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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2019
Source Services Hospital, Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Services hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

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