Colorectal TumorNCT00606944
Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection
A study testing fast-track rehabilitation in people with Colorectal Tumor, run by Seoul National University Hospital at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colorectal Tumor
- What is being tested?
- fast-track rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jun 2007to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
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- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Department of Surgery, Seoul National University Bundang Hospital
Seongnam, 463-707
Sung-Bum Kang
Seongnam, 463-707
About this study
Official title: Randomized Controlled Trial of Fast-Track Rehabilitation After Elective Colorectal and Small Bowel Resection
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.
Read the 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.
- Conditions
- Colorectal Tumor
- Being tested
- fast-track rehabilitation
- Keywords
- enhanced recovery program
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast-track rehabilitationBehavioural
fast-track rehabilitation with early ambulation and diet after elective colorectal resection
| Study group | Role | What they receive |
|---|---|---|
| ERP group | Experimental | fast-track rehabilitation with early ambulation and diet after elective colorectal resection Receives: Behavioral: fast-track rehabilitation |
| control group | No intervention | traditional, conventional care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Length of Hospital Stay
discharge criteria
- Tolerance of consecutive 3 soft bland diet
- Unassisted ambulation
- No necessity of analgesics
- Afebrile without major complication
- Willing to discharge
Measured: at discharge
Pain
score measured by the Visual Analog Scale
Measured: at discharge
Quality of Life
measured by SF-36
Measured: at discharge
Postoperative Complication During the First Admission
Measured: at discharge
Recovery
recovery criteria must include all of the following
- Tolerance of consecutive 3 soft bland diet
- Unassisted ambulation
- No necessity of analgesics
- Afebrile without major complication
Measured: at discharge
Secondary outcomes (4)
Readmission Rate
Measured: at postoperative day 30
Pain
score measured by the Visual Analog Scale
Measured: at postoperative day 30
Quality of Life
measured by SF-36
Measured: at postoperative day 30
Postoperative Complication
Measured: at postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJun 2007
- Primary completionOct 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal TumorStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Bum Kang, Seoul National University Hospital
- Investigators
- Sung-Bum Kang, M.D., Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606944
- Sponsor's protocol ID
- B-0706-046-008
- Other IDs
- SNUBH-GS-CR1
- Status last verified
- Jul 2012
- First submitted
- 22 Jan 2008
- Last updated
- 21 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23708720Lee 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.
PubMed 21160309
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Fast-Track Rehabilitation After Elective Colorectal and Small Bowel Resection
- ClinicalTrials.gov ID
- NCT00606944
- Acronym / sponsor ID
- B-0706-046-008
- Conditions
- Colorectal Tumor
- Keywords
- enhanced recovery program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Posted 21 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERP group | Experimental | Behavioral: fast-track rehabilitationfast-track rehabilitation with early ambulation and diet after elective colorectal resection |
| control group | No intervention | –traditional, conventional care group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients between 20 - 80 years old
Key exclusion criteria (9 listed)
- • Class ASA IV or V patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fast-track rehabilitationfast-track rehabilitation with early ambulation and diet after elective colorectal resection | Behavioural | ERP group |
Primary outcome
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
4 secondary outcomes
Readmission Rate
Time frame: at postoperative day 30
Pain
Time frame: at postoperative day 30
Quality of Life
Time frame: at postoperative day 30
Postoperative Complication
Time frame: at postoperative day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23708720Lee 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.
- Derived from this study: PubMed 21160309Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Bum Kang, M.D., Ph.D principal investigator
Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fast-track rehabilitation in people with Colorectal Tumor, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Length of Hospital Stay (time frame: at discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00606944, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.