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Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

Primary Purpose

Adenomatous Polyp, Crohn Disease, Familial Adenomatous Polyposis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
therapeutic laparoscopic surgery
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomatous Polyp focused on measuring Colorectal Disease, SILS, colorectal surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (single incision laparoscopic surgery)

Arm Description

Patients undergo single incision laparoscopic surgery with GelPort® attachment.

Outcomes

Primary Outcome Measures

Operative time
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
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Estimated blood loss
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
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
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
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
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
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
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
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
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
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"
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"
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"
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

Full Information

First Posted
August 1, 2012
Last Updated
December 4, 2017
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01656746
Brief Title
Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease
Official Title
Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Colorectal Disease, SILS, colorectal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (single incision laparoscopic surgery)
Arm Type
Experimental
Arm Description
Patients undergo single incision laparoscopic surgery with GelPort® attachment.
Intervention Type
Procedure
Intervention Name(s)
therapeutic laparoscopic surgery
Intervention Description
Undergo single incision laparoscopic surgery
Primary Outcome Measure Information:
Title
Operative time
Description
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Time Frame
Up to 1 year
Title
Length of skin and fascial incisions
Description
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Time Frame
Up to 1 year
Title
Estimated blood loss
Description
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Time Frame
Up to 1 year
Title
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
Description
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Quality of life measured using the short form (SF)-12 health related quality of life scale (HQRL) scored using quality metric licensed software
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
Baseline
Title
Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
2 weeks
Title
Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
3 months
Title
Quality of life measured using the SF-12 HQRL scored using quality metric licensed software
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
6 months
Title
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
Baseline
Title
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
2 weeks
Title
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
3 months
Title
Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
6 months
Title
Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
2 weeks
Title
Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
3 months
Title
Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"
Description
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Renton, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
Jamesline

Learn more about this trial

Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

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