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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01656746
Other study ID # OSU-09123
Secondary ID NCI-2012-00604
Status Completed
Phase N/A
First received August 1, 2012
Last updated December 4, 2017
Start date May 2010
Est. completion date October 2013

Study information

Verified date December 2017
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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 GelPortĀ® attachment.

After completion of study treatment, patients are followed up at 2 weeks, 3 and 6 months, and at 1 year.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
therapeutic laparoscopic surgery
Undergo single incision laparoscopic surgery

Locations

Country Name City State
United States Ohio State University Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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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