Clinical trial NCT00606944: Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection
Official title: Randomized Controlled Trial of Fast-Track Rehabilitation After Elective Colorectal and Small Bowel Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Tumor
Keywords: enhanced recovery program
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the Length of Hospital Stay
timeFrame: at discharge
measure: Pain
timeFrame: at discharge
measure: Quality of Life
timeFrame: at discharge
measure: Postoperative Complication During the First Admission
timeFrame: at discharge
measure: Recovery
timeFrame: at discharge
Secondary outcomes:
measure: Readmission Rate
timeFrame: at postoperative day 30
measure: Pain
timeFrame: at postoperative day 30
measure: Quality of Life
timeFrame: at postoperative day 30
measure: Postoperative Complication
timeFrame: at postoperative day 30
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Department of Surgery, Seoul National University Bundang Hospital
city: Seongnam
country: Korea, Republic of
facility: Sung-Bum Kang
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sung-Bum Kang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.