Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sung-Bum Kang, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00606944
First received: January 22, 2008
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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 Intervention
Colorectal Tumor
Behavioral: fast-track rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Fast-Track Rehabilitation After Elective Colorectal and Small Bowel Resection

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • the Length of Hospital Stay [ Time Frame: at discharge ] [ Designated as safety issue: No ]

    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

  • Pain [ Time Frame: at discharge ] [ Designated as safety issue: No ]
    score measured by the Visual Analog Scale

  • Quality of Life [ Time Frame: at discharge ] [ Designated as safety issue: No ]
    measured by SF-36

  • Postoperative Complication During the First Admission [ Time Frame: at discharge ] [ Designated as safety issue: Yes ]
  • Recovery [ Time Frame: at discharge ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Readmission Rate [ Time Frame: at postoperative day 30 ] [ Designated as safety issue: Yes ]
  • Pain [ Time Frame: at postoperative day 30 ] [ Designated as safety issue: No ]
    score measured by the Visual Analog Scale

  • Quality of Life [ Time Frame: at postoperative day 30 ] [ Designated as safety issue: No ]
    measured by SF-36

  • Postoperative Complication [ Time Frame: at postoperative day 30 ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: June 2007
Study Completion Date: September 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606944

Locations
Korea, Republic of
Department of Surgery, Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
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
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sung-Bum Kang, Associate Professor Department of Surgery, Seoul National University Bundang Hospita, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00606944     History of Changes
Other Study ID Numbers: B-0706-046-008, SNUBH-GS-CR1
Study First Received: January 22, 2008
Results First Received: July 19, 2012
Last Updated: July 19, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
enhanced recovery program

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 29, 2014