Colorectal CancerPhase 3NCT00758186
Randomized Trial of Colonic Stents as a Bridge to Surgery
A Phase 3 study testing Emergency endoscopic colonic stenting and Emergency surgery in people with Colorectal Cancer and Intestinal Obstruction, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The objective of this randomized controlled trial was to evaluate the role colonic self-expanding metal stent (SEMS) placement as a bridge to surgery in patients with acute malignant left-sided colonic obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Intestinal Obstruction
- What is being tested?
- Emergency endoscopic colonic stenting and Emergency surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2004to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute intestinal obstruction secondary to left-sided colonic cancer
Who cannot join
- Distal rectal cancers
- Patients with signs of peritonitis suggestive of bowel perforation
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Department of Colorectal Surgery, Singapore General Hospital
Singapore, 169608
About this study
Official title: Endoscopic Stenting and Elective Surgery Versus Emergency Surgery for Left-sided Malignant Colonic Obstruction: A Prospective Randomized Trial.
The objective of this randomized controlled trial was to evaluate the role colonic self-expanding metal stent (SEMS) placement as a bridge to surgery in patients with acute malignant left-sided colonic obstruction. The study was designed to test the hypothesis that SEMS placement could be effectively and safely used in this group of patients to relieve colonic obstruction thereby allowing safe recovery and medical stabilization before proceeding to elective surgery
- Conditions
- Colorectal Cancer, Intestinal Obstruction
- Being tested
- Emergency endoscopic colonic stenting, Emergency surgery
- Keywords
- Colorectal cancer, Endoscopic stent, Intestinal obstruction, Laparoscopy
- Medical subject headings
- Colorectal Neoplasms, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency endoscopic colonic stentingProcedure or surgery
Colonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction. Patients who had successful stenting were discharged and re-admitted for elective surgery. Patients in whom stenting was unsuccessful underwent emergency surgery. The choice of surgery performed was up to the individual consultant colorectal surgeon.
Emergency surgeryProcedure or surgery
Patients underwent emergency surgery for acute left-sided malignant colonic obstruction. The choice of surgery performed was up to the individual consultant colorectal surgeon. Surgery included primary resection with or without defunctioning stoma and palliative diverting stoma only.
| Study group | Role | What they receive |
|---|---|---|
| Colonic-stenting | Experimental | Colonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction. Receives: Procedure: Emergency endoscopic colonic stenting |
| Emergency surgery | Active comparator | Emergency surgery: Patients underwent emergency surgery for acute left-sided malignant colonic obstruction. Receives: Procedure: Emergency surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was postoperative complication rates.
Measured: 30 days
Secondary outcomes (1)
Secondary outcomes evaluated included type of surgery performed, bowel preservation, presence of a stoma, postoperative bowel function, length of hospital stay, and hospitalization costs.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startOct 2004
- Primary completionFeb 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Singapore General 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kok-Sun Ho, FRCSEd, Principal investigator, Department of Colorectal Surgery, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758186
- Sponsor's protocol ID
- Colonic-Stenting-001
- Status last verified
- Apr 2018
- First submitted
- 23 Sep 2008
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lim JF, Tang CL, Seow-Choen F, Heah SM. Prospective, randomized trial comparing intraoperative colonic irrigation with manual decompression only for obstructed left-sided colorectal cancer. Dis Colon Rectum. 2005 Feb;48(2):205-9. doi: 10.1007/s10350-004-0803-9.
PubMed 15714241Saida Y, Sumiyama Y, Nagao J, Uramatsu M. Long-term prognosis of preoperative "bridge to surgery" expandable metallic stent insertion for obstructive colorectal cancer: comparison with emergency operation. Dis Colon Rectum. 2003 Oct;46(10 Suppl):S44-9. doi: 10.1097/01.DCR.0000087483.63718.A2.
PubMed 14530657Martinez-Santos C, Lobato RF, Fradejas JM, Pinto I, Ortega-Deballon P, Moreno-Azcoita M. Self-expandable stent before elective surgery vs. emergency surgery for the treatment of malignant colorectal obstructions: comparison of primary anastomosis and morbidity rates. Dis Colon Rectum. 2002 Mar;45(3):401-6. doi: 10.1007/s10350-004-6190-4.
