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临床试验/NCT06793657
NCT06793657进行中(未招募)不适用

Poppy Seed Use in Gastroenteric Fistula Diagnosis in Gynecologic Oncology Surgery

Istanbul University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
sensitivity, specificity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: computed tomography and poppy seed (Diagnostic Test)

结局指标

主要结局

sensitivity, specificity

时间窗: Two years

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.

positive and negative predictive values

时间窗: Two years

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Albayrak

Principal Investigator

Istanbul University

研究点 (1)

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