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| ID | Type | Description | Link |
|---|---|---|---|
| SNUBH-GS-CR1 |
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The purpose of this study is to address the question of whether or not oral alimentation and ambulation exercise should be begun early in patients following laparoscopic colorectal surgery compared to the classical diet and ambulation which depends on reappearance of functional intestinal transit. Early oral alimentation following laparoscopic colorectal surgery may decrease hospital stay and facilitate earlier discharge with comparable postoperative morbidity.
Traditionally, patients who received laparoscopic colorectal surgery were treated with the classical protocol including the use of a naso-gastric tube and starvation for several postoperative days till the recovery of bowel movement, or bed resting at immediate postoperative period followed by ward ambulation at the postoperative day 1 or 2. Restarting the oral alimentation is based on gas or feces reappearance after surgery and usually this is possible at several days following surgery. However, prolonged starvation might be uncomfortable for the patient as well as increasing his postoperative hospital stay. Recently, several studies reported the efficacy of early rehabilitation protocols after intestinal surgery, showing that early oral alimentation could reduce the length of hospital stay and cost of hospitalization without significant increase of postoperative complications, compared to traditional management.
This prospective, randomized study was designed to evaluate the effectiveness of a postoperative care pathway using rehabilitation with early ambulation and diet for patients undergoing elective laparoscopic colorectal resection compared with the traditional postoperative care.
In order to conduct this study, patients having a laparoscopic colon resection will be randomly attributed to enhanced recovery program group or control group, which is divided based on the postoperative management protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERP group | Experimental | fast-track rehabilitation with early ambulation and diet after elective colorectal resection |
|
| control group | No Intervention | traditional, conventional care group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fast-track rehabilitation | Behavioral | fast-track rehabilitation with early ambulation and diet after elective colorectal resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Length of Hospital Stay | discharge criteria
| at discharge |
| Pain | score measured by the Visual Analog Scale | at discharge |
| Quality of Life | measured by SF-36 | at discharge |
| Postoperative Complication During the First Admission | at discharge | |
| Recovery | recovery criteria must include all of the following
| at discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission Rate | at postoperative day 30 | |
| Pain | score measured by the Visual Analog Scale | at postoperative day 30 |
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Inclusion Criteria:
• Patients between 20 - 80 years old
Exclusion Criteria:
• Class ASA IV or V patient
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Bum Kang, M.D., Ph.D | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Seoul National University Bundang Hospital | Seongnam | 463-707 | South Korea | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23708720 | Derived | Lee SM, Kang SB, Jang JH, Park JS, Hong S, Lee TG, Ahn S. Early rehabilitation versus conventional care after laparoscopic rectal surgery: a prospective, randomized, controlled trial. Surg Endosc. 2013 Oct;27(10):3902-9. doi: 10.1007/s00464-013-3006-4. Epub 2013 May 25. | |
| 21160309 | Derived | Lee TG, Kang SB, Kim DW, Hong S, Heo SC, Park KJ. Comparison of early mobilization and diet rehabilitation program with conventional care after laparoscopic colon surgery: a prospective randomized controlled trial. Dis Colon Rectum. 2011 Jan;54(1):21-8. doi: 10.1007/DCR.0b013e3181fcdb3e. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | traditional, conventional care group |
| FG001 | ERP Group | Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | traditional, conventional care group |
| BG001 | ERP Group | Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | the Length of Hospital Stay | discharge criteria
| 1 mortality case was excluded for analysis in the ERP group | Posted | Median | Inter-Quartile Range | day | at discharge |
|
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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 | Control Group | traditional, conventional care group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Gastrointestinal disorders | Systematic Assessment | 1 patient in ERP group who underwent low anterior resection for rectal cancer died due to aspiration pneumonia at postoperative 3day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Systematic Assessment | defined by patient's symptom and X-ray |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sung-Bum Kang | Seoul National University Bundang Hospital | +82-31-787-7093 | kangsb@snubh.org |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Quality of Life |
measured by SF-36 |
| at postoperative day 30 |
| Postoperative Complication | at postoperative day 30 |
| Sung-Bum Kang |
| Seongnam |
| 463-707 |
| South Korea |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Pain | score measured by the Visual Analog Scale | Not Posted | at discharge |
| Primary | Quality of Life | measured by SF-36 | Not Posted | at discharge |
| Primary | Postoperative Complication During the First Admission | Not Posted | at discharge |
| Primary | Recovery | recovery criteria must include all of the following
| Not Posted | at discharge |
| Secondary | Readmission Rate | Not Posted | at postoperative day 30 |
| Secondary | Pain | score measured by the Visual Analog Scale | Not Posted | at postoperative day 30 |
| Secondary | Quality of Life | measured by SF-36 | Not Posted | at postoperative day 30 |
| Secondary | Postoperative Complication | Not Posted | at postoperative day 30 |
| 0 |
| 100 |
| 16 |
| 100 |
| EG001 | ERP Group | Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation | 1 | 98 | 28 | 98 |
|
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Chylous ascites | Gastrointestinal disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |