Nausea/Vomiting
Conditions
Keywords
Tolerability diet after surgery
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.
Interventions
DIETARY_SUPPLEMENTClear 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.
DIETARY_SUPPLEMENTRegular Solid
Regular diet from postoperative day zero immediately upon return to floor and onwards
DEVICEAbstats
Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Antiemetic Usage | 30 days | If antiemetics were used in |
| Hospital Stay | 30 days | Length of postoperative stay |
| Post-operative Ileus | 30 days | Development of post-operative ileus |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clear Liquid Diet Clear liquids on postoperative day zero and intestinal rate measured by Abstats
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.
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery | 50 |
| Regular Solid Diet Regular diet from postoperative day zero and intestinal rate measured by Abstats
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Clear Liquid Diet | Total | Regular Solid Diet |
|---|---|---|---|
| Age, Continuous | 47.5 years STANDARD_DEVIATION 50 | 46.5 years STANDARD_DEVIATION 100 | 45.5 years STANDARD_DEVIATION 50 |
| Anastomosis Anastomosis formed | 35 Participants | 71 Participants | 36 Participants |
| Anastomosis No Anastomosis | 15 Participants | 29 Participants | 14 Participants |
| Body Mass Index | 23.6 kg/m^2 STANDARD_DEVIATION 4.3 | 23.1 kg/m^2 STANDARD_DEVIATION 4.1 | 22.7 kg/m^2 STANDARD_DEVIATION 4.9 |
| Diagnosis Cancer | 8 Participants | 14 Participants | 6 Participants |
| Diagnosis IBD | 39 Participants | 76 Participants | 37 Participants |
| Diagnosis Other | 3 Participants | 10 Participants | 7 Participants |
| Ostomy Use Colostomy | 2 Participants | 3 Participants | 1 Participants |
| Ostomy Use Ileostomy | 24 Participants | 46 Participants | 22 Participants |
| Ostomy Use No ostomy | 24 Participants | 51 Participants | 27 Participants |
| Prior abdominal surgery | 21 Participants | 41 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 50 Participants | 100 Participants | 50 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 28 Participants | 56 Participants | 28 Participants |
| Sex: Female, Male Male | 22 Participants | 44 Participants | 22 Participants |
| Site of surgery pelvis | 14 Participants | 31 Participants | 17 Participants |
| Site of surgery Right colon | 13 Participants | 25 Participants | 12 Participants |
| Site of surgery Small bowel | 9 Participants | 21 Participants | 12 Participants |
| Site of surgery Subtotal/left | 14 Participants | 23 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 11 / 50 | 11 / 50 |
Outcome results
Primary
Number of Participants Who Experienced Emesis on Post Operative Day 2
Patient tolerability, as evidenced by development of vomiting on postoperative day two.
Time frame: POD 2
Population: All participants undergoing surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Liquid Diet | Number of Participants Who Experienced Emesis on Post Operative Day 2 | 9 Participants |
| Regular Solid Diet | Number of Participants Who Experienced Emesis on Post Operative Day 2 | 9 Participants |
Secondary
Antiemetic Usage
If antiemetics were used in
Time frame: 30 days
Population: All participants undergoing surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Liquid Diet | Antiemetic Usage | 37 Participants |
| Regular Solid Diet | Antiemetic Usage | 30 Participants |
Secondary
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.
Time frame: POD 1 and POD 2 and Discharge
Population: All participants undergoing surgery.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Clear Liquid Diet | Bloating Score | POD 1 | 3 score on a scale |
| Clear Liquid Diet | Bloating Score | POD 2 | 2 score on a scale |
| Clear Liquid Diet | Bloating Score | POD 3 | 2 score on a scale |
| Regular Solid Diet | Bloating Score | POD 1 | 2 score on a scale |
| Regular Solid Diet | Bloating Score | POD 2 | 2 score on a scale |
| Regular Solid Diet | Bloating Score | POD 3 | 2 score on a scale |
Secondary
Hospital Stay
Length of postoperative stay
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clear Liquid Diet | Hospital Stay | 3 days | Standard Error 3.5 |
| Regular Solid Diet | Hospital Stay | 2.5 days | Standard Error 4 |
Secondary
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.
Time frame: POD 1 and POD 2 and Discharge
Population: All participants undergoing surgery.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Clear Liquid Diet | Nausea Score | POD 1 | 1 score on a scale |
| Clear Liquid Diet | Nausea Score | POD 2 | 1 score on a scale |
| Clear Liquid Diet | Nausea Score | Discharge | 1 score on a scale |
| Regular Solid Diet | Nausea Score | POD 2 | 1 score on a scale |
| Regular Solid Diet | Nausea Score | POD 1 | 1 score on a scale |
| Regular Solid Diet | Nausea Score | Discharge | 1 score on a scale |
Secondary
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.
Time frame: POD 0
Population: All participants undergoing surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Liquid Diet | Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0). | 46 Participants |
| Regular Solid Diet | Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0). | 34 Participants |
Secondary
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.
Time frame: POD 1 and POD 2 and Discharge
Population: All participants undergoing surgery
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Clear Liquid Diet | Pain Score | POD 1 | 4 score on a scale |
| Clear Liquid Diet | Pain Score | POD 2 | 3 score on a scale |
| Clear Liquid Diet | Pain Score | Discharge | 2 score on a scale |
| Regular Solid Diet | Pain Score | POD 1 | 4 score on a scale |
| Regular Solid Diet | Pain Score | POD 2 | 4 score on a scale |
| Regular Solid Diet | Pain Score | Discharge | 3 score on a scale |
Secondary
Post-operative Ileus
Development of post-operative ileus
Time frame: 30 days
Population: All participants undergoing surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Liquid Diet | Post-operative Ileus | 11 Participants |
| Regular Solid Diet | Post-operative Ileus | 11 Participants |