Colorectal Cancer Clinical Trial
Official title:
Endoscopic Stenting and Elective Surgery Versus Emergency Surgery for Left-sided Malignant Colonic Obstruction: A Prospective Randomized Trial.
Verified date | April 2018 |
Source | Singapore General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Department of Colorectal Surgery, Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Singapore,
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
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 |
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