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Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01656746
First Posted: August 3, 2012
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
  Purpose
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

Condition Intervention
Adenomatous Polyp Crohn Disease Familial Adenomatous Polyposis Hereditary Intestinal Polyposis Syndrome Recurrent Colon Cancer Stage I Colon Cancer Stage IIA Colon Cancer Stage IIB Colon Cancer Stage IIC Colon Cancer Stage IIIA Colon Cancer Stage IIIB Colon Cancer Stage IIIC Colon Cancer Procedure: therapeutic laparoscopic surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: May 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (single incision laparoscopic surgery)
Patients undergo single incision laparoscopic surgery with GelPort® attachment.
Procedure: therapeutic laparoscopic surgery
Undergo single incision laparoscopic surgery

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656746


Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: David Renton, MD Ohio State University
  More Information

Additional Information:
Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01656746     History of Changes
Other Study ID Numbers: OSU-09123
NCI-2012-00604 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: August 1, 2012
First Posted: August 3, 2012
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by Ohio State University Comprehensive Cancer Center:
Colorectal Disease
SILS
colorectal surgery

Additional relevant MeSH terms:
Colonic Neoplasms
Crohn Disease
Adenomatous Polyposis Coli
Adenomatous Polyps
Intestinal Polyposis
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn