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Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Renton, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01656746
First received: August 1, 2012
Last updated: November 4, 2013
Last verified: November 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 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 ] [ 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.


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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: David Renton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01656746     History of Changes
Other Study ID Numbers: OSU-09123, NCI-2012-00604
Study First Received: August 1, 2012
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014