Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01656746
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 41
• Patients Per Site Per Month: 0.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. To report the experience of SILS procedure in the treatment of colorectal disease.

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• 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
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (single incision laparoscopic surgery) Patients undergo single incision laparoscopic surgery with GelPort® attachment.	Procedure: therapeutic laparoscopic surgery; Undergo single incision laparoscopic surgery

Outcome Measures

Primary Outcome Measures

1. Operative time [Up to 1 year]

   Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).

2. Length of skin and fascial incisions [Up to 1 year]

   Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).

3. Estimated blood loss [Up to 1 year]

   Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).

4. 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 [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

1. Quality of life measured using the short form (SF)-12 health related quality of life scale (HQRL) scored using quality metric licensed software [Baseline]

   Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

2. Quality of life measured using the SF-12 HQRL scored using quality metric licensed software [2 weeks]

   Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

3. Quality of life measured using the SF-12 HQRL scored using quality metric licensed software [3 months]

   Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

4. Quality of life measured using the SF-12 HQRL scored using quality metric licensed software [6 months]

   Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

5. Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain [Baseline]

   Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

6. Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain [2 weeks]

   Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

7. Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain [3 months]

   Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

8. Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain [6 months]

   Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

9. Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar" [2 weeks]

   Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

10. Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar" [3 months]

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

11. Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar" [6 months]

    Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Jamesline

Publications

None provided.

• Responsible Party: Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01656746
• Other Study ID Numbers: OSU-09123; NCI-2012-00604
• First Posted: Aug 3, 2012
• Last Update Posted: Dec 6, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Ohio State University Comprehensive Cancer Center: Colorectal Disease; SILS; colorectal surgery
• Additional relevant MeSH terms: Colonic Neoplasms; Adenomatous Polyposis Coli; Adenomatous Polyps; Peutz-Jeghers Syndrome; Crohn Disease; Intestinal Polyposis

Study Results

No Results Posted as of Dec 6, 2017