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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nausea/Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clear Liquid Diet

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

Group Type EXPERIMENTAL

Clear Liquids

Intervention Type 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.

Abstats

Intervention Type DEVICE

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

Regular Solid Diet

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

Group Type EXPERIMENTAL

Regular Solid

Intervention Type DIETARY_SUPPLEMENT

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

Abstats

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Regular Solid

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

Intervention Type DIETARY_SUPPLEMENT

Abstats

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

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No