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

Not Applicable

Completed

• Conditions: Nausea/Vomiting
• Interventions: Dietary Supplement: Clear Liquids; Dietary Supplement: Regular Solid; Device: Abstats

• Registration Number: NCT03260426
• Lead Sponsor: Cedars-Sinai Medical Center

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.

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 Timeline

• Study Start: 2017-08-16
• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-24
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Results First Submitted: 2019-10-30
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-17
• Last Update Submitted: 2020-01-17
• Results First Posted: 2020-01-31
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clear Liquid Diet	Abstats	Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Clear Liquid Diet	Clear Liquids	Clear liquids on postoperative day zero and intestinal rate measured by Abstats
Regular Solid Diet	Regular Solid	Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid Diet	Abstats	Regular diet from postoperative day zero and intestinal rate measured by Abstats

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Emesis on Post Operative Day 2	POD 2	Patient tolerability, as evidenced by development of vomiting on postoperative day two.

Secondary Outcome Measures

Name	Time	Method
Nausea Score	POD 1 and POD 2 and Discharge	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.
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	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.
Hospital Stay	30 days	Length of postoperative stay
Antiemetic Usage	30 days	If antiemetics were used in
Post-operative Ileus	30 days	Development of post-operative ileus
Bloating Score	POD 1 and POD 2 and Discharge	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.
Pain Score	POD 1 and POD 2 and Discharge	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.

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States