Trial Information

Prospective, Randomised European Multicentric Study, Comparing Enteral Stent Followed by Elective Surgery Versus Emergency Surgical Treatment in Malignant Colonic Obstruction

Introduction & background In emergency surgery, although surgical and resuscitation
techniques were improved, the postoperative complications and mortality rates are still high
and however higher than for those patients that underwent to elective surgery (1-3). Using a
Metallic prosthesis stent in an obstructed colon allows to transform an emergency surgical
case into an elective surgery case. This allows to restore the bowel transit and to operate
in elective condition reducing morbidity, mortality and the need of an enterostomy (4-10).

Although there are recent outcomes on literature about use of a decompressive stent before
surgery in obstructed patients from malignant colic tumours, there are no prospective and
randomised studies were stent positioning followed by elective surgery is compared with
emergency surgery.

Study design Prospective, randomized multicentric clinical trial where samples are patients
with emergency room diagnosis of obstructing colonic neoplasm.

Once informed and obtained consent, patients will be included in the study and randomized in
one of the two branches of the study: A.- enteral stent positioning followed by second time
resection in the same hospital stay. B.- emergency surgical treatment consisting in Hartmann
operation or resection with same time anastomosis. Results from transit reconstruction in
patients underwent Hartmann operation will be considered in the study.

Short term clinical evolution control in order to determine postoperative morbility and
mortality, hospital stay.

Follow-up will be performed to evaluate survival rate and disease free survival.

Endpoints To evaluate and compare the results obtained using enteral stent followed by
elective surgery versus common emergency surgical techniques.

Primary endpoint will be 60 days postoperative morbidity. Others endpoints will be:
postoperative mortality, length of hospital stay, need for analgesia. Long term follow up
with specific instrumental controls (CT scan, US, colonoscopy or RX clysma) to identify
disease recurrences or metastases as cost analysis and patient's quality of life will also
be evaluated.

Statistics & randomization In prospective series analysed in different centres, the
incidence of postoperative complications in patients underwent to emergency colonic surgery
was 35%. The positioning of the stent associated to second time surgical elective treatment
is characterized by 15% of morbidity (stent: 5%, surgery: 10%). The number of patients
needed to carry on the study making statistically significant this difference (35% vs 15%)
with an error alpha = 0.05 and beta = 0.2 and estimating a loss of 5% of the samples, is 72
patients in each group.

Randomization will be stratified for local extension of tumour (T4 vs others) and for
presence or not of liver metastases.

Main selection criteria Inclusion of patients with malignant colonic obstruction localized
between promontorium and splenic flexure and diagnosed by CTScan. Those patients with
peritonitis, pneumoperitoneum, synchronic colonic tumour, pregnant or haemodynamic
instability will be excluded.

Follow-up Same follow-up as patients diagnosed and treated for Colon Cancer following the
protocol of each center, never less than 3 years. During follow-up required complementary
studies will be performed in each case in order to evaluate local recurrence or distant
metastases. Also quality of life and costs will be evaluated.

Expected results: reduction of postoperative complications and hospital stay in patients
submitted to stent positioning without worsening of evolution of the neoplastic illness.