Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection

Colorectal Tumor Clinical Trial

Official title:

Randomized Controlled Trial of Fast-Track Rehabilitation After Elective Colorectal and Small Bowel Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606944
• Other study ID #: B-0706-046-008
• Secondary ID: SNUBH-GS-CR1
• Status: Completed
• Phase: N/A
• First received: January 22, 2008
• Last updated: July 19, 2012
• Start date: June 2007
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Tumor

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Sung-Bum Kang	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at discharge	No
Primary	Pain	score measured by the Visual Analog Scale	at discharge	No
Primary	Quality of Life	measured by SF-36	at discharge	No
Primary	Postoperative Complication During the First Admission		at discharge	Yes
Primary	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	at discharge	No
Secondary	Readmission Rate		at postoperative day 30	Yes
Secondary	Pain	score measured by the Visual Analog Scale	at postoperative day 30	No
Secondary	Quality of Life	measured by SF-36	at postoperative day 30	No
Secondary	Postoperative Complication		at postoperative day 30	Yes