Nausea/VomitingNCT03260426
Trial of Low Residue Diet Versus Clear Liquids Following Elective Colorectal Surgery
A study testing Clear Liquids, Regular Solid and Abstats in people with Nausea/Vomiting, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea/Vomiting
- What is being tested?
- Clear Liquids, Regular Solid and Abstats
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: 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.
Read the 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.
- Conditions
- Nausea/Vomiting
- Being tested
- Clear Liquids, Regular Solid, Abstats
- Keywords
- Tolerability diet after surgery
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear LiquidsDietary 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.
Regular SolidDietary supplement
Regular diet from postoperative day zero immediately upon return to floor and onwards
AbstatsDevice
Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
| Study group | Role | What they receive |
|---|---|---|
| Clear Liquid Diet | Experimental | Clear liquids on postoperative day zero and intestinal rate measured by Abstats Receives: Dietary Supplement: Clear Liquids; Device: Abstats |
| Regular Solid Diet | Experimental | Regular diet from postoperative day zero and intestinal rate measured by Abstats Receives: Dietary Supplement: Regular Solid; Device: Abstats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Emesis on Post Operative Day 2
Patient tolerability, as evidenced by development of vomiting on postoperative day two.
Measured: 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).
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.
Measured: POD 0
Antiemetic Usage
If antiemetics were used in
Measured: 30 days
Hospital Stay
Length of postoperative stay
Measured: 30 days
Post-operative Ileus
Development of post-operative ileus
Measured: 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.
Measured: 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.
Measured: 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.
Measured: POD 1 and POD 2 and Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start16 Aug 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nausea/VomitingStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Fleshner MD, Cedars-Sinai Medical Center
- Investigators
- Phillip Fleshner, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260426
- Sponsor's protocol ID
- Pro00048403
- Status last verified
- Jan 2020
- First submitted
- 18 Aug 2017
- Last updated
- 31 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 25203881Spiegel 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.
PubMed 25091837Yao 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.
PubMed 37656683
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Investigating Commencement of Low Residue Diet Versus Clear Liquids on Postoperative Zero Following Elective Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03260426
- Acronym / sponsor ID
- Pro00048403
- Conditions
- Nausea/Vomiting
- Keywords
- Tolerability diet after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Posted 31 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear Liquid Diet | Experimental | Dietary Supplement: Clear Liquids, Device: AbstatsClear liquids on postoperative day zero and intestinal rate measured by Abstats |
| Regular Solid Diet | Experimental | Dietary Supplement: Regular Solid, Device: AbstatsRegular diet from postoperative day zero and intestinal rate measured by Abstats |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clear LiquidsClear 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. | Dietary supplement | Clear Liquid Diet |
| Regular SolidRegular diet from postoperative day zero immediately upon return to floor and onwards | Dietary supplement | Regular Solid Diet |
| AbstatsIntestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery | Device | Clear Liquid Diet, Regular Solid Diet |
Primary outcome
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.
7 secondary outcomes
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
Antiemetic Usage
Time frame: 30 days
Hospital Stay
Time frame: 30 days
Post-operative Ileus
Time frame: 30 days
Pain Score
Time frame: POD 1 and POD 2 and Discharge
Nausea Score
Time frame: POD 1 and POD 2 and Discharge
Bloating Score
Time frame: POD 1 and POD 2 and Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25203881Lau 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.
- Background: PubMed 25091837Spiegel 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.
- Derived from this study: PubMed 37656683Yao 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.
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip Fleshner, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Liquids, Regular Solid and Abstats in people with Nausea/Vomiting, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Emesis on Post Operative Day 2 (time frame: POD 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03260426, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.