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Trial record 43 of 7078 for:    zero

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03260426
Recruitment Status : Completed
First Posted : August 24, 2017
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Phillip Fleshner MD, 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.

Condition or disease Intervention/treatment Phase
Nausea/Vomiting Dietary Supplement: Clear Liquids Dietary Supplement: Regular Solid Device: Abstats Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial Investigating Commencement of Low Residue Diet Versus Clear Liquids on Postoperative Zero Following Elective Colorectal Surgery
Actual Study Start Date : August 16, 2017
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


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
Dietary Supplement: Regular Solid
Regular diet from postoperative day zero immediately upon return to floor and onwards

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




Primary Outcome Measures :
  1. Number of Participants Who Experienced Emesis on Post Operative Day 2 [ Time Frame: POD 2 ]
    Patient tolerability, as evidenced by development of vomiting on postoperative day two.


Secondary Outcome Measures :
  1. Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0). [ Time Frame: 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.

  2. Antiemetic Usage [ Time Frame: 30 days ]
    If antiemetics were used in

  3. Hospital Stay [ Time Frame: 30 days ]
    Length of postoperative stay

  4. Post-operative Ileus [ Time Frame: 30 days ]
    Development of post-operative ileus

  5. Pain Score [ Time Frame: 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.


  6. Nausea Score [ Time Frame: 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.


  7. Bloating Score [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260426


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Phillip Fleshner, MD Cedars-Sinai Medical Center
  Study Documents (Full-Text)

Documents provided by Phillip Fleshner MD, Cedars-Sinai Medical Center:
Publications:
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Responsible Party: Phillip Fleshner MD, Clinical Professor of Surgery, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03260426    
Other Study ID Numbers: Pro00048403
First Posted: August 24, 2017    Key Record Dates
Results First Posted: January 31, 2020
Last Update Posted: January 31, 2020
Last Verified: January 2020

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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
Keywords provided by Phillip Fleshner MD, Cedars-Sinai Medical Center:
Tolerability diet after surgery
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms