Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease
This study is currently recruiting participants.
Verified August 2012 by Ohio State University Comprehensive Cancer Center
Sponsor:
David Renton
Information provided by (Responsible Party):
David Renton, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01656746
First received: August 1, 2012
Last updated: August 2, 2012
Last verified: August 2012
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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.
| Estimated Enrollment: | 15 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656746
Contacts
| Contact: Ohio State University Comprehensive Cancer Center | 1-800-293-5066 | jamesline@osumc.edu |
Locations
| United States, Ohio | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: David Renton, MD 614-257-2264 david.renton@osumc.edu | |
| Principal Investigator: David Renton, MD | |
Sponsors and Collaborators
David Renton
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: | August 2, 2012 |
| 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:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013