Randomized Trial of Colonic Stents as a Bridge to Surgery

Colorectal Cancer Clinical Trial

Official title:

Endoscopic Stenting and Elective Surgery Versus Emergency Surgery for Left-sided Malignant Colonic Obstruction: A Prospective Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758186
• Other study ID #: Colonic-Stenting-001
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2008
• Last updated: April 16, 2018
• Start date: October 2004
• Est. completion date: June 2008

Study information

• Verified date: April 2018
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Intestinal Obstruction

Intervention

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
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.

Locations

Country	Name	City	State
Singapore	Department of Colorectal Surgery, Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint was postoperative complication rates.		30 days
Secondary	Secondary outcomes evaluated included type of surgery performed, bowel preservation, presence of a stoma, postoperative bowel function, length of hospital stay, and hospitalization costs.		3 months