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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

September 23, 2008
September 23, 2008
October 2004
February 2008   (final data collection date for primary outcome measure)
The primary endpoint was postoperative complication rates. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ]
Same as current
 
 
 
Randomized Trial of Colonic Stents as a Bridge to Surgery
Endoscopic Stenting and Elective Surgery Versus Emergency Surgery for Left-Sided Malignant Colonic Obstruction: A Prospective Randomized Trial.

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
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Intestinal 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.
  • 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.
  • 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.
    Intervention: Procedure: Emergency endoscopic colonic stenting
  • Active Comparator: Emergency surgery
    Emergency surgery: Patients underwent emergency surgery for acute left-sided malignant colonic obstruction.
    Intervention: Procedure: Emergency surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00758186
Colonic-Stenting-001
No
Dr Kok-Sun Ho, Consultant Surgeon, Department of Colorectal Surgery, Singapore General Hospital
Singapore General Hospital
 
Principal Investigator: Kok-Sun Ho, FRCSEd Department of Colorectal Surgery, Singapore General Hospital
Singapore General Hospital
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP