NCT00758186

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 colorectal-cancer

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

3.3 years

First QC Date

September 23, 2008

Last Update Submit

April 16, 2018

Conditions

Colorectal CancerIntestinal Obstruction

Keywords

Colorectal cancerEndoscopic stentIntestinal obstructionLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint was postoperative complication rates.

    30 days

Secondary Outcomes (1)

  • 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

Study Arms (2)

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

Emergency surgery

ACTIVE COMPARATOR

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

Procedure: Emergency surgery

Interventions

Emergency endoscopic colonic stentingPROCEDURE

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.

Colonic-stenting
Emergency surgeryPROCEDURE

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.

Emergency surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute intestinal obstruction secondary to left-sided colonic cancer

You may not qualify if:

  • Distal rectal cancers
  • Patients with signs of peritonitis suggestive of bowel perforation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Colorectal Surgery, Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (4)

  • 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.

    PMID: 15714241BACKGROUND

  • 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.

    PMID: 14530657BACKGROUND

  • 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.

    PMID: 12068202BACKGROUND

  • 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.

    PMID: 12190673BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsIntestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Kok-Sun Ho, FRCSEd

    Department of Colorectal Surgery, Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

October 1, 2004

Primary Completion

February 1, 2008

Study Completion

June 1, 2008

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

SG(1)