Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection

NCT ID: NCT00606944

Last Updated: 2012-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2011-09-30

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.

Conditions

Colorectal Tumor

Keywords

enhanced recovery program

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ERP group

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

Group Type: EXPERIMENTAL

fast-track rehabilitation

Intervention Type: BEHAVIORAL

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

control group

traditional, conventional care group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

fast-track rehabilitation

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sung-Bum Kang

Associate Professor Department of Surgery, Seoul National University Bundang Hospita

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung-Bum Kang, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Department of Surgery, Seoul National University Bundang Hospital

Seongnam, , South Korea

Sung-Bum Kang

Seongnam, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 23708720 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21160309 (View on PubMed)

Other Identifiers

B-0706-046-008

Identifier Type: -

Identifier Source: org_study_id

SNUBH-GS-CR1

Identifier Type: -

Identifier Source: secondary_id