Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

Crohn Disease Clinical Trial

Official title:

Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656746
• Other study ID #: OSU-09123
• Secondary ID: NCI-2012-00604
• Status: Completed
• Phase: N/A
• First received: August 1, 2012
• Last updated: December 4, 2017
• Start date: May 2010
• Est. completion date: October 2013

Study information

• Verified date: December 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyp
• Adenomatous Polyposis Coli
• Adenomatous Polyps
• Colonic Neoplasms
• Crohn Disease
• Familial Adenomatous Polyposis
• Hereditary Intestinal Polyposis Syndrome
• Intestinal Polyposis
• 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

Intervention

Procedure:
• therapeutic laparoscopic surgery
Undergo single incision laparoscopic surgery

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).	Up to 1 year
Primary	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).	Up to 1 year
Primary	Estimated blood loss	Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).	Up to 1 year
Primary	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).	Up to 1 year
Secondary	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.	Baseline
Secondary	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.	2 weeks
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	Baseline
Secondary	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.	2 weeks
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	2 weeks
Secondary	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.	3 months
Secondary	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.	6 months

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