PubMed 12068202Khot UP, Lang AW, Murali K, Parker MC. Systematic review of the efficacy and safety of colorectal stents. Br J Surg. 2002 Sep;89(9):1096-102. doi: 10.1046/j.1365-2168.2002.02148.x.
PubMed 12190673
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Stenting and Elective Surgery Versus Emergency Surgery for Left-sided Malignant Colonic Obstruction: A Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT00758186
- Acronym / sponsor ID
- Colonic-Stenting-001
- Conditions
- Colorectal Cancer, Intestinal Obstruction
- Keywords
- Colorectal cancer, Endoscopic stent, Intestinal obstruction, Laparoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized controlled trial was to evaluate the role colonic self-expanding metal stent (SEMS) placement as a bridge to surgery in patients with acute malignant left-sided colonic obstruction. The study was designed to test the hypothesis that SEMS placement could be effectively and safely used in this group of patients to relieve colonic obstruction thereby allowing safe recovery and medical stabilization before proceeding to elective surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonic-stenting | Experimental | Procedure: Emergency endoscopic colonic stentingColonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction. |
| Emergency surgery | Active comparator | Procedure: Emergency surgeryEmergency surgery: Patients underwent emergency surgery for acute left-sided malignant colonic obstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute intestinal obstruction secondary to left-sided colonic cancer
Key exclusion criteria (2 listed)
- Distal rectal cancers
- Patients with signs of peritonitis suggestive of bowel perforation
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 |
|---|---|---|
| Emergency endoscopic colonic stentingColonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction. Patients who had successful stenting were discharged and re-admitted for elective surgery. Patients in whom stenting was unsuccessful underwent emergency surgery. The choice of surgery performed was up to the individual consultant colorectal surgeon. | Procedure or surgery | Colonic-stenting |
| Emergency surgeryPatients underwent emergency surgery for acute left-sided malignant colonic obstruction. The choice of surgery performed was up to the individual consultant colorectal surgeon. Surgery included primary resection with or without defunctioning stoma and palliative diverting stoma only. | Procedure or surgery | Emergency surgery |
Primary outcome
The primary endpoint was postoperative complication rates.
Time frame: 30 days
1 secondary outcome
Secondary outcomes evaluated included type of surgery performed, bowel preservation, presence of a stoma, postoperative bowel function, length of hospital stay, and hospitalization costs.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 15714241Lim JF, Tang CL, Seow-Choen F, Heah SM. Prospective, randomized trial comparing intraoperative colonic irrigation with manual decompression only for obstructed left-sided colorectal cancer. Dis Colon Rectum. 2005 Feb;48(2):205-9. doi: 10.1007/s10350-004-0803-9.
- Background: PubMed 14530657Saida Y, Sumiyama Y, Nagao J, Uramatsu M. Long-term prognosis of preoperative "bridge to surgery" expandable metallic stent insertion for obstructive colorectal cancer: comparison with emergency operation. Dis Colon Rectum. 2003 Oct;46(10 Suppl):S44-9. doi: 10.1097/01.DCR.0000087483.63718.A2.
- Background: PubMed 12068202Martinez-Santos C, Lobato RF, Fradejas JM, Pinto I, Ortega-Deballon P, Moreno-Azcoita M. Self-expandable stent before elective surgery vs. emergency surgery for the treatment of malignant colorectal obstructions: comparison of primary anastomosis and morbidity rates. Dis Colon Rectum. 2002 Mar;45(3):401-6. doi: 10.1007/s10350-004-6190-4.
- Background: PubMed 12190673Khot UP, Lang AW, Murali K, Parker MC. Systematic review of the efficacy and safety of colorectal stents. Br J Surg. 2002 Sep;89(9):1096-102. doi: 10.1046/j.1365-2168.2002.02148.x.
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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.
Kok-Sun Ho, FRCSEd principal investigator
Department of Colorectal Surgery, Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Emergency endoscopic colonic stenting and Emergency surgery in people with Colorectal Cancer and Intestinal Obstruction, run by Singapore General Hospital at 1 site in Singapore.
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 1 inclusion and 2 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 primary endpoint was postoperative complication rates. (time frame: 30 days). 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 NCT00758186, which also lists 4 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 18 Apr 2018.