Colonic DiseasesNOTESNCT01102725
Assessing Infectious Risk and Visceral Closure in Natural Orifice Translumenal Endoscopic Surgery (NOTES)
An observational study of Colonic Diseases and Rectal Diseases, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine: 1. What quantity of bacteria is spilled into the abdomen during a colon resection 2. If there is a correlation between the quantity and post-operative infection 3. What intralumenal pressure is generated when testing the colonic anastomosis for air leak Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Diseases, Rectal Diseases
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Our institution performed over 200 laparoscopic colon resections in the past year and should have no trouble accruing the number of patients required for the study. Subjects will be recruited until 90 patients have been enrolled. We will not specifically recruit or specifically exclude potential patients on the basis of their race or on the basis of our study demographics to date. No vulnerable subjects will be recruited into this study as this study will prolong the surgery by approximately 15 minutes which can be significant in the vulnerable population such as pregnant women and minors. Potential subjects who meet inclusion criteria will be approached for possible participation during a pre-operative clinic visit or on the day of surgery in the pre-operative area.
Who may be able to join
- Male and Female patients ≥18 years of age
- Subjects have a known preexisting condition that has been deemed treatable by totally laparoscopic or hand-assisted laparoscopic colorectal resection
- Any colon or rectal resection where ileocolonic, ileorectal, colocolonic, or colorectal anastomoses is created in the pelvis requiring a leak test. Air-leak test can be performed by an instrument of the surgeons discretion, such as a colonoscope, sigmoidoscope (rigid or flexible), or bulb syringe.
Who cannot join
- Surgical resection performed in an emergency setting
- Patients undergoing resection in a known contaminated field (i.e. entero-/colo-cutaneous fistula or acute diverticulitis) as this will bias the bacterial cultures collected intraoperatively
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: The Challenge of Assessing Infectious Risk and Visceral Closure in NOTES: A Prospective Study Examining Routine Colorectal Surgery as a Model in Humans
The purpose of this study is to determine:
- What quantity of bacteria is spilled into the abdomen during a colon resection
- If there is a correlation between the quantity and post-operative infection
- What intralumenal pressure is generated when testing the colonic anastomosis for air leak
Read the detailed description
The acceptance and advancement of natural orifice translumenal endoscopic surgery (NOTES) has forced investigators to challenge many firmly accepted surgical practices. The most obvious one being: violating a remote hollow viscous that is uninvolved in the desired surgical intervention. This of course brings into question (1) "How much peritoneal contamination can be tolerated without raising infection risk?" and (2) "How will one repair this intended visceral injury?" This study is intended to bring to light what has been done in animal models, and further, how it will translate in to the now more important human arena.
In this study, patients who are undergoing an elective colectomy will be investigated to quantify what amount of peritoneal contamination is tolerated despite rare abscess formation occurring. Subject will undergo peritoneal washings before and after colonic resection to measure the bacterial load spilled. This data would be beneficial to support that patients who are undergoing a NOTES procedure can and will be able to tolerate a definite quantity of bacterial contaminate. Furthermore, by observing the exact values of peritoneal contamination present there may be a certain level to which infectious complication are more likely to occur. This may provide some insight in NOTES as to when patients may benefit post-operatively from a prophylactic course of antibiotic therapy in response to their higher than tolerable intra-peritoneal bacterial load.
The other component to this study will be to challenge how investigators are examining closure devices in the animal model. Many researchers, including authors of this protocol, have utilized bursting pressure as an objective test to assess the integrity of a completed closure. Current surgical practice uses the insufflation of an endoscope or even a bulb syringe to test for leak of a colonic anastomosis. We intend to measure the pressures that are achieved in a clinical setting to determine the bursting pressures that are required to assess NOTES closure and eliminate the likely unsupported value being placed on a higher bursting pressure commonly quoted in NOTES closure studies.
