Poppy Seed Use in Gastroenteric Fistula Diagnosis

NCT06793657 | Active Not Recruiting DMC

• 1 other identifier: 2024/2142
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective of the present study is to compare the diagnostic efficacy of oral poppy seed ingestion versus the classic abdominopelvic computed tomography scan with oral, ıntravenous and rectal contrast in diagnosis of gastrointestinal fistulas in gynecologic oncology practice.

Conditions

Gynecologic Cancers; Fistula

Outcome Measures

Primary Outcomes (2)

• sensitivity, specificity

  A single arm study that will compare computed tomography and oral poppy seed in diagnosis of enteric fistulas to various organs. Both methods will be used in the same patient.

  Two years

• positive and negative predictive values

  A single arm study that will compare computed tomography and oral poppy seed in diagnosis of enteric fistulas to various organs. Both methods will be used in the same patient.

  Two years

Study Arms (1)

Single arm study for comparison of computed tomography and oral poppy seed ingestion in fistula

EXPERIMENTAL

Single arm study for comparison of computed tomography and oral poppy seed ingestion in fistula diagnosis.

Diagnostic Test: computed tomography and poppy seed

Interventions

computed tomography and poppy seed DIAGNOSTIC_TEST

comparison of both interventions

Also known as: computed tomography, oral poppy seed

Single arm study for comparison of computed tomography and oral poppy seed ingestion in fistula

Eligibility Criteria

• Gender Eligibility Details: gynecologic oncology patients
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pre and postsurgical gynecologic oncology patients who were suspected to have fistulas connecting gastrointestinal system and skin, bladder, vagina.

You may not qualify if:

• None

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Med Fac Dept. of Obstet and Gynecol. Division of Gynecologic Oncology

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Zizzo M, Tumiati D, Bassi MC, Zanelli M, Sanguedolce F, Porpiglia F, Fiori C, Campobasso D, Castro Ruiz C, Bergamaschi FA, Maestroni UV, Carrieri G, Cormio L, Biolchini F, Palicelli A, Soriano A, Sassatelli R, Ascani S, Annessi V, Giunta A. Management of colovesical fistula: a systematic review. Minerva Urol Nephrol. 2022 Aug;74(4):400-408. doi: 10.23736/S2724-6051.21.04750-9. Epub 2021 Nov 18.

  PMID: 34791866 RESULT

• Schwaibold H, Popiel C, Geist E, Hartung R. Oral intake of poppy seed: a reliable and simple method for diagnosing vesico-enteric fistula. J Urol. 2001 Aug;166(2):530-1. doi: 10.1016/s0022-5347(05)65976-9.

  PMID: 11458060 RESULT

• Melchior S, Cudovic D, Jones J, Thomas C, Gillitzer R, Thuroff J. Diagnosis and surgical management of colovesical fistulas due to sigmoid diverticulitis. J Urol. 2009 Sep;182(3):978-82. doi: 10.1016/j.juro.2009.05.022. Epub 2009 Jul 18.

  PMID: 19616793 RESULT

• Wensky H, Jongen J. Diagnosis of enterovesical fistula using poppy seeds. Colorectal Dis. 2006 Jan;8(1):71-2. doi: 10.1111/j.1463-1318.2005.00902.x. No abstract available.

  PMID: 16519642 RESULT

• Kwon EO, Armenakas NA, Scharf SC, Panagopoulos G, Fracchia JA. The poppy seed test for colovesical fistula: big bang, little bucks! J Urol. 2008 Apr;179(4):1425-7. doi: 10.1016/j.juro.2007.11.085. Epub 2008 Mar 4.

  PMID: 18289575 RESULT

MeSH Terms

Conditions

Fistula

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single arm study that will compare computed tomography and oral poppy seed in diagnosis of enteric fistulas to various organs. Both methods will be used in the same patient. Diagnostic performance of both methods will be compared in terms of sensitivity, specifity, positive and negative predictive values.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: January 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)