Endo-Laparoscopic Approach Versus Conventional Open Surgery in Obstructing Left-sided Colon Cancer: RCT
Primary Purpose
Colonic Neoplasms
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
endo-laparoscopic approach
open approach
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Neoplasms focused on measuring stenting, laparoscopic surgery, colon cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Pamela Youde Nethersole Eastern Hosptial
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
1
2
Arm Description
endoluminal stenting followed by laparoscopic resection (endo-laparoscopic limb, the study group)
emergency open surgery (open limb, the control group)
Outcomes
Primary Outcome Measures
successful one-stage operation
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00654212
First Posted
April 2, 2008
Last Updated
May 3, 2015
Sponsor
Pamela Youde Nethersole Eastern Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00654212
Brief Title
Endo-Laparoscopic Approach Versus Conventional Open Surgery in Obstructing Left-sided Colon Cancer: RCT
Official Title
Endo-Laparoscopic Approach Versus Conventional Open Surgery in the Management of Obstructing Left-sided Colon Cancer: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamela Youde Nethersole Eastern Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Introduction:
First reported in 1991, laparoscopic assisted colectomy is increasingly practised world-wide. Abundant evidence exists in the literature suggesting laparoscopic assisted colectomy, when compared with its open counterpart, is associated with more favourable short-term outcomes, better cosmesis, and better patient's satisfaction. Moreover, recent reports from large-scale randomized trials support the use of this minimally invasive technique in the treatment of colorectal cancer, a malignant condition common in many parts of the world. However, around 8-29% of patients with colorectal cancer present as acute large bowel obstruction, a condition used to be considered as a contraindication to laparoscopic surgery due to poor exposure and potential hazard of injury to the distended bowel. Thus, most cases of malignant large bowel obstruction mandate an emergency open surgery to relieve the obstruction and resect the tumour, with many patients, especially those with obstructing left-sided colon cancer, ending up with temporary or permanent stoma which can adversely affect their health-related quality of life.
Self-expanding metal stents (SEMS) was first described by Dohmoto in 1991 as an endoscopic palliative alternative for treating inoperable colon cancer. Three years later, Tejero et al. published a preliminary report of using SEMS as a 'bridge' to surgery in two patients with colonic obstruction 13. Since then, a number of publications as well as systemic review have shown that endoluminal stenting is a relatively simple and safe alternative to standard surgical management of acute malignant obstruction of the left colon, thereby obviating the need of emergency surgery or colostomy. However, whether temporary endoscopic bowel decompression by SEMS could allow patients with malignant left colonic obstruction to undergo successful laparoscopic resection (endo-laparoscopic approach) has never been studied in detail before. We therefore conducted the current trial to study the outcomes of this endo-laparoscopic approach in patients with obstructing left-sided colon cancer.
Patients and Methods:
This study is a randomized controlled trial designed to evaluate the outcomes of the endo-laparoscopic approach for patients with obstructing left-sided colon cancer, using patients undergoing emergency open surgery as controls. Only patients with obstructing left-sided colon cancer were studied because of the reported high incidence of stoma creation in this condition10,11, and because a homogeneous group of patients could be ensured to facilitate comparison of the two different approaches. A single surgical team consisting of two surgeons (C.C.C. and M.K.W.L.) and one camera assistant in the case of laparoscopic resection performed all operations with the patient under general anesthesia. The study was approved by the hospital ethical committee and was not supported by any commercial funds or sponsorship.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
stenting, laparoscopic surgery, colon cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
endoluminal stenting followed by laparoscopic resection (endo-laparoscopic limb, the study group)
Arm Title
2
Arm Type
Other
Arm Description
emergency open surgery (open limb, the control group)
Intervention Type
Procedure
Intervention Name(s)
endo-laparoscopic approach
Other Intervention Name(s)
Wallstent Enteral Endoprosthesis
Intervention Description
endoluminal stenting followed by laparoscopic resection
Intervention Type
Procedure
Intervention Name(s)
open approach
Other Intervention Name(s)
laparotomy
Intervention Description
emergency open surgery
Primary Outcome Measure Information:
Title
successful one-stage operation
Time Frame
till end of the study
Secondary Outcome Measure Information:
Title
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
Time Frame
end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Ka Wah, FRCSEd
Organizational Affiliation
PamelaNEH
Official's Role
Study Director
Facility Information:
Facility Name
Pamela Youde Nethersole Eastern Hosptial
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
20026830
Citation
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.
Results Reference
derived
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Endo-Laparoscopic Approach Versus Conventional Open Surgery in Obstructing Left-sided Colon Cancer: RCT
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