- Conditions
- Colonic Diseases, Rectal Diseases
- Keywords
- Colon Surgery, Rectal Surgery, Colorectal Surgery
- Medical subject headings
- Colonic Diseases, Rectal Diseases
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 |
|---|---|---|
| Colorectal Surgery | Subject who are undergoing a colon or rectal resection |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Marks, MD, University Hospitals Cleveland Medical Center
- Investigators
- Jeffrey M. Marks, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102725
- Sponsor's protocol ID
- 02-09-39
- Other IDs
- 02-09-39
- Acronym
- NOTES
- Status last verified
- Dec 2014
- First submitted
- 12 Apr 2010
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Challenge of Assessing Infectious Risk and Visceral Closure in NOTES: A Prospective Study Examining Routine Colorectal Surgery as a Model in Humans
- ClinicalTrials.gov ID
- NCT01102725
- Acronym / sponsor ID
- NOTES / 02-09-39
- Conditions
- Colonic Diseases, Rectal Diseases
- Keywords
- Colon Surgery, Rectal Surgery, Colorectal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Apr 2010 (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 determine:
- What quantity of bacteria is spilled into the abdomen during a colon resection
- If there is a correlation between the quantity and post-operative infection
- What intralumenal pressure is generated when testing the colonic anastomosis for air leak
Detailed description
The acceptance and advancement of natural orifice translumenal endoscopic surgery (NOTES) has forced investigators to challenge many firmly accepted surgical practices. The most obvious one being: violating a remote hollow viscous that is uninvolved in the desired surgical intervention. This of course brings into question (1) "How much peritoneal contamination can be tolerated without raising infection risk?" and (2) "How will one repair this intended visceral injury?" This study is intended to bring to light what has been done in animal models, and further, how it will translate in to the now more important human arena.
In this study, patients who are undergoing an elective colectomy will be investigated to quantify what amount of peritoneal contamination is tolerated despite rare abscess formation occurring. Subject will undergo peritoneal washings before and after colonic resection to measure the bacterial load spilled. This data would be beneficial to support that patients who are undergoing a NOTES procedure can and will be able to tolerate a definite quantity of bacterial contaminate. Furthermore, by observing the exact values of peritoneal contamination present there may be a certain level to which infectious complication are more likely to occur. This may provide some insight in NOTES as to when patients may benefit post-operatively from a prophylactic course of antibiotic therapy in response to their higher than tolerable intra-peritoneal bacterial load.
The other component to this study will be to challenge how investigators are examining closure devices in the animal model. Many researchers, including authors of this protocol, have utilized bursting pressure as an objective test to assess the integrity of a completed closure. Current surgical practice uses the insufflation of an endoscope or even a bulb syringe to test for leak of a colonic anastomosis. We intend to measure the pressures that are achieved in a clinical setting to determine the bursting pressures that are required to assess NOTES closure and eliminate the likely unsupported value being placed on a higher bursting pressure commonly quoted in NOTES closure studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Surgery | – | –Subject who are undergoing a colon or rectal resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Our institution performed over 200 laparoscopic colon resections in the past year and should have no trouble accruing the number of patients required for the study. Subjects will be recruited until 90 patients have been enrolled. We will not specifically recruit or specifically exclude potential patients on the basis of their race or on the basis of our study demographics to date. No vulnerable subjects will be recruited into this study as this study will prolong the surgery by approximately 15 minutes which can be significant in the vulnerable population such as pregnant women and minors. Potential subjects who meet inclusion criteria will be approached for possible participation during a pre-operative clinic visit or on the day of surgery in the pre-operative area.
Key inclusion criteria (3 listed)
- Male and Female patients ≥18 years of age
- Subjects have a known preexisting condition that has been deemed treatable by totally laparoscopic or hand-assisted laparoscopic colorectal resection
- Any colon or rectal resection where ileocolonic, ileorectal, colocolonic, or colorectal anastomoses is created in the pelvis requiring a leak test. Air-leak test can be performed by an instrument of the surgeons discretion, such as a colonoscope, sigmoidoscope (rigid or flexible), or bulb syringe.
Key exclusion criteria (2 listed)
- Surgical resection performed in an emergency setting
- Patients undergoing resection in a known contaminated field (i.e. entero-/colo-cutaneous fistula or acute diverticulitis) as this will bias the bacterial cultures collected intraoperatively
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
Not reported in the source record.
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 16 Dec 2014.
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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 M. Marks, MD principal investigator
University Hospitals Cleveland Medical Center
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 Colonic Diseases and Rectal Diseases, run by University Hospitals Cleveland Medical Center 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 3 inclusion and 2 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 16 Dec 2014. 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.
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 16 Dec 2014.