search
Back to results

Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection

Primary Purpose

Colorectal Tumor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fast-track rehabilitation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Tumor focused on measuring enhanced recovery program

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • • 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

Sites / Locations

  • Department of Surgery, Seoul National University Bundang Hospital
  • Sung-Bum Kang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ERP group

control group

Arm Description

fast-track rehabilitation with early ambulation and diet after elective colorectal resection

traditional, conventional care group

Outcomes

Primary Outcome Measures

the Length of Hospital Stay
discharge criteria Tolerance of consecutive 3 soft bland diet Unassisted ambulation No necessity of analgesics Afebrile without major complication Willing to discharge
Pain
score measured by the Visual Analog Scale
Quality of Life
measured by SF-36
Postoperative Complication During the First Admission
Recovery
recovery criteria must include all of the following Tolerance of consecutive 3 soft bland diet Unassisted ambulation No necessity of analgesics Afebrile without major complication

Secondary Outcome Measures

Readmission Rate
Pain
score measured by the Visual Analog Scale
Quality of Life
measured by SF-36
Postoperative Complication

Full Information

First Posted
January 22, 2008
Last Updated
July 19, 2012
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00606944
Brief Title
Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection
Official Title
Randomized Controlled Trial of Fast-Track Rehabilitation After Elective Colorectal and Small Bowel Resection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Tumor
Keywords
enhanced recovery program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERP group
Arm Type
Experimental
Arm Description
fast-track rehabilitation with early ambulation and diet after elective colorectal resection
Arm Title
control group
Arm Type
No Intervention
Arm Description
traditional, conventional care group
Intervention Type
Behavioral
Intervention Name(s)
fast-track rehabilitation
Intervention Description
fast-track rehabilitation with early ambulation and diet after elective colorectal resection
Primary Outcome Measure Information:
Title
the Length of Hospital Stay
Description
discharge criteria Tolerance of consecutive 3 soft bland diet Unassisted ambulation No necessity of analgesics Afebrile without major complication Willing to discharge
Time Frame
at discharge
Title
Pain
Description
score measured by the Visual Analog Scale
Time Frame
at discharge
Title
Quality of Life
Description
measured by SF-36
Time Frame
at discharge
Title
Postoperative Complication During the First Admission
Time Frame
at discharge
Title
Recovery
Description
recovery criteria must include all of the following Tolerance of consecutive 3 soft bland diet Unassisted ambulation No necessity of analgesics Afebrile without major complication
Time Frame
at discharge
Secondary Outcome Measure Information:
Title
Readmission Rate
Time Frame
at postoperative day 30
Title
Pain
Description
score measured by the Visual Analog Scale
Time Frame
at postoperative day 30
Title
Quality of Life
Description
measured by SF-36
Time Frame
at postoperative day 30
Title
Postoperative Complication
Time Frame
at postoperative day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 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 Exclusion Criteria: • 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Bum Kang, M.D., Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Sung-Bum Kang
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23708720
Citation
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.
Results Reference
derived
PubMed Identifier
21160309
Citation
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.
Results Reference
derived

Learn more about this trial

Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection

We'll reach out to this number within 24 hrs