Poppy Seed Use in Gastroenteric Fistula Diagnosis

NCT ID: NCT06793657

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-06-30

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.

Detailed Description

Gastrointestinal fistulas are pathologic epithelial bridgings and connections between various loops or intestines and abdominal cavity, bladder, vagina, skin or any other organ. Fistulas are potentially dangerous since they may cause electrolyte imbalance, sepsis and abscesses and malnutrition. However, their diagnosis may not be easy since the sensitivity of the abdominopelvic computed tomography scan with oral, ıntravenous and rectal contrast is around 60% percent which is low for such an life threatening emergency. In gynecologic oncology large and small intestine procedures including resection and anastomoses are frequently performed. These procedures may rise suspicions the integrity of anastomoses and may lead to dilemma to intervene or not in case of a diversion from usual clinical progress. Poppy seed ( pappaver somniferum) is a small (about 1 mm each), non digestible cultivable plant seed used in various foods. It is innocent and does not contain any opium or related ingredient. When ingested with yogurt or soup in small amounts it is not absorbed or ingested within intestine and appears as small gray-blue small spheric seed in abdominal drains, vaginal fluid, urine or skin depending on the fistula formation. Poppy seed was first used in diagnosis of intestinal fistulas by Lippert et al. in 1984. Various studies followed in various fields of surgical medicine. However, there have been no reported studies using poppy seen in diagnosis of enteric fistulas in gynecologic oncology practice.

The aim of the present study is to compare the diagnostic efficacy of orally ingested poppy seed and computed tomography in diagnosis of fistulas related to gynecologic malignancies.

Conditions

Gynecologic Cancers; Fistula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

computed tomography and poppy seed

Intervention Type: DIAGNOSTIC_TEST

comparison of both interventions

Interventions

computed tomography and poppy seed

comparison of both interventions

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

computed tomography; oral poppy seed

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

None

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• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Albayrak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 34791866 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11458060 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19616793 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16519642 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18289575 (View on PubMed)

Other Identifiers

2024/2142

Identifier Type: -

Identifier Source: org_study_id