Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

Not Applicable

Completed

• Conditions: Adenomatous Polyp; Stage I Colon Cancer; Stage IIA Colon Cancer; Stage IIIB Colon Cancer; Familial Adenomatous Polyposis; Recurrent Colon Cancer; Stage IIIA Colon Cancer; Crohn Disease; Hereditary Intestinal Polyposis Syndrome; Stage IIC Colon Cancer
• Interventions: Procedure: therapeutic laparoscopic surgery

• Registration Number: NCT01656746
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-03
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (single incision laparoscopic surgery)	therapeutic laparoscopic surgery	Patients undergo single incision laparoscopic surgery with GelPort® attachment.

Primary Outcome Measures

Name	Time	Method
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).
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).
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).
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

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States