Gastric Foreign Body, NosNOTESNCT00484783
Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery
A study testing Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Natural Orifice Translumenal Endoscopic Surgery (NOTES) in people with Gastric Foreign Body, Nos and Disorder of Abdomen (Disorder), run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
NOTES access is safe and feasible in the controlled human setting and comparable to standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate visualization comparable to laparoscopy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Foreign Body, Nos, Disorder of Abdomen (Disorder), Foreign Body in Esophagus
- What is being tested?
- Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Natural Orifice Translumenal Endoscopic Surgery (NOTES)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing an already combined laparoscopic and endoscopic foregut procedure with general anesthesia
- Patients undergoing a prostatectomy or cystectomy with general anesthesia
- All patients will have a planned gastrotomy for exploration, foreign body removal, or removal of tissue, making it a contaminated case or a planned cystotomy or urethrotomy for exploration, foreign body removal or removal of tissue such as prostatectomy or bladder resection.
- No overwhelming medical co-morbidities
- Subject is 18 years of age or older
- Subject is his or her own medical decision maker
- Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form
Who cannot join
- Patients undergoing a non-palliative procedure in the face of resectable adenocarcinoma of the foregut or genitourinary tract
- Linitis Plastica
- Evidence of Active Bowel Obstruction
- Patients with history of oropharyngeal, esophageal, or gastric adenocarcinoma.
- Esophageal stricture prohibiting passage of an endoscope
- Urethral stricture prohibiting passage of an endoscope
Show all 12Show fewer
- Emergent Surgery
- At any time during pre-operative or intra-operative periods, evidence of unresectability is demonstrated
- Any intra-operative condition prior to surgical resection that results in abortion of the surgical procedure
- Any contraindication to surgery
- Pregnancy or actively breastfeeding women
- Prisoners or Wards of State
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, 44116
About this study
Official title: Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery
NOTES access is safe and feasible in the controlled human setting and comparable to standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate visualization comparable to laparoscopy.
Read the detailed description
This is a prospective clinical trial to evaluate the feasibility of obtaining peritoneal cavity access from natural orifice translumenal endoscopic surgery (NOTES) during combined laparoscopic-endoscopic foregut surgery. Post-operative course will be compared with a historical chart-review control group of patients undergoing standard laparoscopic foregut and urologic surgery.
The study group will be compiled by open enrollment for male and female adult subjects scheduled for combined laparoscopic-endoscopic surgery of the stomach, abdominal esophagus, prostate, bladder, proximal small intestine or who meet inclusion and exclusion criteria. The historical chart-review control group will be randomly chosen from patients from 2003-2006 having undergone combined laparoscopic-endoscopic surgery of the foregut, prostate, or bladder and as determined by CPT coding.
The purpose of the study is to determine if NOTES access and abdominal exploration is feasible, safe, offers comparable visualization to laparoscopy in a controlled human setting.
- Conditions
- Gastric Foreign Body, Nos, Disorder of Abdomen (Disorder), Foreign Body in Esophagus, Prostatic Diseases, Disease of Small Intestine
- Being tested
- Natural Orifice Transluminal Endoscopic Surgery (NOTES), Natural Orifice Translumenal Endoscopic Surgery (NOTES)
- Keywords
- Laparoscopic Surgical Procedures, Endoscopic Surgical Procedures, Laparoscopic & endoscopic procedures with a gastrotomy, or opening in bladder or urethra
- Medical subject headings
- Pyloric Stenosis, Hypertrophic, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Orifice Transluminal Endoscopic Surgery (NOTES)Procedure or surgery
Also called NOTES Surgery
Patients will have the standard laparoscopic procedure and the NOTES procedure will be added. The surgical procedure will require two operating teams: one led by a laparoscopic surgeon, the other by an endoscopic surgeon. During the usual course of the surgery, the flexible endoscope will be passed through the mouth urethra top gain access to the peritoneal cavity.
