Poppy Seed Use in Gastroenteric Fistula Diagnosis

Istanbul University

Status: Active, not recruiting

Conditions: Fistula; Gynecologic Cancers

Treatments: Diagnostic Test: computed tomography and poppy seed

Study type: Interventional

Funder types: Other

Identifiers

NCT06793657

2024/2142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

None

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Diagnostic Test: computed tomography and poppy seed