Nausea/Vomiting Clinical Trial
Official title:
Prospective Randomized Controlled Trial Investigating Commencement of Low Residue Diet Versus Clear Liquids on Postoperative Zero Following Elective Colorectal Surgery
Prospective randomized controlled trial investigating commencement of low residue diet versus clear liquids on postoperative zero following elective colorectal surgery, with regards to patient tolerability, incidence of nausea and/or vomiting, and postoperative length of hospitalization stay.
Offering patients, a low residue diet on the first postoperative day (POD1) after colorectal
surgery is safe and improves surgical outcomes and postoperative hospital stay. Early use of
low solid is superior to clear liquid diet after elective colorectal surgery.
The purpose of this study is to prospectively evaluate whether providing a patient a solid
diet from postoperative day zero is superior to clear liquids. The primary endpoint measured
will be patient tolerability, as evidenced by absence of vomiting. The secondary endpoints
measured will be duration of supplemental intravenous hydration needed, length of hospital
stay and postoperative complications, and intestinal rate measured by Abstats.
Abstats™ consists of a disposable plastic device embedded with a microphone that adheres to
the abdominal wall and connects to a computer measuring acoustic event rates. The monitor
will be placed on the patient's abdomen 30 minutes prior to surgery in the preoperative
holding area to obtain baseline intestinal rate. The monitor will be removed prior to surgery
and replaced by the surgical team in the operating room and maintained until postoperative
day 3. Daily intestinal rate will be calculated as mean and median acoustic events per
minute. The raw data will be analyzed by an investigator blinded to the clinical data.
Intestinal rates of patients offered immediate solid feeds will be compared with those
offered clear feeds. In addition, patients not tolerating or consuming early solid meal will
be compared with those who do to identify whether Abstat™ can be an early predictor of diet
intolerance in patients undergoing colorectal surgery.
Patients will be assigned into one of two groups:
Group I - Clear liquids on postoperative day zero immediately upon return to the floor and
subsequent days' advancement of enteral diet to regular diet is as per discretion of the
attending physician.
Group II - Regular diet from postoperative day zero immediately upon return to floor and
onwards.
Three questionnaires assessing quality of life are to be completed by the patient, during
his/her hospital stay. On postoperative day one, a self-administered questionnaire is to be
completed by the patient. Please see appendix A for the questionnaire details. The same
questionnaire is administered on postoperative day two and again on the last day of
hospitalization.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01890499 -
Prospective Controlled Trial On Clear Feeds Versus Low Residue Diet After Surgery In Elective Colorectal Surgery Patients
|
N/A | |
| Terminated |
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Phase 4 |