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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clear Liquid Diet | Experimental | Clear liquids on postoperative day zero and intestinal rate measured by Abstats |
|
| Regular Solid Diet | Experimental | Regular diet from postoperative day zero and intestinal rate measured by Abstats |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clear Liquids | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Emesis on Post Operative Day 2 | Patient tolerability, as evidenced by development of vomiting on postoperative day two. | POD 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | POD 0 |
| Antiemetic Usage |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria After randomization:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Fleshner, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25203881 | Background | 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. | |
| 25091837 | Background | Spiegel 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Emesis on Post Operative Day 2 | Patient tolerability, as evidenced by development of vomiting on postoperative day two. | All participants undergoing surgery | Posted | Count of Participants | Participants | POD 2 |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-operative Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Fleshner, MD | Cedars Sinai Medical Center | 310-289-9224 | pfleshner@aol.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2018 | Oct 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Regular Solid | Dietary Supplement | Regular diet from postoperative day zero immediately upon return to floor and onwards |
|
| Abstats | Device | Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery |
|
If antiemetics were used in |
| 30 days |
| Hospital Stay | Length of postoperative stay | 30 days |
| Post-operative Ileus | Development of post-operative ileus | 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. | 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. | 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. | POD 1 and POD 2 and Discharge |
| 37656683 | Derived | Yao 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Prior abdominal surgery | Count of Participants | Participants |
|
| Site of surgery | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Ostomy Use | Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery. 46 patient received and ileostomy and 3 patients received a colostomy. | Count of Participants | Participants |
|
| Anastomosis | Out of the 100 patients who were enrolled and had surgery only 71 patients had an anastomosis formed. That is why the total is 71 patient. 35 in clear liquid group and 36 in regular diet group had an anastomosis formed. | Count of Participants | Participants |
|
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 |
|
|
| 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. | All participants undergoing surgery | Posted | Count of Participants | Participants | POD 0 |
|
|
|
| Secondary | Antiemetic Usage | If antiemetics were used in | All participants undergoing surgery | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Hospital Stay | Length of postoperative stay | Posted | Mean | Standard Error | days | 30 days |
|
|
|
| Secondary | Post-operative Ileus | Development of post-operative ileus | All participants undergoing surgery | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 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. | All participants undergoing surgery | Posted | Mean | Full Range | score on a scale | POD 1 and POD 2 and Discharge |
|
|
|
| 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. | All participants undergoing surgery. | Posted | Mean | Full Range | score on a scale | POD 1 and POD 2 and Discharge |
|
|
|
| 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. | All participants undergoing surgery. | Posted | Mean | Full Range | score on a scale | POD 1 and POD 2 and Discharge |
|
|
|
| 0 |
| 50 |
| 11 |
| 50 |
| 0 |
| 50 |
| EG001 | 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 | 0 | 50 | 11 | 50 | 0 | 50 |
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| Discharge |
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| Discharge |
|
| POD 3 |
|