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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Undergo single incision laparoscopic surgery
Ohio State University Medical Center
Columbus, Ohio, United States
Operative time
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Up to 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
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
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
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
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
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
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
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"
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
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"
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
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"
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.