Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

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

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

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Familial Adenomatous Polyposis; Stage IIIA Colon Cancer; Stage IIIB Colon Cancer; Stage IIIC Colon Cancer; Recurrent Colon Cancer; Stage I Colon Cancer; Stage IIA Colon Cancer; Stage IIB Colon Cancer; Stage IIC Colon Cancer; Adenomatous Polyp; Hereditary Intestinal Polyposis Syndrome
• Intervention / Treatment: Procedure: therapeutic 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: David Renton, MD, Ohio State University

Publications and helpful links

Helpful Links

• Jamesline

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (ESTIMATE): August 3, 2012

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: colorectal surgery; SILS; Colorectal Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Neoplastic Syndromes, Hereditary; Inflammatory Bowel Diseases; Adenoma; Hyperpigmentation; Pigmentation Disorders; Melanosis; Lentigo; Crohn Disease; Adenomatous Polyposis Coli; Colonic Neoplasms; Adenomatous Polyps; Peutz-Jeghers Syndrome; Intestinal Polyposis
• Other Study ID Numbers: OSU-09123; NCI-2012-00604 (REGISTRY: CTRP (Clinical Trial Reporting Program))