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Randomized Trial of Colonic Stents as a Bridge to Surgery

Primary Purpose

Colorectal Cancer, Intestinal Obstruction

Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Emergency endoscopic colonic stenting
Emergency surgery
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, Endoscopic stent, Intestinal obstruction, Laparoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Colorectal Surgery, Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Colonic-stenting

Emergency surgery

Arm Description

Colonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction.

Emergency surgery: Patients underwent emergency surgery for acute left-sided malignant colonic obstruction.

Outcomes

Primary Outcome Measures

The primary endpoint was postoperative complication rates.

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.

Full Information

First Posted
September 23, 2008
Last Updated
April 16, 2018
Sponsor
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00758186
Brief Title
Randomized Trial of Colonic Stents as a Bridge to Surgery
Official Title
Endoscopic Stenting and Elective Surgery Versus Emergency Surgery for Left-sided Malignant Colonic Obstruction: A Prospective Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Intestinal Obstruction
Keywords
Colorectal cancer, Endoscopic stent, Intestinal obstruction, Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colonic-stenting
Arm Type
Experimental
Arm Description
Colonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction.
Arm Title
Emergency surgery
Arm Type
Active Comparator
Arm Description
Emergency surgery: Patients underwent emergency surgery for acute left-sided malignant colonic obstruction.
Intervention Type
Procedure
Intervention Name(s)
Emergency endoscopic colonic stenting
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Emergency surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint was postoperative complication rates.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kok-Sun Ho, FRCSEd
Organizational Affiliation
Department of Colorectal Surgery, Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Colorectal Surgery, Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
15714241
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. doi: 10.1007/s10350-004-0803-9.
Results Reference
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PubMed Identifier
14530657
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. doi: 10.1097/01.DCR.0000087483.63718.A2.
Results Reference
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PubMed Identifier
12068202
Citation
Martinez-Santos C, Lobato RF, Fradejas JM, Pinto I, Ortega-Deballon 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. doi: 10.1007/s10350-004-6190-4.
Results Reference
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PubMed Identifier
12190673
Citation
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. doi: 10.1046/j.1365-2168.2002.02148.x.
Results Reference
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Randomized Trial of Colonic Stents as a Bridge to Surgery

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