Nausea/VomitingNCT01890499
Prospective Controlled Trial On Clear Feeds Versus Low Residue Diet After Surgery In Elective Colorectal Surgery Patients
A study testing Low Residue diet arm. 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 feeds on postoperative day one 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?
- Low Residue diet arm.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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.
- Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.
- Open upper abdominal surgical incisions.
Show all 11Show fewer
- Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).
- Pregnant patients.
- Bedbound or moribund patients.
- Pre-existing history of clinical depression.
- Epidural analgesia.
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 ON CLEAR FEEDS VERSUS LOW RESIDUE DIET AFTER SURGERY IN ELECTIVE COLORECTAL SURGERY PATIENTS.
Prospective randomized controlled trial investigating commencement of low residue diet versus clear feeds on postoperative day one 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
Based on current literature, the incidence of postoperative nausea and vomiting varies widely and can reach up to 40% in abdominal surgery patients. Thus, patient tolerability to postoperative enteral feeds is taken as 60%. This is a superiority trial: group one is the clear feeds group and patient tolerability in this group is taken to be 60%. Group two is the low residue diet group.
The primary hypothesis is that the incidence of postoperative ileus is not affected by the consistency of enteral diet given, and patients who are placed on low residue diet from postoperative day one do not have an increased risk of postoperative nausea and vomiting as compared to patients who are placed on clear feeds.
The primary endpoint measured is Patient tolerability, as evidenced by development of vomiting on postoperative day two.
Key Inclusion criteria are:
- 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 laparoscopic);
- Elective Surgery.
Key Exclusion criteria are:
- 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.
- Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.
- Open upper abdominal surgical incisions.
- Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).
- Pregnant patients.
- Bedbound or moribund patients.
- Pre-existing history of clinical depression.
- Epidural analgesia.
- Conditions
- Nausea/Vomiting
- Being tested
- Low Residue diet arm.
- Keywords
- tolerability, diet after operation
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Residue diet arm.Dietary supplement
Interventional arm is to provide low residue diet on postoperative day one.
| Study group | Role | What they receive |
|---|---|---|
| Low residue diet arm | Experimental | Two arm randomized controlled trial. First arm is the Clear feeds on postoperative day one arm.
The second arm (interventional arm) is the Low Residue diet on postoperative day one arm. Receives: Dietary Supplement: Low Residue diet arm. |
| Clear feeds arm | Active comparator | Standard of care is to start clear feeds on postoperative day one for elective colorectal surgery patients. Receives: Dietary Supplement: Low Residue diet arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of nausea and vomiting on postoperative day two
Measured: postoperative day two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 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
- philip R Fleshner, M.D, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890499
- Sponsor's protocol ID
- Pro00029966
- Status last verified
- Feb 2015
- First submitted
- 27 Jun 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE RANDOMIZED CONTROLLED TRIAL ON CLEAR FEEDS VERSUS LOW RESIDUE DIET AFTER SURGERY IN ELECTIVE COLORECTAL SURGERY PATIENTS.
- ClinicalTrials.gov ID
- NCT01890499
- Acronym / sponsor ID
- Pro00029966
- Conditions
- Nausea/Vomiting
- Keywords
- tolerability, diet after operation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Not posted in the source record
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 feeds on postoperative day one following elective colorectal surgery, with regards to patient tolerability, incidence of nausea and/or vomiting, and postoperative length of hospitalization stay.
Detailed description
Based on current literature, the incidence of postoperative nausea and vomiting varies widely and can reach up to 40% in abdominal surgery patients. Thus, patient tolerability to postoperative enteral feeds is taken as 60%. This is a superiority trial: group one is the clear feeds group and patient tolerability in this group is taken to be 60%. Group two is the low residue diet group.
The primary hypothesis is that the incidence of postoperative ileus is not affected by the consistency of enteral diet given, and patients who are placed on low residue diet from postoperative day one do not have an increased risk of postoperative nausea and vomiting as compared to patients who are placed on clear feeds.
The primary endpoint measured is Patient tolerability, as evidenced by development of vomiting on postoperative day two.
Key Inclusion criteria are:
- 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 laparoscopic);
- Elective Surgery.
Key Exclusion criteria are:
- 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.
- Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.
- Open upper abdominal surgical incisions.
- Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).
- Pregnant patients.
- Bedbound or moribund patients.
- Pre-existing history of clinical depression.
- Epidural analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low residue diet arm | Experimental | Dietary Supplement: Low Residue diet arm.Two arm randomized controlled trial. First arm is the Clear feeds on postoperative day one arm. The second arm (interventional arm) is the Low Residue diet on postoperative day one arm. |
| Clear feeds arm | Active comparator | Dietary Supplement: Low Residue diet arm.Standard of care is to start clear feeds on postoperative day one for elective colorectal surgery patients. |
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 laparoscopic);
- Elective Surgery.
Key exclusion criteria (11 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.
- 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 |
|---|---|---|
| Low Residue diet arm.Interventional arm is to provide low residue diet on postoperative day one. | Dietary supplement | Clear feeds arm, Low residue diet arm |
Primary outcome
Development of nausea and vomiting on postoperative day two
Time frame: postoperative day two
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
Related trials for Nausea/Vomiting
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and 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.
philip R Fleshner, M.D 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 Low Residue diet arm. 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 11 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 4 Feb 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Development of nausea and vomiting on postoperative day two (time frame: postoperative day two). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2015.