Clinical Trial: Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
Brief 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
Detailed Summary:
PRIMARY OBJECTIVES:
I. 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.
Sponsor: Ohio State University Comprehensive Cancer Center
Current 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).
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
- Quality of life measured using the SF-12 HQRL scored using quality metric licensed software [ Time Frame: 2 weeks ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
- Quality of life measured using the SF-12 HQRL scored using quality metric licensed software [ Time Frame: 3 months ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
- Quality of life measured using the SF-12 HQRL scored using quality metric licensed software [ Time Frame: 6 months ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
- 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 ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
- 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 ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
- 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 ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
- 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 ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
- 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 ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
- 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 ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
- 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 ]Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Original Secondary Outcome: Same as current
Information By: Ohio State University Comprehensive Cancer Center
Dates:
Date Received: August 1, 2012
Date Started: May 2010
Date Completion:
Last Updated: November 4, 2013
Last Verified: November 2013