Operative Duration as a Predictor of Mortality in Pediatric Emergency Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Emergencies; Mortality; Laparotomy; Pediatric
• Intervention / Treatment: Procedure: Emergency laparotomy

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.

• Study Type: Observational
• Enrollment (Actual): 213

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Survived; 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; All patients in study underwent emergency laparotomy within 24 hours of presentation after adequate resuscitation of minimum 1 hour.
Expired; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jawaharlal Nehru Medical College

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 11, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Survival; Operative duration; Pediatric surgery; Emergency laparotomy; Mortality rate; Kaplan-Meier analysis; ROC curve analysis; Senior resident
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: JNMCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available in the next 6 months and will be available for unlimited period of time
• IPD Sharing Access Criteria: Anyone can access the data here
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No