>The Purpose of This Study Was to Determine Whether Consuming a 100-mL Cup of Coffee is Effective in Preventing or Reducing Postoperative Ileus After Laparotomy of Benign Gynecological Patients
The Effects of Coffee Ingestion on Recovery of Bowel Function in Patients Undergoing Benign Gynecologic Operation : A Randomized Controlled Trial
1 other identifier
interventional
90
1 country
1
Brief Summary
Comparison of the effectiveness coffee (with or without caffeine) ingestion and water for reducing the duration of Postoperative ileus after Laparotomy of Benign Gynecological Patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 3, 2018
CompletedFirst Submitted
Initial submission to the registry
September 4, 2018
CompletedFirst Posted
Study publicly available on registry
September 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedOctober 30, 2019
July 1, 2018
1.1 years
September 4, 2018
October 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to flatus
measure time to first flatus after finished operation
ึ7 day
Secondary Outcomes (2)
time to toleration of a solid diet
7 day
time to defecation
7 day
Study Arms (3)
coffee group
EXPERIMENTALcaffeine coffee
decaffeinete coffee group
EXPERIMENTALdecaffeinete coffee group
water group
EXPERIMENTALInterventions
drank 3 cups of caffeinated coffee daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda. Coffee was prepared with a conventional coffee machine
drank 3 cups of decaffeinated coffee daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda. Coffee was prepared with a conventional coffee machine
drank 3 cups of still water daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda. Coffee was prepared with a conventional coffee machine
Eligibility Criteria
You may qualify if:
- Patients were asked to participate if they were scheduled to undergo laparotomy for a benign gynecologic condition
- Ever drink coffee before
- can speak or communication Thai language
You may not qualify if:
- hypersensitivity or allergy to caffeine/ coffee 2.ever intraabdominal sugery before 3. had an active intra-abdominal malignancy, bowel perforation, pre-existing bowel disease, or a history of abdominal or pelvic irradiation.
- pregnancy woman 5.thyroid disease 6 Inflammatory bowel disease 7.liver disease 8.cardiac arrhythmia 9.history of difficult to defecation ( feces only 2 times per week) 10.after operation need to stay in ICU more than 24 hr 11.need to put Ng tube after operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rajavithi Hospital
Phaya Thai, Bangkok, 10400, Thailand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2018
First Posted
September 6, 2018
Study Start
September 3, 2018
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
October 30, 2019
Record last verified: 2018-07