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

This study has been completed.
Sponsor:
Information provided by:
Pamela Youde Nethersole Eastern Hospital
ClinicalTrials.gov Identifier:
NCT00654212
First received: April 2, 2008
Last updated: April 4, 2008
Last verified: January 2008
  Purpose

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 Intervention Phase
Colonic Neoplasms
Procedure: endo-laparoscopic approach
Procedure: open approach
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pamela Youde Nethersole Eastern Hospital:

Primary Outcome Measures:
  • successful one-stage operation [ Time Frame: till end of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: January 2002
Study Completion Date: December 2007
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
2
emergency open surgery (open limb, the control group)
Procedure: open approach
emergency open surgery
Other Name: laparotomy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00654212

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

No publications provided by Pamela Youde Nethersole Eastern Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael, Ka Wah Li/ Chief of Services of Department of Surgery, PamelaYNEH
ClinicalTrials.gov Identifier: NCT00654212     History of Changes
Other Study ID Numbers: Shan
Study First Received: April 2, 2008
Last Updated: April 4, 2008
Health Authority: Hong Kong: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 10, 2014