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Trial registered on ANZCTR


Registration number
ACTRN12618001772235
Ethics application status
Approved
Date submitted
23/10/2018
Date registered
29/10/2018
Date last updated
1/05/2019
Date data sharing statement initially provided
29/10/2018
Date results information initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of coffee consumption on bowel function after cesarean section
Scientific title
The effect of coffee consumption on bowel function after cesarean section
Secondary ID [1] 296397 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cesarean section 310144 0
bowel function 310145 0
Condition category
Condition code
Reproductive Health and Childbirth 308894 308894 0 0
Normal pregnancy
Oral and Gastrointestinal 308895 308895 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this randomized controlled trial is to assess whether coffee consumption accelerates the recovery of bowel function after cesarean section. Patients will be randomly assigned to study. Group 1 will be served as coffee group whereas group 2 with no treatment. The patients in study arm will drink 100 milliliter sugar and milk free-caffeinated coffee on the 2nd, 6th and 18th hour after surgery by nursery or doctor. The time to first bowel movements, first flatus and first defecation will be asked to patients three times daily by an evaluator blinded to the study allocation and results will be recorded.
Intervention code [1] 312738 0
Treatment: Other
Comparator / control treatment
Control group is the patients undergoing cesarean with spinal anesthesia. The patients in control group will not drink coffee postoperatively.
Control group
Active

Outcomes
Primary outcome [1] 307876 0
The time to first flatus will be asked to patiens three times daily by an evaluator blinded to the study allocation and results will be recorded.
Timepoint [1] 307876 0
postoperatively 24h
Secondary outcome [1] 353198 0
Secondary outcome is time to first bowel movements.
The time to first bowel movements will be asked to patiens three times daily by an evaluator blinded to the study allocation and results will be recorded.
Timepoint [1] 353198 0
48h after cesarean section
Secondary outcome [2] 353272 0
first defecation
Timepoint [2] 353272 0
The time to first defecation will be asked to patiens three times daily by an evaluator blinded to the study allocation up to 3 days and results will be recorded.

Eligibility
Key inclusion criteria
Women age between 18-35 years, undergoing elective cesarean section with spinal anesthesia will be included the study.
Minimum age
18 Years
Maximum age
35 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The women were excluded if emergency cesarean, cesarean with general anesthesia, previous pelvic or abdominal surgery, chronic constipation, any known thyroid disease, irritable bowel syndrome and any known hypersensitivity or allergy to caffeine. The patients were also excluded if the surgery lasted more than 90 minutes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data analysis was performed by SPSS 16.0 . Normalitiy of variables was examined using by the Kolmogorov- Smirnov test. The Chi-squared and Fisher’s tests were used to compare categorical variables, Student’st-test was employed to compare normally distributed continuous variables, and the Mann– Whitney U-test was used to compare variables that were not normally distributed. P-value ssmaller than 0.05 were considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20952 0
Turkey
State/province [1] 20952 0
Mugla

Funding & Sponsors
Funding source category [1] 301005 0
Self funded/Unfunded
Name [1] 301005 0
Melike Korkmaz Toker.
Address [1] 301005 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country [1] 301005 0
Turkey
Primary sponsor type
Individual
Name
Melike Korkmaz Toker
Address
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country
Turkey
Secondary sponsor category [1] 300601 0
None
Name [1] 300601 0
Address [1] 300601 0
Country [1] 300601 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301761 0
Mugla Sitki Kocman University Clinical Trials Ethical Committee.
Ethics committee address [1] 301761 0
Mugla Sitki Kocman University Clinical Trials Ethical Committee.
Mugla Sitki Kocman University Medical Faculty Dean Office 48001 MUGLA/TURKEY
Ethics committee country [1] 301761 0
Turkey
Date submitted for ethics approval [1] 301761 0
13/07/2017
Approval date [1] 301761 0
09/08/2017
Ethics approval number [1] 301761 0
2017,13.4

Summary
Brief summary
Coffee is a popular drink in worldwide and improves general well-being. And it also positively affects central nervous system,cardiovascular system and reproductive system . It’s known that coffee stimulates colonic motor activity in healthy volunteers. There is a limited scientific evidence regarding its effects on gastrointestinal function, Two reports have shown that coffee consumption after open and laparoscopic colectomy is both safe and associated with reduced time of first bowel action. However , there is only one study investigated the effect on gastrointestinal function in patients after cesarean section according to a systematic review of literature. Thus, the primary outcome of this randomized controlled trial will be to assess mean time to first flatus, secondary outcome will be to assess mean time to first bowel movements and first defecation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88014 0
Dr Melike Korkmaz Toker
Address 88014 0
Kotekli Mahallesi Mugla Sitki Koçman Universitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country 88014 0
Turkey
Phone 88014 0
+905054747098
Fax 88014 0
Email 88014 0
melkorkmaz@gmail.com
Contact person for public queries
Name 88015 0
Dr Melike Korkmaz Toker
Address 88015 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country 88015 0
Turkey
Phone 88015 0
+905054747098
Fax 88015 0
Email 88015 0
melkorkmaz@gmail.com
Contact person for scientific queries
Name 88016 0
Dr Sezen Bozkurt Koseoglu
Address 88016 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Kadin Hastaliklari ve Dogum Klinigi Mugla, 48001, Türkiye
Country 88016 0
Turkey
Phone 88016 0
+905052596606
Fax 88016 0
Email 88016 0
drsezenkoseoglu@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary