Acute AbdomenNCT03262025
Primary Cecal Pathologies Presenting as Acute Abdomen
An observational study of Acute Abdomen and Emergency Surgery, run by Jawaharlal Nehru Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Abdomen, Emergency Surgery, Laparotomy
- What is being tested?
- Operated
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 15 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
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 often pose a challenge to their optimal management due to requirement of urgent intervention in most cases and being a common source of misdiagnosis. These pathologies often mimic acute appendicitis and commonly misdiagnosed as one. This misdiagnosis can lead to under-treatment of the underlying pathology and this results in high morbidity and mortality associated with these conditions. So the accurate identification of such conditions is required so that the patients can be optimally managed and patient outcome can be improved.
- Conditions
- Acute Abdomen, Emergency Surgery, Laparotomy, Amoebic Colitis, Diverticulitis of Caecum, Typhlitis
- Being tested
- Operated
- Keywords
- Primary cecal pathology, Emergency laparotomy, Ruptured liver abscess, Right hemicolectomy, Conservative colonic resection, Fulminant amoebic colitis, Ileocecal resection, Ileoascending anastomosis, Ileotransverse anastomosis, Cecal diverticulitis, Amoebic typhilitis, Idiopathic typhilitis
- Medical subject headings
- Abdomen, Acute, Dysentery, Amebic, Typhlitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OperatedProcedure or surgery
Patients were either managed conservatively or underwent emergency laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Operated patients who survived | Patients who were discharged in index hospital admission after operative intervention Receives: Procedure: Operated | |
| Operated patients who expired | Patients who expired in index hospital admission after operative intervention Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Jan 2016
- Primary completion31 May 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AbdomenStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 43 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
- NCT03262025
- Sponsor's protocol ID
- CecalJNMC
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared on request for multi-institutional prospective studies.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Cecal Pathologies Presenting as Acute Abdomen and Critical Appraisal of Their Current Management Strategies
- ClinicalTrials.gov ID
- NCT03262025
- Acronym / sponsor ID
- CecalJNMC
- Conditions
- Acute Abdomen, Emergency Surgery, Laparotomy, Amoebic Colitis, Diverticulitis of Caecum, Typhlitis
- Keywords
- Primary cecal pathology, Emergency laparotomy, Ruptured liver abscess, Right hemicolectomy, Conservative colonic resection, Fulminant amoebic colitis, Ileocecal resection, Ileoascending anastomosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Jawaharlal Nehru Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 25 Aug 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.
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.
Detailed description
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 often pose a challenge to their optimal management due to requirement of urgent intervention in most cases and being a common source of misdiagnosis. These pathologies often mimic acute appendicitis and commonly misdiagnosed as one. This misdiagnosis can lead to under-treatment of the underlying pathology and this results in high morbidity and mortality associated with these conditions. So the accurate identification of such conditions is required so that the patients can be optimally managed and patient outcome can be improved.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Operated patients who survived | – | Procedure: OperatedPatients who were discharged in index hospital admission after operative intervention |
| Operated patients who expired | – | Procedure: OperatedPatients who expired in index hospital admission after operative intervention |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| OperatedPatients were either managed conservatively or underwent emergency laparotomy | Procedure or surgery | Operated patients who expired, Operated patients who survived |
Primary outcome
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.
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 25 Aug 2017.
- Individual participant dataSharing planned: Undecided. Data can be shared on request for multi-institutional prospective studies.
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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 Acute Abdomen and Emergency Surgery, 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 25 Aug 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?
Pattern of primary cecal pathology in Indian setting (time frame: 10 years). 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 25 Aug 2017.