- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01990482
Influence of Coffee Intake on Postoperative Bowel Function After Comprehensive Staging Surgery for Gynecological Malignancies: A Randomized Controlled Trial.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tepecik
-
Izmir, Tepecik, Turkey, 35600
- Tepecik Education Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: coffee
|
|
Placebo Comparator: water group
water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time to first flatus
Time Frame: within the first 30 days after surgery
|
hours from end of operation to first flatus pass time
|
within the first 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time to tolerance diet
Time Frame: within the first 30 days after surgery
|
time to end of the surgery until the first solid diet intake without vomiting
|
within the first 30 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- gungorduk15
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