Tuberculosis; Abdomen Clinical Trial
Official title:
Acute Presentation and Management of Abdominal Tuberculosis: A Ten-year Experience at a Tertiary Care Center in Pakistan
| NCT number | NCT03918226 |
| Other study ID # | s16 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 1, 2008 |
| Est. completion date | April 30, 2018 |
| Verified date | April 2019 |
| Source | Services Hospital, Lahore |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | April 30, 2018 |
| Est. primary completion date | April 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Pakistan | Services hospital | Lahore | Punjab |
| Lead Sponsor | Collaborator |
|---|---|
| Services Hospital, Lahore |
Pakistan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of patients who develop complications after surgery | Complications of surgery like leakage of gut content, enterocutaneous fistula, intestinal obstruction | 9 months | |
| Primary | 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 | |
| Primary | Mortality rate | death due to postoperative complications | 9 months |