Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicentre randomised trial
| ISRCTN | ISRCTN46462267 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46462267 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Funder | Academic Medical Center (AMC) (The Netherlands) |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 10/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ilja Peute
Scientific
Scientific
Academic Medical Center
Department of Gastroenterology, C2
P.O. Box 22700
Amsterdam
1100 DE
Netherlands
| Phone | +31 (0)63 002 3579 |
|---|---|
| info@stent-in.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled parallel-group multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Stent-in 2 study |
| Study objectives | Which treatment strategy is the most effective for patients with acute left-sided malignant colonic obstruction: either colonic stenting followed by elective surgery or emergency surgery. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Acute left-sided malignant colonic obstruction |
| Intervention | Patients will be randomised to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. |
| Intervention type | Other |
| Primary outcome measure(s) |
Effectiveness of both strategies in terms of quality of life, morbidity and mortality. |
| Key secondary outcome measure(s) |
Costs of both strategies. |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Symptoms of left-sided malignant colonic obstruction existing less than one week defined as obstructive symptoms with dilation of the colon on plain abdominal X-ray and typical abnormalities on a gastrografin enema study compatible with a malignant colonic stricture 2. Aged more than 18 years 3. Informed consent |
| Key exclusion criteria | 1. Peritonitis, perforation, fever, sepsis or other serious complications demanding urgent surgery 2. American Society of Anesthesiologists (ASA) IV or V 3. Obstruction due to non-colonic malignancies or from a benign origin 4. Distal tumor margin less than 10 cm from the anal verge |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DE
Netherlands
1100 DE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No | |
| Results article | results | 01/12/2014 | Yes | No | |
| Protocol article | protocol | 03/07/2007 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
