of PRISM-III score at the end of resuscitation and before shifting to the operation theatre. Furthermore for inclusion only those pediatric patients were considered who presented within 72 hours of initial onset of symptoms, operated within 24 hours of initial presentation and who died in index hospital admission within 30 days. Exclusion Criteria: - Patients who underwent damage control surgery, whose PRISM - III score was >9 at any point of time before undergoing laparotomy or inability to achieve adequate resuscitation (PRISM-III score >0 before shifting to operation theatre) and/or requirement of resuscitation beyond 4 hours of presentation were excluded from the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Jawaharlal Nehru Medical College |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of duration of laparotomy on pediatric post-operative mortality | This study primarily quantified the effect of duration of emergency laparotomy in children on mortality and also identified a rough cut-off duration of laparotomy as 100 minutes that such a laparotomy can be planned to optimize pediatric surgical patient out come in terms of decreased mortality. | 24 months |
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