Status:
COMPLETED
Prospective Controlled Trial On Clear Feeds Versus Low Residue Diet After Surgery In Elective Colorectal Surgery Patients
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Nausea/Vomiting
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective randomized controlled trial investigating commencement of low residue diet versus clear feeds on postoperative day one following elective colorectal surgery, with regards to patient tolera...
Detailed Description
Based on current literature, the incidence of postoperative nausea and vomiting varies widely and can reach up to 40% in abdominal surgery patients. Thus, patient tolerability to postoperative enteral...
Eligibility Criteria
Inclusion
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- Males or females, \>18 years of age inclusive at the time of study screening;
- American Society of Anesthesiologists (ASA) Class I-III;
- Colorectal surgery (open and/or laparoscopic);
- Elective Surgery.
Exclusion
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures.
- Children \<18 years of age.
- Pre-operative clinical diagnosis of intestinal obstruction.
- Pre-existing known upper gastrointestinal disorders.
- Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.
- Open upper abdominal surgical incisions.
- Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).
- Pregnant patients.
- Bedbound or moribund patients.
- Pre-existing history of clinical depression.
- Epidural analgesia.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01890499
Start Date
November 1 2012
End Date
September 1 2013
Last Update
February 4 2015
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048