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Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in II study)

Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in II study) - Stent-in II

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29875
Enrollment
120
Registered
2006-08-11
Start date
2007-01-01
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant left-sided colonic obstruction malignant obstruction of the left colon

Interventions

Patients will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: *Peritonitis, perforation, fever, sepsis or other serious complications demanding urgent surgery *ASA IV or V *Obstruction due to non-colonic malignancies or from a benign origin *Distal tumor margin less than 10 cm from the anal verge *Incapable of completing self-report quality of life questionnaires

Design outcomes

Primary

MeasureTime frame
We will compare the effectiveness of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with the following standardized questionnaires: EORTC QLQ-C30, the colorectal cancer specific EORTC QLQ-CR38 and the EuroQol. Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality.

Secondary

MeasureTime frame
As secundary outcome parameters we will compare costs of both strategies.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)