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

PROSPECTIVE RANDOMIZED CONTROLLED TRIAL ON CLEAR FEEDS VERSUS LOW RESIDUE DIET AFTER SURGERY IN ELECTIVE COLORECTAL SURGERY PATIENTS.

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.

Study Overview

• Status: Completed
• Conditions: Nausea/Vomiting
• Intervention / Treatment: Dietary supplement: Low Residue diet arm.

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Low Residue diet arm.; Interventional arm is to provide low residue diet on postoperative day one.
Active Comparator: Clear feeds arm; Standard of care is to start clear feeds on postoperative day one for elective colorectal surgery patients.	Dietary supplement: Low Residue diet arm.; Interventional arm is to provide low residue diet on postoperative day one.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Development of nausea and vomiting on postoperative day two	postoperative day two

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: philip R Fleshner, M.D, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: June 28, 2013
• First Posted (Estimate): July 1, 2013

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: tolerability; diet after operation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: Pro00029966