IluesNCT01990482
Influence of Coffee Intake on Postoperative Bowel Function After Comprehensive Staging Surgery for Gynecological Malignancies: A Randomized Controlled Trial.
A study testing caffe and Water in people with Ilues, run by Erzincan Military Hospital at 1 site in Turkey (Türkiye).
Trial summary
A delay in the return of normal bowel function with the passage of flatus and feces is one of the most important factors affecting early recovery and discharge in patients undergoing open complete staging surgery for gynecological malignancies. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ilues
- What is being tested?
- caffe and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Female patients preparing for complete surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancerwere assessed for eligibility. Exclusion Criteria: Exclusion criteria for the study
- included thyroid diseases,
- inflammatory bowel disease,
- complaints of chronic constipation (defined as two or fewer bowel movements per week),
- a history of prior abdominal bowel surgery, abdominal radiation, neoadjuvant chemotherapy,
- need for intensive care more that 24 hpostoperatively,
- nasogastric tube drainage beyond the first postoperative morning,
- bowel anastomosis and upper abdominalmultivisceral surgical approaches in relation to the debulking surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Education Research Hospital
Izmir, Tepecik, 35600
About this study
A delay in the return of normal bowel function with the passage of flatus and feces is one of the most important factors affecting early recovery and discharge in patients undergoing open complete staging surgery for gynecological malignancies. A prolonged hospital stay increases the risk of hospital-acquired infections, deep vein thrombosis, pulmonary compromise and total hospital costs.
The aim of this study was to assess the effectiveness of coffee intake on postoperative bowel function in patients undergoing abdominal complete staging surgery for gynecological malignancies.
- Conditions
- Ilues
- Being tested
- caffe, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeDietary supplement
WaterDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| coffee | Experimental | coffee Receives: Dietary Supplement: caffe; Dietary Supplement: Water |
| water group | Placebo comparator | water Receives: Dietary Supplement: caffe; Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first flatus
hours from end of operation to first flatus pass time
Measured: within the first 30 days after surgery
Secondary outcomes (1)
time to tolerance diet
time to end of the surgery until the first solid diet intake without vomiting
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IluesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal GUNGORDUK, Erzincan Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990482
- Sponsor's protocol ID
- gungorduk15
- Status last verified
- Nov 2013
- First submitted
- 10 Nov 2013
- Last updated
- 22 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Coffee Intake on Postoperative Bowel Function After Comprehensive Staging Surgery for Gynecological Malignancies: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01990482
- Acronym / sponsor ID
- gungorduk15
- Conditions
- Ilues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Erzincan Military HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Nov 2013 (estimated)
- 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.
A delay in the return of normal bowel function with the passage of flatus and feces is one of the most important factors affecting early recovery and discharge in patients undergoing open complete staging surgery for gynecological malignancies. A prolonged hospital stay increases the risk of hospital-acquired infections, deep vein thrombosis, pulmonary compromise and total hospital costs.
The aim of this study was to assess the effectiveness of coffee intake on postoperative bowel function in patients undergoing abdominal complete staging surgery for gynecological malignancies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coffee | Experimental | Dietary Supplement: caffe, Dietary Supplement: Watercoffee |
| water group | Placebo comparator | Dietary Supplement: caffe, Dietary Supplement: Waterwater |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients preparing for complete surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancerwere assessed for eligibility. Exclusion Criteria: Exclusion criteria for the study
- included thyroid diseases,
- inflammatory bowel disease,
- complaints of chronic constipation (defined as two or fewer bowel movements per week),
- a history of prior abdominal bowel surgery, abdominal radiation, neoadjuvant chemotherapy,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| caffe | Dietary supplement | coffee, water group |
| Water | Dietary supplement | coffee, water group |
Primary outcome
time to first flatus
Time frame: within the first 30 days after surgery
hours from end of operation to first flatus pass time
1 secondary outcome
time to tolerance diet
Time frame: within the first 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
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 caffe and Water in people with Ilues, run by Erzincan Military Hospital 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 8 inclusion and 0 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: finished, as of the sponsor's last update on 22 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to first flatus (time frame: within the first 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2016.