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

NCT01890499 | Completed DMC

• 1 other identifier: Pro00029966
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea/Vomiting

Keywords

tolerability; diet after operation

Outcome Measures

Primary Outcomes (1)

• Development of nausea and vomiting on postoperative day two

  postoperative day two

Study Arms (2)

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.

Dietary Supplement: Low Residue diet arm.

Clear feeds arm

ACTIVE COMPARATOR

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

Dietary Supplement: Low Residue diet arm.

Interventions

Low Residue diet arm. DIETARY_SUPPLEMENT

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

Clear feeds arm; Low residue diet arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• philip R Fleshner, M.D

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Colorectal Surgery Fellowship Shierley, Jesslyne, and Emmeline Widjaja Chair in Colorectal Surgery

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 1, 2013
• Study Start: November 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

US (1)