Adenomatous PolypNCT01656746
Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease
A study testing therapeutic laparoscopic surgery in people with Adenomatous Polyp and Crohn Disease, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenomatous Polyp, Crohn Disease, Familial Adenomatous Polyposis
- What is being tested?
- therapeutic laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2013
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are willing to give consent and comply with the evaluation and the treatment schedule
- Patients with disease processes limited to the right colon; this will include Crohn's disease, polyp disease, and cancers of the right colon
- American Society of Anesthesiologists (ASA) =< 3
Who cannot join
- Inability to obtain informed consent
- Previous right colon surgery
- Previous extensive abdominal surgery that would limit the laparoscopic approach
- Stage IV disease at surgery
- Metastatic disease diagnosed by computed tomography (CT), magnetic resonance imaging (MRI), or nuclear imaging
- Patient enrolled in other interventional study
Show all 9Show fewer
- ASA score greater than 3
- Any condition which precludes compliance with the study (Investigator discretion)
- Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases
Read the detailed description
PRIMARY OBJECTIVES:
- To report the experience of SILS procedure in the treatment of colorectal disease.
II. To standardize the SILS technique.
OUTLINE:
Patients undergo single incision laparoscopic surgery with GelPort® attachment.
After completion of study treatment, patients are followed up at 2 weeks, 3 and 6 months, and at 1 year.
- Conditions
- Adenomatous Polyp, Crohn Disease, Familial Adenomatous Polyposis, Hereditary Intestinal Polyposis Syndrome, Recurrent Colon Cancer, Stage I Colon Cancer
- Being tested
- therapeutic laparoscopic surgery
- Keywords
- Colorectal Disease, SILS, colorectal surgery
- Medical subject headings
- Adenomatous Polyps, Crohn Disease, Adenomatous Polyposis Coli, Peutz-Jeghers Syndrome, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic laparoscopic surgeryProcedure or surgery
Undergo single incision laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment (single incision laparoscopic surgery) | Experimental | Patients undergo single incision laparoscopic surgery with GelPort® attachment. Receives: Procedure: therapeutic laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Measured: Up to 1 year
Length of skin and fascial incisions
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Measured: Up to 1 year
Estimated blood loss
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Measured: Up to 1 year
Oncologic sample including size of specimen removed, number of lymph nodes (LN) removed, pathological type and staging, lymph node, vessel or perineural invasion, and status of margins
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Measured: Up to 1 year
Secondary outcomes (11)
Quality of life measured using the short form (SF)-12 health related quality of life scale (HQRL) scored using quality metric licensed software
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: Baseline
Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: 2 weeks
Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: 3 months
Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: 6 months
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: Baseline
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: 2 weeks
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: 3 months
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: 6 months
Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: 2 weeks
Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: 3 months
Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startMay 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous PolypStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Renton, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656746
- Sponsor's protocol ID
- OSU-09123
- Other IDs
- NCI-2012-00604
- Status last verified
- Dec 2017
- First submitted
- 1 Aug 2012
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
- ClinicalTrials.gov ID
- NCT01656746
- Acronym / sponsor ID
- OSU-09123
- Conditions
- Adenomatous Polyp, Crohn Disease, Familial Adenomatous Polyposis, Hereditary Intestinal Polyposis Syndrome, Recurrent Colon Cancer, Stage I Colon Cancer
- Keywords
- Colorectal Disease, SILS, colorectal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 3 Aug 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.
This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases
Detailed description
PRIMARY OBJECTIVES:
- To report the experience of SILS procedure in the treatment of colorectal disease.
II. To standardize the SILS technique.
OUTLINE:
Patients undergo single incision laparoscopic surgery with GelPort® attachment.
After completion of study treatment, patients are followed up at 2 weeks, 3 and 6 months, and at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (single incision laparoscopic surgery) | Experimental | Procedure: therapeutic laparoscopic surgeryPatients undergo single incision laparoscopic surgery with GelPort® attachment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are willing to give consent and comply with the evaluation and the treatment schedule
- Patients with disease processes limited to the right colon; this will include Crohn's disease, polyp disease, and cancers of the right colon
- American Society of Anesthesiologists (ASA) =< 3
Key exclusion criteria (9 listed)
- Inability to obtain informed consent
- Previous right colon surgery
- Previous extensive abdominal surgery that would limit the laparoscopic approach
- Stage IV disease at surgery
- Metastatic disease diagnosed by computed tomography (CT), magnetic resonance imaging (MRI), or nuclear imaging
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 |
|---|---|---|
| therapeutic laparoscopic surgeryUndergo single incision laparoscopic surgery | Procedure or surgery | Treatment (single incision laparoscopic surgery) |
Primary outcome
Operative time
Time frame: Up to 1 year
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Length of skin and fascial incisions
Time frame: Up to 1 year
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Estimated blood loss
Time frame: Up to 1 year
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Oncologic sample including size of specimen removed, number of lymph nodes (LN) removed, pathological type and staging, lymph node, vessel or perineural invasion, and status of margins
Time frame: Up to 1 year
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
11 secondary outcomes
Quality of life measured using the short form (SF)-12 health related quality of life scale (HQRL) scored using quality metric licensed software
Time frame: Baseline
Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
Time frame: 2 weeks
Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
Time frame: 3 months
Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
Time frame: 6 months
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Time frame: Baseline
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Time frame: 2 weeks
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Time frame: 3 months
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Time frame: 6 months
Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
Time frame: 2 weeks
Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
Time frame: 3 months
Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
Time frame: 6 months
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 6 Dec 2017.
- JameslineLink provided by the sponsor.
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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.
David Renton, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic laparoscopic surgery in people with Adenomatous Polyp and Crohn Disease, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 3 inclusion and 9 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 6 Dec 2017. 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 United States. 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.
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?
Operative time (time frame: Up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2017.