Clinical trial NCT03270930: Operative Duration as a Predictor of Mortality in Pediatric Emergency Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mortality
Pediatric
Laparotomy
Emergencies
Keywords: Operative duration
Pediatric surgery
Emergency laparotomy
Mortality rate
Survival
Kaplan-Meier analysis
ROC curve analysis
Senior resident
Lead sponsor: Jawaharlal Nehru Medical College
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 213
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of duration of laparotomy on pediatric post-operative mortality
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jawaharlal Nehru Medical College, Aligarh
name: Kaushal D Singh, MS Surgery
role: PRINCIPAL_INVESTIGATOR
References: