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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00654212
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
Cheung Yui Shan, Pamela Youde Nethersole Eastern Hospital

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.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Procedure: endo-laparoscopic approach Procedure: open approach Phase 4

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endo-Laparoscopic Approach Versus Conventional Open Surgery in the Management of Obstructing Left-sided Colon Cancer: A Randomized Trial
Study Start Date : January 2002
Actual Primary Completion Date : May 2005
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Active Comparator: 1
endoluminal stenting followed by laparoscopic resection (endo-laparoscopic limb, the study group)
Procedure: endo-laparoscopic approach
endoluminal stenting followed by laparoscopic resection
Other Name: Wallstent Enteral Endoprosthesis

emergency open surgery (open limb, the control group)
Procedure: open approach
emergency open surgery
Other Name: laparotomy

Primary Outcome Measures :
  1. successful one-stage operation [ Time Frame: till end of the study ]

Secondary Outcome Measures :
  1. cumulative operative time, cumulative blood loss, conversion rate, post-operative pain, cumulative length of hospital stay, operative mortality, post-operative complications, ates of permanent stoma creation,disease recurrence, survival [ Time Frame: end of study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00654212

Hong Kong
Pamela Youde Nethersole Eastern Hosptial
Hong Kong, Hong Kong
Sponsors and Collaborators
Pamela Youde Nethersole Eastern Hospital
Study Director: Li Ka Wah, FRCSEd PamelaNEH

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cheung Yui Shan, Consultant Surgeon, Pamela Youde Nethersole Eastern Hospital Identifier: NCT00654212     History of Changes
Other Study ID Numbers: Shan
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Cheung Yui Shan, Pamela Youde Nethersole Eastern Hospital:
stenting, laparoscopic surgery, colon cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases