study details
start date: May 2010
estimated completion: October 2013
last updated: December 6, 2017
phase of development: Not Available
size / enrollment: 10
study design:
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
study description:
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.
primary outcomes:
- Operative time [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
inclusion criteria:
• Eligible Sexes:
1. Patients who are willing to give consent and comply with the evaluation and the treatment schedule
2. Patients with disease processes limited to the right colon; this will include Crohn's disease, polyp disease, and cancers of the right colon
3. American Society of Anesthesiologists (ASA) =< 3
exclusion criteria:
1. Inability to obtain informed consent
2. Previous right colon surgery
3. Previous extensive abdominal surgery that would limit the laparoscopic approach
4. Stage IV disease at surgery
5. Metastatic disease diagnosed by computed tomography (CT), magnetic resonance imaging (MRI), or nuclear imaging
6. Patient enrolled in other interventional study
7. ASA score greater than 3
8. Any condition which precludes compliance with the study (Investigator discretion)
9. 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
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