Gastrointestinal Disorders, Functional Clinical Trial
Official title:
Early Versus Late Feeding After Cesarean Delivery: A Randomized Controlled Trial
After institutional review approval, pregnant women that are scheduled for elective cesarean
delivery will be approached for participation in the study. The study informed consent will
be obtained. The study's time frame inclusive will be from 2013 till 2016.
Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus
remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced
as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the
investigators' institution.
Primary outcome will be time to pass flatus. Secondary outcomes will include hospital length
of stay, postoperative nausea, vomiting and patient satisfaction. Randomization will be
performed using a computer generated random list of numbers assigning patients to the 2
groups of the study. This list of random number assignments will be kept secure in an opaque
envelope until the end of the study. Patients in the Early group will be started on regular
diet within 6 hrs of surgery, whereas the routine group patients will be kept strict NPO
12hrs, and clear liquid diet will be started after 12hrs. Diet will be advanced as
tolerated, i.e. if clears were tolerated or flatus or bowel movement occurred, patients will
be started on solid foods. If diet not tolerated, a full liquid diet will be given instead.
Consequently if patient tolerated full liquid diet, a regular diet will be then initiated.
Patients will be discharged home only if they tolerate solid food with absence of emesis,
have flatus or bowel movement. Time Zero is defined as time of skin incision.
After institutional review approval, pregnant women that are scheduled for elective cesarean delivery will be approached by Principal investigator or any of the co-investigators for participation in the study during the the preoperative visit which coincides with the same day of scheduled cesarean in a private patient room. . Prospective subjects will be presenting for their preoperative appointment (same day of scheduled cesarean delivery) in labor and delivery and will be asked to participate in the study. The study will be explained as in the consent form and if agreed patients will elect either to or not to participate in the study after all risks and benefits are explained. Data to be collected will consist of time in minutes of passing flatus, time in minutes of having a bowel movement, hospital length of stay, postoperative nausea, vomiting and presence of ileus (unable to tolerate diet, abdominal distention, no bowel movement nor flatus, abdominal x-ray demonstrating air/fluid levels in bowel). Patients will be contacted once to twice a day for assessment of data points mentioned above. If elected to participate consents will be obtained. Randomization will be done at time of consents. The study's time frame inclusive will be from 2013 till 2016. ;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02327377 -
Web-based Management of Pediatric Functional Abdominal Pain
|
N/A |