Operative Duration as a Predictor of Mortality in Pediatric Emergency Surgery

NCT03270930 | Completed DMC

• 1 other identifier: JNMCH
• Study Type: observational
• Target: 213
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mortality; Pediatric; Laparotomy; Emergencies

Keywords

Operative duration; Pediatric surgery; Emergency laparotomy; Mortality rate; Survival; Kaplan-Meier analysis; ROC curve analysis; Senior resident

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Emergency laparotomy PROCEDURE

All patients in study underwent emergency laparotomy within 24 hours of presentation after adequate resuscitation of minimum 1 hour.

Expired; Survived

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jawaharlal Nehru Medical College: lead

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaushal D Singh, MS Surgery

  Jawaharlal Nehru Medical College, Aligarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: September 1, 2017
• Study Start: April 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: July 31, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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