Effect of Coffee Consumption on Intestinal Motility
- Conditions
- Gastrointestinal Motility
- Interventions
- Dietary Supplement: coffee
- Registration Number
- NCT03191877
- Lead Sponsor
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Brief Summary
Randomized controlled trial in Obstetrics and Gynecology department (MULTI-CENTRIC).To measure the effect of coffee consumption on intestinal motility after caesarean section for the patient who fulfills the criteria. Then they will be randomized to 3 groups. The primary outcome and secondary outcome will be measured.
- Detailed Description
Randomized controlled trial. Participants who fulfill the inclusion criteria (elective caesarian section, singleton pregnancy, term, viable fetus), and exclusion criteria (medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance ) Then they will be randomized to 3 groups. Group 1, will start to drink coffee 6 hours postoperative for maximum 3 doses (100ml), 8 hours apart, diet will start after 1st audible bowel sound.
Group 2, will drink water 6 hours postoperative. Diet will start after 1st audible bowel sound.
Group 3 is the control group and they will be (NOTHING PER ORAL) for 24 hours on intravenous fluid (3 LITRES/24 HOURS). Diet will start after 1st audible bowel sound.
Primary outcome: passage of stool. Secondary outcome: passage of flatus, audible intestinal sound time, feeding time, pain scale by Visual Analogue Scale (VAS), amount, and type of analgesia needed, breastfeeding time, mobilization and hospital stay.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 600
- elective caesarian section, singleton pregnancy, term, viable fetus
- medical disorders, known intestinal diseases, past history of intestinal surgery, intraoperative diagnosis of extensive adhesion, intraoperative complications "e.g., intestinal injury and ureteric injury intraoperative complication that can lengthen the operation time, postoperative complications like anesthesia complication and electrolytes imbalance )
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COFFEE coffee they will start to drink coffee 6 hours postoperative for maximum 3 doses (100ml), 8 hours apart, diet will start after 1st audible bowel sound. oral fluid coffee they will drink plain fluid (water) 6 hours postoperative. Diet will start after 1st audible bowel sound. Women in this group will not receive either coffee.
- Primary Outcome Measures
Name Time Method passage of stool. 72 hours passage of stool within 72 hours. (time to be recorded by 24-hour clock from finishing of surgery)
- Secondary Outcome Measures
Name Time Method Type of analgesia needed. 72 hours Type of analgesia needed. (paracetamol, nonsteroidal anti-inflammatory drugs or pethidine ).
The amount of analgesia . 72 hours ( recording of dose and frequency in time are mandatory ).
Audible intestinal sound time. 72 hours Audible first intestinal sound time.(time to be recorded by the 24-hour clock from finishing of surgery).
Pain scale by VAS (Visual Analogue Scale ). 72 hours Pain scale by using Visual Analogue Scale(VAS). it is measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
No pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).The first Breastfeeding time. 72 hours (time to be recorded by 24-hour clock from finishing of surgery)
Passage of flatus. . The amount of analgesia. The first Breastfeeding time. The initiation of Mobilization. Hospital length stay. 72 hours (time to be recorded by the 24-hour clock from finishing of surgery).
Feeding time 72 hours Feeding time (StARTING OF REGULAR DIET ).(time to be recorded by the 24-hour clock from finishing of surgery).
Hospital length stay. 72 hours ( in Days )
The initiation of Mobilization. 72 hours (time to be recorded by 24-hour clock from finishing of surgery)
Trial Locations
- Locations (1)
AFHSR
🇸🇦Khamis Mushait, Abha, Saudi Arabia