Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection

Seoul National University Hospital200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Colorectal Tumor

Interventions

fast-track rehabilitationBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Department of Surgery, Seoul National University Bundang Hospital

Seongnam, South Korea

Sung-Bum Kang

Seongnam, South Korea

Outcomes

Primary Outcomes

the Length of Hospital Stay

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

Time frame: at discharge

Pain

score measured by the Visual Analog Scale

Time frame: at discharge

Quality of Life

measured by SF-36

Time frame: at discharge

Postoperative Complication During the First Admission

Time frame: at discharge

Recovery

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

Time frame: at discharge

Secondary Outcomes

Readmission Rate

Time frame: at postoperative day 30

Pain

score measured by the Visual Analog Scale

Time frame: at postoperative day 30

Quality of Life

measured by SF-36

Time frame: at postoperative day 30

Postoperative Complication

Time frame: at postoperative day 30

Data from ClinicalTrials.gov

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