Trial of Low Residue Diet Versus Clear Liquids Following Elective Colorectal Surgery

NCT03260426 | Completed Results DMC FDA Device

• 1 other identifier: Pro00048403
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective randomized controlled trial investigating commencement of low residue diet versus clear liquids on postoperative zero 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 surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Emesis on Post Operative Day 2

  Patient tolerability, as evidenced by development of vomiting on postoperative day two.

  POD 2

Secondary Outcomes (7)

• Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0).

  POD 0

• Antiemetic Usage

  30 days

• Hospital Stay

  30 days

• Post-operative Ileus

  30 days

• Pain Score

  POD 1 and POD 2 and Discharge

Study Arms (2)

Clear Liquid Diet

EXPERIMENTAL

Clear liquids on postoperative day zero and intestinal rate measured by Abstats

Dietary Supplement: Clear Liquids; Device: Abstats

Regular Solid Diet

EXPERIMENTAL

Regular diet from postoperative day zero and intestinal rate measured by Abstats

Dietary Supplement: Regular Solid; Device: Abstats

Interventions

Clear Liquids DIETARY_SUPPLEMENT

Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.

Clear Liquid Diet

Regular Solid DIETARY_SUPPLEMENT

Regular diet from postoperative day zero immediately upon return to floor and onwards

Regular Solid Diet

Abstats DEVICE

Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery

Clear Liquid Diet; Regular Solid Diet

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 robotic/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 including hiatus hernia, gastroesophageal reflux disease, peptic ulcer disease.
• Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.
• 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.
• Surgical procedures completed after 4pm
• Patients taking narcotics prior to elective colorectal surgery
• Postoperative diagnosis of intra-abdominal sepsis, including anastomotic leaks.
• Postoperative complications requiring early reoperation within the same hospital stay.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (3)

• Lau C, Phillips E, Bresee C, Fleshner P. Early use of low residue diet is superior to clear liquid diet after elective colorectal surgery: a randomized controlled trial. Ann Surg. 2014 Oct;260(4):641-7; discussion 647-9. doi: 10.1097/SLA.0000000000000929.

  PMID: 25203881 BACKGROUND

• Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5.

  PMID: 25091837 BACKGROUND

• Yao LY, Gough AE, Zaghiyan KN, Fleshner PR. Prospective Randomized Trial of Immediate Postoperative Use of Regular Diet Versus Clear Liquid Diet in Major Colorectal Surgery. Dis Colon Rectum. 2023 Dec 1;66(12):1547-1554. doi: 10.1097/DCR.0000000000002737. Epub 2023 Aug 31.

  PMID: 37656683 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Phillip Fleshner, MD
• Organization: Cedars Sinai Medical Center

pfleshner@aol.com

310-289-9224

Study Officials

• Phillip Fleshner, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Surgery

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 24, 2017
• Study Start: August 16, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: January 31, 2020
• Results First Posted: January 31, 2020

Record last verified: 2020-01

Locations

US (1)