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

20 Years
80 Years
Not Enrolling
Colorectal Tumor

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

the Length of Hospital Stay

Outcome Description:

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

Outcome Time Frame:

at discharge

Safety Issue:


Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Bundang Hospital


South Korea: Institutional Review Board

Study ID:




Start Date:

June 2007

Completion Date:

September 2011

Related Keywords:

  • Colorectal Tumor
  • enhanced recovery program
  • Colorectal Neoplasms