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