- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03262025
Primary Cecal Pathologies Presenting as Acute Abdomen
Primary Cecal Pathologies Presenting as Acute Abdomen and Critical Appraisal of Their Current Management Strategies
Background: The importance of cecal pathologies lie in the fact that being the first part of large intestine, any disease involving the cecum affects overall functioning of the large bowel. Primary cecal pathologies presenting as acute abdomen have not been described in any previous study in terms of presentation, management and outcome.
Objectives: The objective of this study was to identify the reported causes of primary cecal pathologies presenting as acute abdomen and the various causes presenting in Indian setting, to discuss morbidity and mortality associated with cecal pathologies and to critically analyse the various management modalities employed in emergency setting.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All adult patients presenting in emergency department with acute abdomen were included in study in whom cecal pathology as the cause of acute abdomen was suspected clinically and/or on imaging and further confirmed per-operatively and/or on histopathological examination (HPE) or on imaging. Patients identified with primarily a cecal pathology who had acute pain abdomen as the initial symptom but who didn't presented immediately due to various reasons were also included in the study as it is a well-documented fact that patients in developing countries like India, especially those who live in rural areas or who are illiterate often resort to indigenous methods of treatment or take symptomatic treatment from local practitioners before presenting to a tertiary centre for definitive treatment. Also, only those patients who were operated within 24 hours of index admission in the emergency operation theatre (EOT) by a registrar or faculty member after initial resuscitation were included in the study.
Exclusion Criteria:
- Patients with sub-acute, intermittent or chronic pain; when predominant symptoms were attributable to some other cause even with concomitant presence of a cecal pathology; when predominant pathology was not cecal and patients with cecal pathology operated as an elective case were excluded from this study. Thus patients diagnosed to be having appendiceal stump blowout, perforation of base of appendix, ileocecal tuberculosis or intussusception were not included.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Operated patients who survived
Patients who were discharged in index hospital admission after operative intervention
|
Patients were either managed conservatively or underwent emergency laparotomy
|
|
Operated patients who expired
Patients who expired in index hospital admission after operative intervention
|
Patients were either managed conservatively or underwent emergency laparotomy
|
|
Non-operated patients who survived
Patients who were discharged in index hospital admission after being managed conservatively
|
|
|
Non-operated patients who expired
Patients who expired in index hospital admission after being managed conservatively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pattern of primary cecal pathology in Indian setting
Time Frame: 10 years
|
The objective of this study was to identify the reported causes of cecal pathology presenting as acute abdomen in medical literature and the various causes presenting in Indian setting, to identify the pattern of common pathologies in Indian setup, to discuss morbidity and mortality associated with cecal pathologies and to critically analyse the various management modalities commonly employed for cecal pathologies presenting as acute abdomen.
|
10 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Pain
- Neurologic Manifestations
- Disease Attributes
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Intestinal Diseases, Parasitic
- Parasitic Diseases
- Protozoan Infections
- Cecal Diseases
- Diverticular Diseases
- Dysentery
- Intraabdominal Infections
- Enterocolitis
- Abdominal Pain
- Enterocolitis, Neutropenic
- Emergencies
- Colitis
- Diverticulitis
- Abdomen, Acute
- Amebiasis
- Dysentery, Amebic
- Typhlitis
Other Study ID Numbers
- CecalJNMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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