NCT00654212

Brief Summary

Objective: Whether temporary endoscopic decompression by Self-expanding metal stents (SEMS) could allow these patients to undergo successful laparoscopic resection (endo-laparoscopic approach) has never been previously studied. This randomized trial aims to compare this approach with emergency open surgery in the management of obstructing left-sided colon cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_4

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

January 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

3.3 years

First QC Date

April 2, 2008

Last Update Submit

May 3, 2015

Conditions

Colonic Neoplasms

Keywords

stenting, laparoscopic surgery, colon cancer

Outcome Measures

Primary Outcomes (1)

  • successful one-stage operation

    till end of the study

Secondary Outcomes (1)

  • cumulative operative time, cumulative blood loss, conversion rate, post-operative pain, cumulative length of hospital stay, operative mortality, post-operative complications, ates of permanent stoma creation,disease recurrence, survival

    end of study

Study Arms (2)

1

ACTIVE COMPARATOR

endoluminal stenting followed by laparoscopic resection (endo-laparoscopic limb, the study group)

Procedure: endo-laparoscopic approach

2

OTHER

emergency open surgery (open limb, the control group)

Procedure: open approach

Interventions

endo-laparoscopic approachPROCEDURE

endoluminal stenting followed by laparoscopic resection

Also known as: Wallstent Enteral Endoprosthesis
1
open approachPROCEDURE

emergency open surgery

Also known as: laparotomy
2

Eligibility Criteria

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

You may qualify if:

  • Consecutive adult patients (aged 18 or above) presenting with clinical features of left colonic obstruction were potential candidates.
  • In the absence of peritonitis, right lower quadrant tenderness or grossly distended caecum (10cm or above in maximal dimension) on plain abdominal radiograph, an urgent water-soluble single contrast enema was performed to determine the level of obstruction within 24 hours of admission.
  • Patients were recruited if the lower border of an obstructing tumour was found between the splenic flexure and rectosigmoid junction.
  • Informed consent was obtained from every patient recruited in the trial.

You may not qualify if:

  • Patients who did not give informed consent
  • Patients who were considered unfit for operative treatment
  • Patients with previous laparotomy
  • Patients with clinically palpable tumor on abdominal examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamela Youde Nethersole Eastern Hosptial

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Cheung HY, Chung CC, Tsang WW, Wong JC, Yau KK, Li MK. Endolaparoscopic approach vs conventional open surgery in the treatment of obstructing left-sided colon cancer: a randomized controlled trial. Arch Surg. 2009 Dec;144(12):1127-32. doi: 10.1001/archsurg.2009.216.

    PMID: 20026830DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Laparotomy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Li Ka Wah, FRCSEd

    PamelaNEH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 7, 2008

Study Start

January 1, 2002

Primary Completion

May 1, 2005

Study Completion

December 1, 2007

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

HK(1)