Colorectal Tumor
Conditions
Keywords
enhanced recovery program
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.
Interventions
BEHAVIORALfast-track rehabilitation
fast-track rehabilitation with early ambulation and diet after elective colorectal resection
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery | 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 |
| the Length of Hospital Stay | 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 | at discharge | score measured by the Visual Analog Scale |
| Quality of Life | at discharge | measured by SF-36 |
| Postoperative Complication During the First Admission | at discharge | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | at postoperative day 30 | score measured by the Visual Analog Scale |
| Quality of Life | at postoperative day 30 | measured by SF-36 |
| Postoperative Complication | at postoperative day 30 | — |
| Readmission Rate | at postoperative day 30 | — |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group traditional, conventional care group | 100 |
| ERP Group Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation | 98 |
| Total | 198 |
Baseline characteristics
| Characteristic | ERP Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 49 Participants | 42 Participants | 91 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 58 Participants | 107 Participants |
| Age Continuous | 61.5 years STANDARD_DEVIATION 10.9 | 61.1 years STANDARD_DEVIATION 11 | 61.3 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment Korea, Republic of | 98 participants | 100 participants | 198 participants |
| Sex: Female, Male Female | 36 Participants | 42 Participants | 78 Participants |
| Sex: Female, Male Male | 62 Participants | 58 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 100 | 28 / 98 |
| serious Total, serious adverse events | 0 / 100 | 1 / 98 |
Outcome results
Primary
Pain
score measured by the Visual Analog Scale
Time frame: at discharge
Primary
Postoperative Complication During the First Admission
Time frame: at discharge
Primary
Quality of Life
measured by SF-36
Time frame: at discharge
Primary
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
Primary
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
Population: 1 mortality case was excluded for analysis in the ERP group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | the Length of Hospital Stay | 8 day |
| ERP Group | the Length of Hospital Stay | 7 day |
Secondary
Pain
score measured by the Visual Analog Scale
Time frame: at postoperative day 30
Secondary
Postoperative Complication
Time frame: at postoperative day 30
Secondary
Quality of Life
measured by SF-36
Time frame: at postoperative day 30
Secondary
Readmission Rate
Time frame: at postoperative day 30