Randomized Trial of Colonic Stents as a Bridge to Surgery - Full Text View

Sponsored by:	Singapore General Hospital
Information provided by:	Singapore General Hospital
ClinicalTrials.gov Identifier:	NCT00758186

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Cancer Colorectal Cancer Endoscopy Intestinal Obstruction Surgery

U.S. FDA Resources

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
Colonic-stenting: Experimental 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.
Emergency surgery: Active Comparator 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.

Arms

Assigned Interventions

Colonic-stenting: Experimental

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.

Emergency surgery: Active Comparator

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

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:

Lim JF, Tang CL, Seow-Choen F, Heah SM. Prospective, randomized trial comparing intraoperative colonic irrigation with manual decompression only for obstructed left-sided colorectal cancer. Dis Colon Rectum. 2005 Feb;48(2):205-9.

Saida Y, Sumiyama Y, Nagao J, Uramatsu M. Long-term prognosis of preoperative "bridge to surgery" expandable metallic stent insertion for obstructive colorectal cancer: comparison with emergency operation. Dis Colon Rectum. 2003 Oct;46(10 Suppl):S44-9.

Martinez-Santos C, Lobato RF, Fradejas JM, Pinto I, Ortega-Deballón P, Moreno-Azcoita M. Self-expandable stent before elective surgery vs. emergency surgery for the treatment of malignant colorectal obstructions: comparison of primary anastomosis and morbidity rates. Dis Colon Rectum. 2002 Mar;45(3):401-6.

Khot UP, Lang AW, Murali K, Parker MC. Systematic review of the efficacy and safety of colorectal stents. Br J Surg. 2002 Sep;89(9):1096-102. Review.

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

Keywords provided by Singapore General Hospital:

Colorectal cancer
Endoscopic stent
Intestinal obstruction
Laparoscopy

Study placed in the following topic categories:

Intestinal Obstruction
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Emergencies
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Intestinal Obstruction
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases

Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009