Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

December 4, 2017 updated by: Ohio State University Comprehensive Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Up to 1 year
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
Time Frame: Up to 1 year
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
Time Frame: Up to 1 year
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
Time Frame: Up to 1 year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Baseline
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
Time Frame: 2 weeks
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
Time Frame: 3 months
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
Time Frame: 6 months
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
Time Frame: Baseline
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
Time Frame: 2 weeks
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
Time Frame: 3 months
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
Time Frame: 6 months
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"
Time Frame: 2 weeks
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"
Time Frame: 3 months
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"
Time Frame: 6 months
Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Renton, MD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OSU-09123
  • NCI-2012-00604 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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