Randomized Controlled Trial of Fast-Track Rehabilitation After Elective Colorectal and Small Bowel Resection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- the Length of Hospital Stay
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ERP group
fast-track rehabilitation with early ambulation and diet after elective colorectal resection
Intervention: fast-track rehabilitation (Behavioral)
control group
traditional, conventional care group
Outcomes
Primary Outcomes
the Length of Hospital Stay
Time Frame: at discharge
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
Pain
Time Frame: at discharge
score measured by the Visual Analog Scale
Quality of Life
Time Frame: at discharge
measured by SF-36
Postoperative Complication During the First Admission
Time Frame: at discharge
Recovery
Time Frame: at discharge
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
Secondary Outcomes
- Readmission Rate(at postoperative day 30)
- Pain(at postoperative day 30)
- Quality of Life(at postoperative day 30)
- Postoperative Complication(at postoperative day 30)
Investigators
Sung-Bum Kang
Associate Professor Department of Surgery, Seoul National University Bundang Hospita
Seoul National University Hospital