An observational study in Mortality, Pediatric and Laparotomy, sponsored by Jawaharlal Nehru Medical College. Completed. Open to participants aged 5 Years to 10 Years. Per ClinicalTrials.gov, last updated 2017-09-12.
Sponsored by Jawaharlal Nehru Medical College · 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.
Operative duration has been found to affect post-operative mortality rates. Operative duration has been studied in various studies as a risk factor for predicting morbidity and several other post-operative complications like pneumonia. However, the direct effect of operative duration on mortality has been studied sparingly and that too mainly in elective setting and other authors. Thus, operative duration is an under-studied risk factor in predicting mortality in emergency laparotomies. No study was found during literature review which predicted mortality as a function of operative duration in emergency laparotomies. Most studies focused on pre-operative factors and post-operative management for predicting laparotomy outcomes like the use of POSSUM (Physiological and Operative Severity Score for the enumeration of Mortality and morbidity) score. Thus, no clear-cut recommendation exists regarding the optimal time duration for an emergency laparotomy in pediatric population beyond which a laparotomy must not proceed as it would significantly increase the mortality rate.
The primary objectives of the study were 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 so that such a laparotomy can be planned to optimize pediatric surgical patient out come in terms of decreased mortality. The secondary objectives included identifying factors that increase the time of emergency laparotomy and identifying measures that could be applied to reduce the time of laparotomy significantly and improve outcome.
Jawaharlal Nehru Medical College is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All pediatric patients presenting to our emergency department 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.
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Exclusion Criteria:
Pediatric patients in the age group of 5 to 10 years presenting with acute abdomen and undergoing emergency laparotomy who survived during their index 30-day hospital stay
Procedure: Emergency laparotomy
Pediatric patients in the age group of 5 to 10 years presenting with acute abdomen and undergoing emergency laparotomy who expired during their index 30-day hospital stay
Procedure: Emergency laparotomy
All patients in study underwent emergency laparotomy within 24 hours of presentation after adequate resuscitation of minimum 1 hour.
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.
Time frame: 24 months
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All the statistics of the patients like age, sex, operative duration, PRISM-III scores, duration of transfer to operation theatre and the final outcome will be shared.
Supporting information: Study protocol, Clinical study report
Time frame: Data will be available in the next 6 months and will be available for unlimited period of time
Access criteria: Anyone can access the data here
Data sharing details ↗ · www.researchgate.net
Ran from Apr 2015 to primary completion in Mar 2017, 23 months.
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Jawaharlal Nehru Medical College