Trials / Completed
CompletedNCT03270930
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 213 (actual)
- Sponsor
- Jawaharlal Nehru Medical College · Academic / Other
- Sex
- All
- Age
- 5 Years – 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Emergency laparotomy | All patients in study underwent emergency laparotomy within 24 hours of presentation after adequate resuscitation of minimum 1 hour. |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2017-03-31
- Completion
- 2017-07-31
- First posted
- 2017-09-01
- Last updated
- 2017-09-12
Source: ClinicalTrials.gov record NCT03270930. Inclusion in this directory is not an endorsement.