Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection
Randomized Controlled Trial of Fast-Track Rehabilitation After Elective Colorectal and Small Bowel Resection
2 other identifiers
interventional
200
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2007
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 22, 2008
CompletedFirst Posted
Study publicly available on registry
February 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
August 21, 2012
CompletedAugust 21, 2012
July 1, 2012
2.3 years
January 22, 2008
July 19, 2012
July 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
the Length of Hospital Stay
discharge criteria 1. Tolerance of consecutive 3 soft bland diet 2. Unassisted ambulation 3. No necessity of analgesics 4. Afebrile without major complication 5. Willing to discharge
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 1. Tolerance of consecutive 3 soft bland diet 2. Unassisted ambulation 3. No necessity of analgesics 4. Afebrile without major complication
at discharge
Secondary Outcomes (4)
Readmission Rate
at postoperative day 30
Pain
at postoperative day 30
Quality of Life
at postoperative day 30
Postoperative Complication
at postoperative day 30
Study Arms (2)
ERP group
EXPERIMENTALfast-track rehabilitation with early ambulation and diet after elective colorectal resection
control group
NO INTERVENTIONtraditional, conventional care group
Interventions
fast-track rehabilitation with early ambulation and diet after elective colorectal resection
Eligibility Criteria
You may qualify if:
- Patients between 20 - 80 years old
- Class ASA (American Society of Anesthesiology) I, II or III, +/- E
- Patient willing to participate in the study
- Patient who understands and accepts to sign the informed consent form
- Patient who will undergo elective colorectal resection using laparoscopic surgery defined as follows: patients who received one of the following surgery:right hemicolectomy, left hemicolectomy, anterior resection with primary anastomosis, and low anterior resection with loop ileostomy for fecal diversion
You may not qualify if:
- Class ASA IV or V patient
- Documented problem of gastro-intestinal motility
- Combined resection of other organ than the colorectum
- Presence of obstructive colorectal cancer associated with dilatation of the proximal gastrointestinal tract
- Presence of residual peritoneal carcinosis at the end of surgery
- Previous history of intra-abdominal surgery except simple appendectomy, cholecystectomy, or hysterectomy for uterine myoma
- Creation of colo-rectal, colo-anal or ileo-anal anastomosis without loop ileostomy
- Any per-surgery discovery which requires the use of a gastric drainage procedure following surgery
- Any post-surgery change in patient condition which requires naso-gastric tube holding after surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Surgery, Seoul National University Bundang Hospital
Seongnam, 463-707, South Korea
Sung-Bum Kang
Seongnam, 463-707, South Korea
Related Publications (2)
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.
PMID: 23708720DERIVEDLee 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.
PMID: 21160309DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sung-Bum Kang
- Organization
- Seoul National University Bundang Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Sung-Bum Kang, M.D., Ph.D
Seoul National University Bundang Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Department of Surgery, Seoul National University Bundang Hospita
Study Record Dates
First Submitted
January 22, 2008
First Posted
February 5, 2008
Study Start
June 1, 2007
Primary Completion
October 1, 2009
Study Completion
September 1, 2011
Last Updated
August 21, 2012
Results First Posted
August 21, 2012
Record last verified: 2012-07