MortalityNCT03270930
Operative Duration as a Predictor of Mortality in Pediatric Emergency Surgery
An observational study of Mortality and Pediatric, run by Jawaharlal Nehru Medical College.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Mortality, Pediatric, Laparotomy
- What is being tested?
- Emergency laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 31 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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
- Mortality, Pediatric, Laparotomy, Emergencies
- Being tested
- Emergency laparotomy
- Keywords
- Operative duration, Pediatric surgery, Emergency laparotomy, Mortality rate, Survival, Kaplan-Meier analysis, ROC curve analysis, Senior resident
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency laparotomyProcedure or surgery
All patients in study underwent emergency laparotomy within 24 hours of presentation after adequate resuscitation of minimum 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Emergency laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Apr 2015
- Primary completion31 Mar 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jawaharlal Nehru Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaushal Deep Singh, Jawaharlal Nehru Medical College
- Investigators
- Kaushal D Singh, MS Surgery, Principal investigator, Jawaharlal Nehru Medical College, Aligarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270930
- Sponsor's protocol ID
- JNMCH
- Status last verified
- Sep 2017
- First submitted
- 23 Aug 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03270930
- Acronym / sponsor ID
- JNMCH
- Conditions
- Mortality, Pediatric, Laparotomy, Emergencies
- Keywords
- Operative duration, Pediatric surgery, Emergency laparotomy, Mortality rate, Survival, Kaplan-Meier analysis, ROC curve analysis, Senior resident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Jawaharlal Nehru Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survived | – | Procedure: Emergency laparotomyPediatric 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 |
| Expired | – | Procedure: Emergency laparotomyPediatric 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 |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency laparotomyAll patients in study underwent emergency laparotomy within 24 hours of presentation after adequate resuscitation of minimum 1 hour. | Procedure or surgery | Expired, Survived |
Primary outcome
Effect of duration of laparotomy on pediatric post-operative mortality
Time frame: 24 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: 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.
Related trials for Mortality
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
Enrolling by invitation
Accelerating Maternal and Newborn Survival: The AMANI Study
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaushal D Singh, MS Surgery principal investigator
Jawaharlal Nehru Medical College, Aligarh
Questions about this trial
What is this clinical trial studying?
An observational study of Mortality and Pediatric, run by Jawaharlal Nehru Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of duration of laparotomy on pediatric post-operative mortality (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.