Endo-Laparoscopic Approach Versus Conventional Open Surgery in Obstructing Left-sided Colon Cancer: RCT

NCT ID: NCT00654212

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2007-12-31

Brief Summary

Objective: Whether temporary endoscopic decompression by Self-expanding metal stents (SEMS) could allow these patients to undergo successful laparoscopic resection (endo-laparoscopic approach) has never been previously studied. This randomized trial aims to compare this approach with emergency open surgery in the management of obstructing left-sided colon cancer.

Detailed Description

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.

Conditions

Colonic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

endoluminal stenting followed by laparoscopic resection (endo-laparoscopic limb, the study group)

Group Type: ACTIVE_COMPARATOR

endo-laparoscopic approach

Intervention Type: PROCEDURE

endoluminal stenting followed by laparoscopic resection

2

emergency open surgery (open limb, the control group)

Group Type: OTHER

open approach

Intervention Type: PROCEDURE

emergency open surgery

Interventions

endo-laparoscopic approach

endoluminal stenting followed by laparoscopic resection

Intervention Type: PROCEDURE

open approach

emergency open surgery

Intervention Type: PROCEDURE

Other Intervention Names

Wallstent Enteral Endoprosthesis; laparotomy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamela Youde Nethersole Eastern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cheung Yui Shan

Consultant Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Ka Wah, FRCSEd

Role: STUDY_DIRECTOR

PamelaNEH

Locations

Pamela Youde Nethersole Eastern Hosptial

Hong Kong, , Hong Kong

Countries

Hong Kong

References

Cheung HY, Chung CC, Tsang WW, Wong JC, Yau KK, Li MK. Endolaparoscopic approach vs conventional open surgery in the treatment of obstructing left-sided colon cancer: a randomized controlled trial. Arch Surg. 2009 Dec;144(12):1127-32. doi: 10.1001/archsurg.2009.216.

Reference Type: DERIVED

PMID: 20026830 (View on PubMed)

Other Identifiers

Shan

Identifier Type: -

Identifier Source: org_study_id