NCT03262025

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

August 23, 2017

Last Update Submit

August 24, 2017

Conditions

Keywords

Primary cecal pathologyEmergency laparotomyRuptured liver abscessRight hemicolectomyConservative colonic resectionFulminant amoebic colitisIleocecal resectionIleoascending anastomosisIleotransverse anastomosisCecal diverticulitisAmoebic typhilitisIdiopathic typhilitis

Outcome Measures

Primary Outcomes (1)

  • Pattern of primary cecal pathology in Indian setting

    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

Study Arms (4)

Operated patients who survived

Patients who were discharged in index hospital admission after operative intervention

Procedure: Operated

Operated patients who expired

Patients who expired in index hospital admission after operative intervention

Procedure: Operated

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

Interventions

OperatedPROCEDURE

Patients were either managed conservatively or underwent emergency laparotomy

Operated patients who expiredOperated patients who survived

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients presenting in the 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abdomen, AcuteDysentery, AmebicTyphlitis

Condition Hierarchy (Ancestors)

Abdominal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveIntestinal Diseases, ParasiticParasitic DiseasesInfectionsAmebiasisProtozoan InfectionsDysenteryGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesIntraabdominal InfectionsEnterocolitis, NeutropenicEnterocolitisCecal Diseases

Study Officials

  • Kaushal D Singh, MS Surgery

    Jawaharlal Nehru Medical College, Aligarh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

January 1, 2016

Primary Completion

May 31, 2017

Study Completion

July 15, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08