NCT03918226

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

10 years

First QC Date

April 15, 2019

Last Update Submit

April 15, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Exploratory Laparotomy

OTHER

Exploratory Laparotomy of patients presenting acute abdomen and whose diagnosis later on confirmed on histopathology to be tuberculosis

Procedure: exploratory laparotomy

Interventions

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

Exploratory Laparotomy

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Peritoneal tuberculosis
  • Other causes of acute abdomen (Typhoid perforation)
  • Patients diagnosed with abdominal tuberculosis and on conservative management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Laparotomy

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Mahmmood Ayyaz, mbbs, fcps

    Services Hospital, Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 17, 2019

Study Start

May 1, 2008

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations