Rectal CancerPhase 4NCT01579721
Prospective Randomized Study of SILS Versus CLS for Rectal Cancer
A Phase 4 study testing Single Incision Laparoscopic Surgery in people with Rectal Cancer and Adenocarcinoma, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Adenocarcinoma
- What is being tested?
- Single Incision Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Oct 2012
- 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
- Patients > 18 years of age.
- ASA I-III.
- Tumor-location: maximum 15 cm from the anal verge.
- No involvement of neighbouring organs.
- No distant metastasis.
Who cannot join
- Linguistic, physical or psychological barriers precluding oral and written consent.
- History of intestinal surgery (excl. appendectomy).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Gastroentestinal Surgery, Hvidovre Hospital
Hvidovre, DK-2650
About this study
Official title: Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer
Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery.
Design: randomized, prospective clinical study Patients: 40 patients
- Conditions
- Rectal Cancer, Adenocarcinoma
- Being tested
- Single Incision Laparoscopic Surgery
- Medical subject headings
- Rectal Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Incision Laparoscopic SurgeryProcedure or surgery
Single incision laparoscopic surgery for rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| SILS-group | Experimental | 20 patients undergoing Single Incision Laparoscopic Surgery Receives: Procedure: Single Incision Laparoscopic Surgery |
| CLS-group | No intervention | 20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity
The purpose of this study is to compare 30-days postoperative morbidity between the two groups
Measured: 30 days
Secondary outcomes (3)
immunology
to compare results of blood-samples (C-reactive protein, leucocyte-count and interleukin-6) 72 hours postoperatively between the two groups
Measured: 72 hours postoperatively
postoperative outcome
to compare postoperative results (postoperative pain, time to bowel function, time to regain full diet and mobilisation) between the two groups.
Measured: 5 days postoperatively
oncology
Comparison of the oncological results (quality of specimen, completeness of mesorectal fascia, circumferential resection margin, number of harvested lymphnodes, TNM-classification) between the two groups.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
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 Rectal CancerStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrine Kanstrup Aslak, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579721
- Sponsor's protocol ID
- SILS rectal cancer
- Status last verified
- Feb 2013
- First submitted
- 16 Apr 2012
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bulut O, Aslak KK, Levic K, Nielsen CB, Romer E, Sorensen S, Christensen IJ, Nielsen HJ. A randomized pilot study on single-port versus conventional laparoscopic rectal surgery: effects on postoperative pain and the stress response to surgery. Tech Coloproctol. 2015 Jan;19(1):11-22. doi: 10.1007/s10151-014-1237-6. Epub 2014 Nov 8.
PubMed 25380743
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer
- ClinicalTrials.gov ID
- NCT01579721
- Acronym / sponsor ID
- SILS rectal cancer
- Conditions
- Rectal Cancer, Adenocarcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Apr 2012 (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.
Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery.
Design: randomized, prospective clinical study Patients: 40 patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SILS-group | Experimental | Procedure: Single Incision Laparoscopic Surgery20 patients undergoing Single Incision Laparoscopic Surgery |
| CLS-group | No intervention | –20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients > 18 years of age.
- ASA I-III.
- Tumor-location: maximum 15 cm from the anal verge.
- No involvement of neighbouring organs.
- No distant metastasis.
Key exclusion criteria (2 listed)
- Linguistic, physical or psychological barriers precluding oral and written consent.
- History of intestinal surgery (excl. appendectomy).
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 |
|---|---|---|
| Single Incision Laparoscopic SurgerySingle incision laparoscopic surgery for rectal cancer | Procedure or surgery | SILS-group |
Primary outcome
morbidity
Time frame: 30 days
The purpose of this study is to compare 30-days postoperative morbidity between the two groups
3 secondary outcomes
immunology
Time frame: 72 hours postoperatively
postoperative outcome
Time frame: 5 days postoperatively
oncology
Time frame: 30 days
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 Feb 2013.
- Derived from this study: PubMed 25380743Bulut O, Aslak KK, Levic K, Nielsen CB, Romer E, Sorensen S, Christensen IJ, Nielsen HJ. A randomized pilot study on single-port versus conventional laparoscopic rectal surgery: effects on postoperative pain and the stress response to surgery. Tech Coloproctol. 2015 Jan;19(1):11-22. doi: 10.1007/s10151-014-1237-6. Epub 2014 Nov 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Single Incision Laparoscopic Surgery in people with Rectal Cancer and Adenocarcinoma, run by Hvidovre University Hospital at 1 site in Denmark.
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 5 inclusion and 2 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 Feb 2013. 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 Denmark. 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?
morbidity (time frame: 30 days). 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 NCT01579721, 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 Feb 2013.