Colorectal PolypsNCT00725465
Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions
An observational study of Colorectal Polyps, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate prospectively the usefulness of IC-CO2(intraoperative colonoscopy (IC) using carbon dioxide (CO2)) in colon and rectal surgical practice, coincident with laparoscopic surgery, and assess whether it provides useful information that influences the type of surgical therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Polyps
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions such as neoplasm or rectal prolapse managed with intra-operative carbon dioxide (co2)colonoscopy for standard care of their medical condition. Multiple measurments of Arterial Blood Gass will be performed and evaluated.
Who may be able to join
- All patients (male and female) greater than 18 years of age who undergo a laparoscopic surgical procedure that utilizes intra-operative colonoscopy will be approached to participate in this study
Who cannot join
- Patients under 18 year of age
- Patients with severe Renal Diseases
- Ascites
- COPD (severe)
- Liver insufficiency (severe) with coagulopathy
- Dialysis
Show all 10Show fewer
- Sleep Apnea
- Patient pregnant
- Multiple previous surgeries
- Subject is incapable of understanding the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate prospectively the usefulness of IC-CO2(intraoperative colonoscopy (IC) using carbon dioxide (CO2)) in colon and rectal surgical practice, coincident with laparoscopic surgery, and assess whether it provides useful information that influences the type of surgical therapy intended. Investigators will further define the safety and extent of bowel distension when using IC-CO2.
Read the detailed description
The purpose of this study is to evaluate prospectively the usefulness of IC-CO2(intraoperative colonoscopy (IC) using carbon dioxide (CO2)) in colon and rectal surgical practice, coincident with laparoscopic surgery, and assess whether it provides useful information that influences the type of surgical therapy intended. Investigators will further define the safety and extent of bowel distension when using IC-CO2. Furthermore, the investigators will evaluate the therapy and technique of using this combined approach to the treatment of colorectal polyps and other localized, benign lesions of the large intestine. In this study, the colonoscope is used both as a diagnostic and therapeutic tool, and is often used in order to avoid a major bowel resection, yet effectively treat localized lesions of the large intestine.
The hypothesis of this study is that IC-CO2 will provide useful information which does affect surgical decision making at the time of operation, and that it is safe and does not result in any significant bowel distention during or immediately after the procedure. We additionally hypothesize that certain localized lesions of the intestines may be treated using a combined laparoscopic-IC-CO2 approach to effectively treat the underlying disease, minimize risks to the patient, and avoid a major bowel resection.
- Conditions
- Colorectal Polyps
- Keywords
- laparoscopy, CO2 colonoscopy, intraoperative CO2 colonoscopy, combined Lap-CO2 procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LAP surgery with CO2 colonoscopy | 30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions such as neoplasm or rectal prolapse managed with intra-operative carbon dioxide (co2)colonoscopy for standard care of their medical condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood gas (ABG)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey W Milsom, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725465
- Sponsor's protocol ID
- 0411007608
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2008
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Combined Laparoscopy With CO2 Intraoperative Colonoscopy Treatment for Colorectal Lesions
- ClinicalTrials.gov ID
- NCT00725465
- Acronym / sponsor ID
- 0411007608
- Conditions
- Colorectal Polyps
- Keywords
- laparoscopy, CO2 colonoscopy, intraoperative CO2 colonoscopy, combined Lap-CO2 procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate prospectively the usefulness of IC-CO2(intraoperative colonoscopy (IC) using carbon dioxide (CO2)) in colon and rectal surgical practice, coincident with laparoscopic surgery, and assess whether it provides useful information that influences the type of surgical therapy intended. Investigators will further define the safety and extent of bowel distension when using IC-CO2.
Detailed description
The purpose of this study is to evaluate prospectively the usefulness of IC-CO2(intraoperative colonoscopy (IC) using carbon dioxide (CO2)) in colon and rectal surgical practice, coincident with laparoscopic surgery, and assess whether it provides useful information that influences the type of surgical therapy intended. Investigators will further define the safety and extent of bowel distension when using IC-CO2. Furthermore, the investigators will evaluate the therapy and technique of using this combined approach to the treatment of colorectal polyps and other localized, benign lesions of the large intestine. In this study, the colonoscope is used both as a diagnostic and therapeutic tool, and is often used in order to avoid a major bowel resection, yet effectively treat localized lesions of the large intestine.
The hypothesis of this study is that IC-CO2 will provide useful information which does affect surgical decision making at the time of operation, and that it is safe and does not result in any significant bowel distention during or immediately after the procedure. We additionally hypothesize that certain localized lesions of the intestines may be treated using a combined laparoscopic-IC-CO2 approach to effectively treat the underlying disease, minimize risks to the patient, and avoid a major bowel resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAP surgery with CO2 colonoscopy | – | –30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions such as neoplasm or rectal prolapse managed with intra-operative carbon dioxide (co2)colonoscopy for standard care of their medical condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 surgical patients, male and female undergoing laparoscopic surgical treatment for colorectal conditions such as neoplasm or rectal prolapse managed with intra-operative carbon dioxide (co2)colonoscopy for standard care of their medical condition. Multiple measurments of Arterial Blood Gass will be performed and evaluated.
Key inclusion criteria (1 listed)
- All patients (male and female) greater than 18 years of age who undergo a laparoscopic surgical procedure that utilizes intra-operative colonoscopy will be approached to participate in this study
Key exclusion criteria (10 listed)
- Patients under 18 year of age
- Patients with severe Renal Diseases
- Ascites
- COPD (severe)
- Liver insufficiency (severe) with coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
arterial blood gas (ABG)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- pubmedLink provided by the sponsor.
Related trials for Colorectal Polyps
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey W Milsom, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Polyps, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial blood gas (ABG) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.