Crohn Disease Clinical Trial
Official title:
Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
Verified date | December 2017 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operative time | Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data). | Up to 1 year | |
Primary | 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). | Up to 1 year | |
Primary | Estimated blood loss | Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data). | Up to 1 year | |
Primary | 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). | Up to 1 year | |
Secondary | 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. | Baseline | |
Secondary | 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. | 2 weeks | |
Secondary | 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. | 3 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | Baseline | |
Secondary | 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. | 2 weeks | |
Secondary | 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. | 3 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 2 weeks | |
Secondary | 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. | 3 months | |
Secondary | 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. | 6 months |
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