Back to resultsAcute Presentation and Management of Abdominal Tuberculosis: A Ten-year Experience at a Tertiary Care Center in Pakistan
Primary Purpose
Tuberculosis; Abdomen
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
exploratory laparotomy
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis; Abdomen
Eligibility Criteria
Inclusion Criteria:
- Both sexes and age between years and 90 years
- Patients presenting with acute abdomen and who underwent exploratory laparotomy
- Patients who diagnosis confirmed on biopsy (caseating granulomas)
Exclusion Criteria:
- Peritoneal tuberculosis
- Other causes of acute abdomen (Typhoid perforation)
- Patients diagnosed with abdominal tuberculosis and on conservative management
Sites / Locations
- Services hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exploratory Laparotomy
Arm Description
Exploratory Laparotomy of patients presenting acute abdomen and whose diagnosis later on confirmed on histopathology to be tuberculosis
Outcomes
Primary Outcome Measures
Percentage of patients who develop complications after surgery
Complications of surgery like leakage of gut content, enterocutaneous fistula, intestinal obstruction
Percentage of patients who develop recurrence of abdominal tuberculosis (elevated ESR, CT scan findings of abdominal tuberculosis)
Recurrence of abdominal tuberclosis assessed by ESR, CT scan Abdomen, Biopsy
Mortality rate
death due to postoperative complications
Secondary Outcome Measures
Full Information
NCT ID
NCT03918226
First Posted
April 15, 2019
Last Updated
April 15, 2019
Sponsor
Services Hospital, Lahore
1. Study Identification
Unique Protocol Identification Number
NCT03918226
Brief Title
Acute Presentation and Management of Abdominal Tuberculosis: A Ten-year Experience at a Tertiary Care Center in Pakistan
Official Title
Acute Presentation and Management of Abdominal Tuberculosis: A Ten-year Experience at a Tertiary Care Center in Pakistan
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2008 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective interventional study was conducted in Services Instituton of Medical Sciences all patients who underwent emergency laparotomy from 2008-2018 due to abdominal tuberculosis. Data were analyzed using SPSS version 21
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis; Abdomen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exploratory Laparotomy
Arm Type
Other
Arm Description
Exploratory Laparotomy of patients presenting acute abdomen and whose diagnosis later on confirmed on histopathology to be tuberculosis
Intervention Type
Procedure
Intervention Name(s)
exploratory laparotomy
Intervention Description
Patients presenting with acute abdomen were operated. Exploratory Laparotomy of patients was done. Further procedure was done according to peroperative findings. Ileostomy for perforation of gut, stricturoplasty for strictutre, biopsy for mesentric lymphadenopathy
Primary Outcome Measure Information:
Title
Percentage of patients who develop complications after surgery
Description
Complications of surgery like leakage of gut content, enterocutaneous fistula, intestinal obstruction
Time Frame
9 months
Title
Percentage of patients who develop recurrence of abdominal tuberculosis (elevated ESR, CT scan findings of abdominal tuberculosis)
Description
Recurrence of abdominal tuberclosis assessed by ESR, CT scan Abdomen, Biopsy
Time Frame
1 year
Title
Mortality rate
Description
death due to postoperative complications
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Both sexes and age between years and 90 years
Patients presenting with acute abdomen and who underwent exploratory laparotomy
Patients who diagnosis confirmed on biopsy (caseating granulomas)
Exclusion Criteria:
Peritoneal tuberculosis
Other causes of acute abdomen (Typhoid perforation)
Patients diagnosed with abdominal tuberculosis and on conservative management
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmmood Ayyaz, mbbs, fcps
Organizational Affiliation
Services Hospital, Lahore
Official's Role
Study Director
Facility Information:
Facility Name
Services hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Acute Presentation and Management of Abdominal Tuberculosis: A Ten-year Experience at a Tertiary Care Center in Pakistan
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