Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00606944
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Arms: 2
• Duration (Months): 51
• Patients Per Site: 100
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Tumor	Behavioral: fast-track rehabilitation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Fast-Track Rehabilitation After Elective Colorectal and Small Bowel Resection
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ERP group fast-track rehabilitation with early ambulation and diet after elective colorectal resection	Behavioral: fast-track rehabilitation; fast-track rehabilitation with early ambulation and diet after elective colorectal resection
No Intervention: control group traditional, conventional care group

Outcome Measures

Primary Outcome Measures

1. the Length of Hospital Stay [at discharge]

   discharge criteria Tolerance of consecutive 3 soft bland diet Unassisted ambulation No necessity of analgesics Afebrile without major complication Willing to discharge

2. Pain [at discharge]

   score measured by the Visual Analog Scale

3. Quality of Life [at discharge]

   measured by SF-36

4. Postoperative Complication During the First Admission [at discharge]

5. Recovery [at discharge]

   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

1. Readmission Rate [at postoperative day 30]

2. Pain [at postoperative day 30]

   score measured by the Visual Analog Scale

3. Quality of Life [at postoperative day 30]

   measured by SF-36

4. Postoperative Complication [at postoperative day 30]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Seoul National University Bundang Hospital	Seongnam		Korea, Republic of	463-707
2	Sung-Bum Kang	Seongnam		Korea, Republic of	463-707

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Sung-Bum Kang, M.D., Ph.D, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sung-Bum Kang, Associate Professor Department of Surgery, Seoul National University Bundang Hospita, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT00606944
• Other Study ID Numbers: B-0706-046-008; SNUBH-GS-CR1
• First Posted: Feb 5, 2008
• Last Update Posted: Aug 21, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Sung-Bum Kang, Associate Professor Department of Surgery, Seoul National University Bundang Hospita, Seoul National University Hospital: enhanced recovery program
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

Participant Flow

Arm/Group Title	Control Group	ERP Group
Arm/Group Description	traditional, conventional care group	Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
Period Title: Overall Study
STARTED	98	100
COMPLETED	98	100
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control Group	ERP Group	Total
Arm/Group Description	traditional, conventional care group	Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation	Total of all reporting groups
Overall Participants	100	98	198
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	58 58%	49 50%	107 54%
>=65 years	42 42%	49 50%	91 46%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.1 (11.0)	61.5 (10.9)	61.3 (10.9)
Sex: Female, Male (Count of Participants)
Female	42 42%	36 36.7%	78 39.4%
Male	58 58%	62 63.3%	120 60.6%
Region of Enrollment (participants) [Number]
Korea, Republic of	100 100%	98 100%	198 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

1 mortality case was excluded for analysis in the ERP group

Arm/Group Title	Control Group	ERP Group
Arm/Group Description	traditional, conventional care group	Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
Measure Participants	100	97
Median (Inter-Quartile Range) [day]	8	7

2. Primary Outcome

Title	Pain
Description	score measured by the Visual Analog Scale
Time Frame	at discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

Title	Quality of Life
Description	measured by SF-36
Time Frame	at discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Primary Outcome

Title	Postoperative Complication During the First Admission
Time Frame	at discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Readmission Rate
Time Frame	at postoperative day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Pain
Description	score measured by the Visual Analog Scale
Time Frame	at postoperative day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Quality of Life
Description	measured by SF-36
Time Frame	at postoperative day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Postoperative Complication
Time Frame	at postoperative day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Control Group		ERP Group
Arm/Group Description	traditional, conventional care group		Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
All Cause Mortality
	Control Group		ERP Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		ERP Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		1/98 (1%)
Gastrointestinal disorders
Death	0/100 (0%)	0	1/98 (1%)	1
Other (Not Including Serious) Adverse Events
	Control Group		ERP Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/100 (16%)		28/98 (28.6%)
Gastrointestinal disorders
Ileus	7/100 (7%)	7	17/98 (17.3%)	17
Chylous ascites	5/100 (5%)	5	6/98 (6.1%)	6
Renal and urinary disorders
Urinary retention	5/100 (5%)	5	9/98 (9.2%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.