Colonic NeoplasmsPhase 4NCT00654212
Endo-Laparoscopic Approach Versus Conventional Open Surgery in Obstructing Left-sided Colon Cancer: RCT
A Phase 4 study testing endo-laparoscopic approach and open approach in people with Colonic Neoplasms, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- endo-laparoscopic approach and open approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2002to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endo-Laparoscopic Approach Versus Conventional Open Surgery in the Management of Obstructing Left-sided Colon Cancer: A Randomized Trial
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.
Read the 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.
- Conditions
- Colonic Neoplasms
- Being tested
- endo-laparoscopic approach, open approach
- Keywords
- stenting, laparoscopic surgery, colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endo-laparoscopic approachProcedure or surgery
Also called Wallstent Enteral Endoprosthesis
endoluminal stenting followed by laparoscopic resection
open approachProcedure or surgery
Also called laparotomy
emergency open surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | endoluminal stenting followed by laparoscopic resection (endo-laparoscopic limb, the study group) Receives: Procedure: endo-laparoscopic approach |
| 2 | Other | emergency open surgery (open limb, the control group) Receives: Procedure: open approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful one-stage operation
Measured: 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
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startJan 2002
- Primary completionMay 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamela Youde Nethersole Eastern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Yui Shan, Pamela Youde Nethersole Eastern Hospital
- Investigators
- Li Ka Wah, FRCSEd, Study director, PamelaNEH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654212
- Sponsor's protocol ID
- Shan
- Status last verified
- May 2015
- First submitted
- 2 Apr 2008
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20026830
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endo-Laparoscopic Approach Versus Conventional Open Surgery in the Management of Obstructing Left-sided Colon Cancer: A Randomized Trial
- ClinicalTrials.gov ID
- NCT00654212
- Acronym / sponsor ID
- Shan
- Conditions
- Colonic Neoplasms
- Keywords
- stenting, laparoscopic surgery, colon cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pamela Youde Nethersole Eastern HospitalUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- May 2005 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: endo-laparoscopic approachendoluminal stenting followed by laparoscopic resection (endo-laparoscopic limb, the study group) |
| 2 | Other | Procedure: open approachemergency open surgery (open limb, the control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endo-laparoscopic approachAlso: Wallstent Enteral Endoprosthesisendoluminal stenting followed by laparoscopic resection | Procedure or surgery | 1 |
| open approachAlso: laparotomyemergency open surgery | Procedure or surgery | 2 |
Primary outcome
successful one-stage operation
Time frame: till end of the study
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
- Derived from this study: PubMed 20026830Cheung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Ka Wah, FRCSEd study director
PamelaNEH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing endo-laparoscopic approach and open approach in people with Colonic Neoplasms, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful one-stage operation (time frame: till end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00654212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.