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

NCT ID: NCT01890499

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-09-30

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.

Conditions

Nausea/Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low Residue diet arm.

Intervention Type: DIETARY_SUPPLEMENT

Interventional arm is to provide low residue diet on postoperative day one.

Clear feeds arm

Standard of care is to start clear feeds on postoperative day one for elective colorectal surgery patients.

Group Type: ACTIVE_COMPARATOR

Low Residue diet arm.

Intervention Type: DIETARY_SUPPLEMENT

Interventional arm is to provide low residue diet on postoperative day one.

Interventions

Low Residue diet arm.

Interventional arm is to provide low residue diet on postoperative day one.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Phillip Fleshner MD

Program Director, Colorectal Surgery Fellowship Shierley, Jesslyne, and Emmeline Widjaja Chair in Colorectal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

philip R Fleshner, M.D

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

Pro00029966

Identifier Type: -

Identifier Source: org_study_id