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Endo-Laparoscopic Approach Versus Conventional Open Surgery in the Management of Obstructing Left-Sided Colon Cancer: A Randomized Trial


Phase 4
18 Years
N/A
Not Enrolling
Both
Colonic Neoplasms

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Trial Information

Endo-Laparoscopic Approach Versus Conventional Open Surgery in the Management of Obstructing Left-Sided Colon Cancer: A Randomized Trial


Introduction:

First reported in 1991, laparoscopic assisted colectomy is increasingly practised
world-wide. Abundant evidence exists in the literature suggesting laparoscopic assisted
colectomy, when compared with its open counterpart, is associated with more favourable
short-term outcomes, better cosmesis, and better patient's satisfaction. Moreover, recent
reports from large-scale randomized trials support the use of this minimally invasive
technique in the treatment of colorectal cancer, a malignant condition common in many parts
of the world. However, around 8-29% of patients with colorectal cancer present as acute
large bowel obstruction, a condition used to be considered as a contraindication to
laparoscopic surgery due to poor exposure and potential hazard of injury to the distended
bowel. Thus, most cases of malignant large bowel obstruction mandate an emergency open
surgery to relieve the obstruction and resect the tumour, with many patients, especially
those with obstructing left-sided colon cancer, ending up with temporary or permanent stoma
which can adversely affect their health-related quality of life.

Self-expanding metal stents (SEMS) was first described by Dohmoto in 1991 as an endoscopic
palliative alternative for treating inoperable colon cancer. Three years later, Tejero et
al. published a preliminary report of using SEMS as a 'bridge' to surgery in two patients
with colonic obstruction 13. Since then, a number of publications as well as systemic
review have shown that endoluminal stenting is a relatively simple and safe alternative to
standard surgical management of acute malignant obstruction of the left colon, thereby
obviating the need of emergency surgery or colostomy. However, whether temporary endoscopic
bowel decompression by SEMS could allow patients with malignant left colonic obstruction to
undergo successful laparoscopic resection (endo-laparoscopic approach) has never been
studied in detail before. We therefore conducted the current trial to study the outcomes of
this endo-laparoscopic approach in patients with obstructing left-sided colon cancer.

Patients and Methods:

This study is a randomized controlled trial designed to evaluate the outcomes of the
endo-laparoscopic approach for patients with obstructing left-sided colon cancer, using
patients undergoing emergency open surgery as controls. Only patients with obstructing
left-sided colon cancer were studied because of the reported high incidence of stoma
creation in this condition10,11, and because a homogeneous group of patients could be
ensured to facilitate comparison of the two different approaches. A single surgical team
consisting of two surgeons (C.C.C. and M.K.W.L.) and one camera assistant in the case of
laparoscopic resection performed all operations with the patient under general anesthesia.
The study was approved by the hospital ethical committee and was not supported by any
commercial funds or sponsorship.


Inclusion Criteria:



- Consecutive adult patients (aged 18 or above) presenting with clinical features of
left colonic obstruction were potential candidates.

- In the absence of peritonitis, right lower quadrant tenderness or grossly distended
caecum (10cm or above in maximal dimension) on plain abdominal radiograph, an urgent
water-soluble single contrast enema was performed to determine the level of
obstruction within 24 hours of admission.

- Patients were recruited if the lower border of an obstructing tumour was found
between the splenic flexure and rectosigmoid junction.

- Informed consent was obtained from every patient recruited in the trial.

Exclusion Criteria:

- Patients who did not give informed consent

- Patients who were considered unfit for operative treatment

- Patients with previous laparotomy

- Patients with clinically palpable tumor on abdominal examination.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

successful one-stage operation

Outcome Time Frame:

till end of the study

Safety Issue:

Yes

Principal Investigator

Li Ka Wah, FRCSEd

Investigator Role:

Study Director

Investigator Affiliation:

PamelaNEH

Authority:

Hong Kong: Ethics Committee

Study ID:

Shan

NCT ID:

NCT00654212

Start Date:

January 2002

Completion Date:

December 2007

Related Keywords:

  • Colonic Neoplasms
  • stenting, laparoscopic surgery, colon cancer
  • Neoplasms
  • Colonic Neoplasms

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