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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.
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:
Key Exclusion criteria are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low residue diet arm | Experimental | 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. |
|
| Clear feeds arm | Active Comparator | Standard of care is to start clear feeds on postoperative day one for elective colorectal surgery patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Residue diet arm. | Dietary Supplement | Interventional arm is to provide low residue diet on postoperative day one. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of nausea and vomiting on postoperative day two | postoperative day two |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| philip R Fleshner, M.D | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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