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
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Ilja Peute
Scientific

Academic Medical Center
Department of Gastroenterology, C2
P.O. Box 22700
Amsterdam
1100 DE
Netherlands

Phone	+31 (0)63 002 3579
Email	info@stent-in.nl

Study design	Randomised controlled parallel-group multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Effectiveness of both strategies in terms of quality of life, morbidity and mortality.
Secondary outcome measures	Costs of both strategies.
Overall study start date	01/01/2007
Completion date	01/01/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	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

Academic Medical Center

Amsterdam
1100 DE
Netherlands

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.uva.nl/#http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Hospital/treatment centre

Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	03/07/2007	Yes	No
Results article	results	01/04/2011	Yes	No
Results article	results	01/12/2014	Yes	No