PROSPECTIVE RANDOMIZED CONTROLLED TRIAL ON CLEAR FEEDS VERSUS LOW RESIDUE DIET AFTER SURGERY IN ELECTIVE COLORECTAL SURGERY PATIENTS.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Development of nausea and vomiting on postoperative day two
Study Overview
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 tolerability, incidence of nausea and/or vomiting, and postoperative length of hospitalization stay.
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 feeds is taken as 60%. This is a superiority trial: group one is the clear feeds group and patient tolerability in this group is taken to be 60%. Group two is the low residue diet group.
The primary hypothesis is that the incidence of postoperative ileus is not affected by the consistency of enteral diet given, and patients who are placed on low residue diet from postoperative day one do not have an increased risk of postoperative nausea and vomiting as compared to patients who are placed on clear feeds.
The primary endpoint measured is Patient tolerability, as evidenced by development of vomiting on postoperative day two.
Key Inclusion criteria are:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Low residue diet arm
Two arm randomized controlled trial. First arm is the Clear feeds on postoperative day one arm.
The second arm (interventional arm) is the Low Residue diet on postoperative day one arm.
Intervention: Low Residue diet arm. (Dietary Supplement)
Clear feeds arm
Standard of care is to start clear feeds on postoperative day one for elective colorectal surgery patients.
Intervention: Low Residue diet arm. (Dietary Supplement)
Outcomes
Primary Outcomes
Development of nausea and vomiting on postoperative day two
Time Frame: postoperative day two
Secondary Outcomes
No secondary outcomes reported
Investigators
Phillip Fleshner MD
Program Director, Colorectal Surgery Fellowship Shierley, Jesslyne, and Emmeline Widjaja Chair in Colorectal Surgery
Cedars-Sinai Medical Center