To compare colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in terms of health-related quality of life, morbidity and mortality.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
As secundary outcome parameters we will compare costs of both strategies.
Background summary
Conventionally patients with acute malignant colonic obstruction are treated
with emergency surgery to restore luminal patency. These emergency operations
have a mortality rate of 15-34% and a morbidity rate of 32-64%. Since the early
1990s colonic stenting has been introduced, mainly in the left-sided colon, to
restore luminal patency. It can be applied as a preoperative treatment to
prepare patients for elective surgery as well as a definitive palliative
procedure in patients with incurable disease. In uncontrolled studies stent
placement before elective surgery has been suggested to improve the patient*s
clinical condition, decreasing mortality, morbidity and number of colostomies.
Complications related to stent placement include perforation (4%), stent
migration (11.8%) and re-obstruction (7.3%) causing a cumulative mortality of
0.58%. It has to be underlined that stent perforation can lead to peritoneal
tumor spill, changing a potentially curable disease in an incurable one. To
date a direct comparison between the treatment with self-expandable stents
before elective surgery and emergency surgery for malignant acute colorectal
obstruction has not been published.
Study objective
To compare colonic stenting followed by elective surgery with emergency surgery
for the management of acute left-sided malignant colonic obstruction in terms
of health-related quality of life, morbidity and mortality.
Study design
A multicenter prospective randomized controlled trial.
Intervention
Patients will be randomized to either emergency surgery (current standard
treatment) or colonic stenting as bridge to elective surgery.
Study burden and risks
With the exception of filling out the quality of life questionnaires (EORTC
QLQ-C30, EORTC QLQ-CR38 and EuroQol) there is no additional load or risk for
the patients they would have had if they would be treated according to the
current gold standard (emergency surgery).
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
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
*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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12741.018.06 |