Randomized Trial of Colonic Stents as a Bridge to Surgery

This study has been completed.
Sponsor:
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00758186
First received: September 23, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

The objective of this randomized controlled trial was to evaluate the role colonic self-expanding metal stent (SEMS) placement as a bridge to surgery in patients with acute malignant left-sided colonic obstruction. The study was designed to test the hypothesis that SEMS placement could be effectively and safely used in this group of patients to relieve colonic obstruction thereby allowing safe recovery and medical stabilization before proceeding to elective surgery


Condition Intervention Phase
Colorectal Cancer
Intestinal Obstruction
Procedure: Emergency endoscopic colonic stenting
Procedure: Emergency surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Stenting and Elective Surgery Versus Emergency Surgery for Left-Sided Malignant Colonic Obstruction: A Prospective Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • The primary endpoint was postoperative complication rates. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcomes evaluated included type of surgery performed, bowel preservation, presence of a stoma, postoperative bowel function, length of hospital stay, and hospitalization costs. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: October 2004
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colonic-stenting
Colonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction.
Procedure: Emergency endoscopic colonic stenting
Colonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction. Patients who had successful stenting were discharged and re-admitted for elective surgery. Patients in whom stenting was unsuccessful underwent emergency surgery. The choice of surgery performed was up to the individual consultant colorectal surgeon.
Active Comparator: Emergency surgery
Emergency surgery: Patients underwent emergency surgery for acute left-sided malignant colonic obstruction.
Procedure: Emergency surgery
Patients underwent emergency surgery for acute left-sided malignant colonic obstruction. The choice of surgery performed was up to the individual consultant colorectal surgeon. Surgery included primary resection with or without defunctioning stoma and palliative diverting stoma only.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute intestinal obstruction secondary to left-sided colonic cancer

Exclusion Criteria:

  • Distal rectal cancers
  • Patients with signs of peritonitis suggestive of bowel perforation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758186

Locations
Singapore
Department of Colorectal Surgery, Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Kok-Sun Ho, FRCSEd Department of Colorectal Surgery, Singapore General Hospital
  More Information

Publications:
Responsible Party: Dr Kok-Sun Ho, Consultant Surgeon, Department of Colorectal Surgery, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00758186     History of Changes
Other Study ID Numbers: Colonic-Stenting-001
Study First Received: September 23, 2008
Last Updated: September 23, 2008
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
Colorectal cancer
Endoscopic stent
Intestinal obstruction
Laparoscopy

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

ClinicalTrials.gov processed this record on July 28, 2014