ObesityNCT00610025
Minimally Invasive Trocar Placement in Obesity Surgery
A study testing Transgastric access to the abdomen in people with Obesity, run by Jeffrey Hazey at 1 site in United States.
Trial summary
During surgery for obesity, minimally invasive endoscopy can be performed and can assist the surgeon in determining surgical incision sites. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Transgastric access to the abdomen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Nov 2009
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery
Who cannot join
- Lack of consent
- History of previous gastric surgery
- Contraindication to upper endoscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center/Center for Minimally Invasive Surgery
Columbus, Ohio, 43210
About this study
Official title: Transgastric Peritoneoscopy for Evaluation of the Abdominal Wall to Direct Laparoscopic Trocar Placement
During surgery for obesity, minimally invasive endoscopy can be performed and can assist the surgeon in determining surgical incision sites.
Read the detailed description
Transgastric endoscopic access, without laparoscopic guidance, to the peritoneal cavity can be performed safely and guide trocar placement in morbidly obese patients undergoing Roux-en-y gastric bypass.
- Conditions
- Obesity
- Being tested
- Transgastric access to the abdomen
- Keywords
- NOTES, transgastric endoscopy, obesity surgery, Roux-en-Y surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transgastric access to the abdomenProcedure or surgery
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 10 patients with no previous abdominal surgeries, pre-insufflation of the abdomen using a veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery) Receives: Procedure: Transgastric access to the abdomen |
| 2 | Active comparator | 10 patients with history of previous abdominal surgeries, pre-insufflation of the abdomen using veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery) Receives: Procedure: Transgastric access to the abdomen |
| 3 | Active comparator | 10 patients with no previous history of abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) Receives: Procedure: Transgastric access to the abdomen |
| 4 | Active comparator | 10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) Receives: Procedure: Transgastric access to the abdomen |
| 5 | Active comparator | 10 patients, all with no previous mid to upper abdominal surgeries, no Veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) Receives: Procedure: Transgastric access to the abdomen |
| 6 | Active comparator | 10 patients, all with previous mid-to-upper abdominal surgeries, no Veress needle pre-insufflation, endoscopic take-down of intra-abdominal adhesions (if identified) Receives: Procedure: Transgastric access to the abdomen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The achievement of safe transgastric access to the abdomen; the ability to visualize the abdominal wall to assist in safe trocar placement in the morbidly obese patient.
Measured: At surgery
Secondary outcomes (1)
Bacterial contamination analysis; results compared to previous study.
Measured: Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Hazey
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker SA, Natural Orifice Surgery Consortium for Assessment and Research
- Responsible party
- Sponsor-investigator, Jeffrey Hazey, Ohio State University
- Investigators
- Jeffrey W Hazey, MD, Principal investigator, The Ohio State University Medical Center/Center for Minimally Invasive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610025
- Sponsor's protocol ID
- NOTES Trocar Study
- Other IDs
- Project 60009927, Award GRT00006515, IRB 2007H0045
- Status last verified
- Feb 2013
- First submitted
- 26 Dec 2007
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transgastric Peritoneoscopy for Evaluation of the Abdominal Wall to Direct Laparoscopic Trocar Placement
- ClinicalTrials.gov ID
- NCT00610025
- Acronym / sponsor ID
- NOTES Trocar Study
- Conditions
- Obesity
- Keywords
- NOTES, transgastric endoscopy, obesity surgery, Roux-en-Y surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jeffrey HazeyUniversity, hospital or other
- Collaborators
- Stryker SA, Natural Orifice Surgery Consortium for Assessment and Research
- Study start
- Jul 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 Feb 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.
During surgery for obesity, minimally invasive endoscopy can be performed and can assist the surgeon in determining surgical incision sites.
Detailed description
Transgastric endoscopic access, without laparoscopic guidance, to the peritoneal cavity can be performed safely and guide trocar placement in morbidly obese patients undergoing Roux-en-y gastric bypass.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Transgastric access to the abdomen10 patients with no previous abdominal surgeries, pre-insufflation of the abdomen using a veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery) |
| 2 | Active comparator | Procedure: Transgastric access to the abdomen10 patients with history of previous abdominal surgeries, pre-insufflation of the abdomen using veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery) |
| 3 | Active comparator | Procedure: Transgastric access to the abdomen10 patients with no previous history of abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) |
| 4 | Active comparator | Procedure: Transgastric access to the abdomen10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) |
| 5 | Active comparator | Procedure: Transgastric access to the abdomen10 patients, all with no previous mid to upper abdominal surgeries, no Veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically) |
| 6 | Active comparator | Procedure: Transgastric access to the abdomen10 patients, all with previous mid-to-upper abdominal surgeries, no Veress needle pre-insufflation, endoscopic take-down of intra-abdominal adhesions (if identified) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery
Key exclusion criteria (3 listed)
- Lack of consent
- History of previous gastric surgery
- Contraindication to upper endoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transgastric access to the abdomenUpper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy. | Procedure or surgery | 1, 2, 3, 4, 5, 6 |
Primary outcome
The achievement of safe transgastric access to the abdomen; the ability to visualize the abdominal wall to assist in safe trocar placement in the morbidly obese patient.
Time frame: At surgery
1 secondary outcome
Bacterial contamination analysis; results compared to previous study.
Time frame: Surgery
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 12 Feb 2013.
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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 W Hazey, MD principal investigator
The Ohio State University Medical Center/Center for Minimally Invasive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transgastric access to the abdomen in people with Obesity, run by Jeffrey Hazey 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 3 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 12 Feb 2013. 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?
The achievement of safe transgastric access to the abdomen; the ability to visualize the abdominal wall to assist in safe trocar placement in the morbidly obese patient. (time frame: At surgery). 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 12 Feb 2013.