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

Prospective Randomized Controlled Trial Investigating Commencement of Low Residue Diet Versus Clear Liquids on Postoperative Zero Following Elective Colorectal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Nausea/Vomiting
• Intervention / Treatment: Dietary supplement: Clear Liquids; Device: Abstats; Dietary supplement: Regular Solid

Detailed Description

Offering patients, a low residue diet on the first postoperative day (POD1) after colorectal surgery is safe and improves surgical outcomes and postoperative hospital stay. Early use of low solid is superior to clear liquid diet after elective colorectal surgery.

The purpose of this study is to prospectively evaluate whether providing a patient a solid diet from postoperative day zero is superior to clear liquids. The primary endpoint measured will be patient tolerability, as evidenced by absence of vomiting. The secondary endpoints measured will be duration of supplemental intravenous hydration needed, length of hospital stay and postoperative complications, and intestinal rate measured by Abstats.

Abstats™ consists of a disposable plastic device embedded with a microphone that adheres to the abdominal wall and connects to a computer measuring acoustic event rates. The monitor will be placed on the patient's abdomen 30 minutes prior to surgery in the preoperative holding area to obtain baseline intestinal rate. The monitor will be removed prior to surgery and replaced by the surgical team in the operating room and maintained until postoperative day 3. Daily intestinal rate will be calculated as mean and median acoustic events per minute. The raw data will be analyzed by an investigator blinded to the clinical data. Intestinal rates of patients offered immediate solid feeds will be compared with those offered clear feeds. In addition, patients not tolerating or consuming early solid meal will be compared with those who do to identify whether Abstat™ can be an early predictor of diet intolerance in patients undergoing colorectal surgery.

Patients will be assigned into one of two groups:

Group I - 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.

Group II - Regular diet from postoperative day zero immediately upon return to floor and onwards.

Three questionnaires assessing quality of life are to be completed by the patient, during his/her hospital stay. On postoperative day one, a self-administered questionnaire is to be completed by the patient. Please see appendix A for the questionnaire details. The same questionnaire is administered on postoperative day two and again on the last day of hospitalization.

• Study Type: Interventional
• Enrollment (Actual): 100
• 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 robotic/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 including hiatus hernia, gastroesophageal reflux disease, peptic ulcer disease.
5. Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.
6. Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).
7. Pregnant patients.
8. Bedbound or moribund patients.
9. Pre-existing history of clinical depression.
10. Epidural analgesia.
11. Surgical procedures completed after 4pm
12. Patients taking narcotics prior to elective colorectal surgery

Exclusion Criteria After randomization:

1. Postoperative diagnosis of intra-abdominal sepsis, including anastomotic leaks.
2. Postoperative complications requiring early reoperation within the same hospital stay.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clear Liquid Diet; Clear liquids on postoperative day zero and intestinal rate measured by Abstats	Dietary supplement: Clear Liquids; 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.; Device: Abstats; Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
Experimental: Regular Solid Diet; Regular diet from postoperative day zero and intestinal rate measured by Abstats	Device: Abstats; Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery; Dietary supplement: Regular Solid; Regular diet from postoperative day zero immediately upon return to floor and onwards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0).	Tolerability of regular diet will be determined by the patients ability to eat more than 50% of a solid meal on post operative day zero.	POD 0
Antiemetic Usage	If antiemetics were used in	30 days
Hospital Stay	Length of postoperative stay	30 days
Post-operative Ileus	Development of post-operative ileus	30 days
Pain Score	Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome. Pain score evaluated POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.	POD 1 and POD 2 and Discharge
Nausea Score	Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome. Nausea Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.	POD 1 and POD 2 and Discharge
Bloating Score	Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome. Bloating Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.	POD 1 and POD 2 and Discharge

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Tolerability diet after surgery
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: Pro00048403

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes