Acute Presentation and Management of Abdominal Tuberculosis: A Ten-year Experience at a Tertiary Care Center in Pakistan

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

Study Overview

• Status: Completed
• Conditions: Tuberculosis; Abdomen
• Intervention / Treatment: Procedure: exploratory laparotomy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Services Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exploratory Laparotomy; Exploratory Laparotomy of patients presenting acute abdomen and whose diagnosis later on confirmed on histopathology to be tuberculosis	Procedure: exploratory laparotomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who develop complications after surgery	Complications of surgery like leakage of gut content, enterocutaneous fistula, intestinal obstruction	9 months
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	1 year
Mortality rate	death due to postoperative complications	9 months

Collaborators and Investigators

• Sponsor: Services Hospital, Lahore

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2008
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: S16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No