Prospective Controlled Trial On Clear Feeds Versus Low Residue Diet After Surgery In Elective Colorectal Surgery Patients

Not Applicable

Completed

• Conditions: Nausea/Vomiting
• Interventions: Dietary Supplement: Low Residue diet arm.

• Registration Number: NCT01890499
• Lead Sponsor: Cedars-Sinai Medical Center

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:

1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;

2. Males or females, \>18 years of age inclusive at the time of study screening;

3. American Society of Anesthesiologists (ASA) Class I-III;

4. Colorectal surgery (open and/or laparoscopic);

5. Elective Surgery.

Key Exclusion criteria are:

1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures.

2. Children \<18 years of age.

3. Pre-operative clinical diagnosis of intestinal obstruction.

4. Pre-existing known upper gastrointestinal disorders.

5. Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.

6. Open upper abdominal surgical incisions.

7. Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).

8. Pregnant patients.

9. Bedbound or moribund patients.

10. Pre-existing history of clinical depression.

11. Epidural analgesia.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-01
• Primary Completion: 2013-08
• Study Completion: 2013-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
2. Males or females, >18 years of age inclusive at the time of study screening;
3. American Society of Anesthesiologists (ASA) Class I-III;
4. Colorectal surgery (open and/or laparoscopic);
5. Elective Surgery.

Exclusion Criteria

1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures.
2. Children <18 years of age.
3. Pre-operative clinical diagnosis of intestinal obstruction.
4. Pre-existing known upper gastrointestinal disorders.
5. Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.
6. Open upper abdominal surgical incisions.
7. Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).
8. Pregnant patients.
9. Bedbound or moribund patients.
10. Pre-existing history of clinical depression.
11. Epidural analgesia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clear feeds arm	Low Residue diet arm.	Standard of care is to start clear feeds on postoperative day one for elective colorectal surgery patients.
Low residue diet arm	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.

Primary Outcome Measures

Name	Time	Method
Development of nausea and vomiting on postoperative day two	postoperative day two

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States