Gynecologic CancersNCT06793657
Poppy Seed Use in Gastroenteric Fistula Diagnosis
A study testing computed tomography and poppy seed in people with Gynecologic Cancers and Fistula, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gynecologic Cancers, Fistula
- What is being tested?
- computed tomography and poppy seed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pre and postsurgical gynecologic oncology patients who were suspected to have fistulas connecting gastrointestinal system and skin, bladder, vagina.
Who cannot join
- None
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Med Fac Dept. of Obstet and Gynecol. Division of Gynecologic Oncology
Istanbul
About this study
Official title: Poppy Seed Use in Gastroenteric Fistula Diagnosis in Gynecologic Oncology Surgery
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.
Read the 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
- Being tested
- computed tomography and poppy seed
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomography and poppy seedDiagnostic test
Also called computed tomography, oral poppy seed
comparison of both interventions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: computed tomography and poppy seed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Jan 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancersStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Albayrak, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793657
- Sponsor's protocol ID
- 2024/2142
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34791866Schwaibold 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.
PubMed 11458060Melchior 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.
PubMed 19616793Wensky 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.
PubMed 16519642Kwon 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.
PubMed 18289575
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poppy Seed Use in Gastroenteric Fistula Diagnosis in Gynecologic Oncology Surgery
- ClinicalTrials.gov ID
- NCT06793657
- Acronym / sponsor ID
- 2024/2142
- Conditions
- Gynecologic Cancers, Fistula
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single arm study for comparison of computed tomography and oral poppy seed ingestion in fistula | Experimental | Diagnostic Test: computed tomography and poppy seedSingle arm study for comparison of computed tomography and oral poppy seed ingestion in fistula diagnosis. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pre and postsurgical gynecologic oncology patients who were suspected to have fistulas connecting gastrointestinal system and skin, bladder, vagina.
Key exclusion criteria (2 listed)
- None
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomography and poppy seedAlso: computed tomography, oral poppy seedcomparison of both interventions | Diagnostic test | Single arm study for comparison of computed tomography and oral poppy seed ingestion in fistula |
Primary outcome
sensitivity, specificity
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Results publication: PubMed 34791866Zizzo 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.
- Results publication: PubMed 11458060Schwaibold 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.
- Results publication: PubMed 19616793Melchior 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.
- Results publication: PubMed 16519642Wensky 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.
- Results publication: PubMed 18289575Kwon 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.
- Individual participant dataSharing planned: No
Related trials for Gynecologic Cancers
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
Active, not recruitingPhase 2
Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer
Ovarian Clear Cell Carcinoma, Gynecologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography and poppy seed in people with Gynecologic Cancers and Fistula, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity, specificity (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06793657, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.