Natural Orifice Translumenal Endoscopic Surgery (NOTES)Procedure or surgery
Also called NOTES Surgery
chart review of historical data from control group
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Experimental | Subjects scheduled to receive procedure Receives: Procedure: Natural Orifice Transluminal Endoscopic Surgery (NOTES) |
| Historical | Other | Chart review control group Receives: Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day Post-op NOTES feasibility outcomes:
- Number of successful NOTES access attempts
- Number of failed NOTES access attempts
- Injury to collateral organs or structures
- Time to gain access to peritoneal cavity
- Necessary balloon dilator size required for translumenal passage of endoscope
Measured: 30 days post-op
Secondary outcomes (2)
30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery
Description: Mortality Post-Op Mobidity repeat sugery Intra-Op or Post-Op RBC Transfusion Intra-Abdominal Abscess Superficial Surgical Site Infection Antibiotics>24th Post-Op
Safety Issue?: Yes
Measured: 30 Day Post-OP
30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration
Description: Identification of Specified Abdominal and Pelvic Organs Time to Adequately Visualize Specified Abdominal and Pelvic Organs Comparitive findings between standardaized abdominal exploration between laparoscopy and NOTES techniques
Measured: 30 Day Post - Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startAug 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Foreign Body, NosStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 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 of Cleveland/ Institute for Surgical Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484783
- Sponsor's protocol ID
- 08-06-13
- Acronym
- NOTES
- Status last verified
- Dec 2014
- First submitted
- 7 Jun 2007
- 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
- Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery
- ClinicalTrials.gov ID
- NCT00484783
- Acronym / sponsor ID
- NOTES / 08-06-13
- Conditions
- Gastric Foreign Body, Nos, Disorder of Abdomen (Disorder), Foreign Body in Esophagus, Prostatic Diseases, Disease of Small Intestine
- Keywords
- Laparoscopic Surgical Procedures, Endoscopic Surgical Procedures, Laparoscopic & endoscopic procedures with a gastrotomy, or opening in bladder or urethra
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 11 Jun 2007 (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.
NOTES access is safe and feasible in the controlled human setting and comparable to standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate visualization comparable to laparoscopy.
Detailed description
This is a prospective clinical trial to evaluate the feasibility of obtaining peritoneal cavity access from natural orifice translumenal endoscopic surgery (NOTES) during combined laparoscopic-endoscopic foregut surgery. Post-operative course will be compared with a historical chart-review control group of patients undergoing standard laparoscopic foregut and urologic surgery.
The study group will be compiled by open enrollment for male and female adult subjects scheduled for combined laparoscopic-endoscopic surgery of the stomach, abdominal esophagus, prostate, bladder, proximal small intestine or who meet inclusion and exclusion criteria. The historical chart-review control group will be randomly chosen from patients from 2003-2006 having undergone combined laparoscopic-endoscopic surgery of the foregut, prostate, or bladder and as determined by CPT coding.
The purpose of the study is to determine if NOTES access and abdominal exploration is feasible, safe, offers comparable visualization to laparoscopy in a controlled human setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | Experimental | Procedure: Natural Orifice Transluminal Endoscopic Surgery (NOTES)Subjects scheduled to receive procedure |
| Historical | Other | Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES)Chart review control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients undergoing an already combined laparoscopic and endoscopic foregut procedure with general anesthesia
- Patients undergoing a prostatectomy or cystectomy with general anesthesia
- All patients will have a planned gastrotomy for exploration, foreign body removal, or removal of tissue, making it a contaminated case or a planned cystotomy or urethrotomy for exploration, foreign body removal or removal of tissue such as prostatectomy or bladder resection.
- No overwhelming medical co-morbidities
- Subject is 18 years of age or older
Key exclusion criteria (12 listed)
- Patients undergoing a non-palliative procedure in the face of resectable adenocarcinoma of the foregut or genitourinary tract
- Linitis Plastica
- Evidence of Active Bowel Obstruction
- Patients with history of oropharyngeal, esophageal, or gastric adenocarcinoma.
- Esophageal stricture prohibiting passage of an endoscope
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 |
|---|---|---|
| Natural Orifice Transluminal Endoscopic Surgery (NOTES)Also: NOTES SurgeryPatients will have the standard laparoscopic procedure and the NOTES procedure will be added. The surgical procedure will require two operating teams: one led by a laparoscopic surgeon, the other by an endoscopic surgeon. During the usual course of the surgery, the flexible endoscope will be passed through the mouth urethra top gain access to the peritoneal cavity. | Procedure or surgery | Prospective |
| Natural Orifice Translumenal Endoscopic Surgery (NOTES)Also: NOTES Surgerychart review of historical data from control group | Procedure or surgery | Historical |
Primary outcome
30 day Post-op NOTES feasibility outcomes:
Time frame: 30 days post-op
* Number of successful NOTES access attempts * Number of failed NOTES access attempts * Injury to collateral organs or structures * Time to gain access to peritoneal cavity * Necessary balloon dilator size required for translumenal passage of endoscope
2 secondary outcomes
30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery
Time frame: 30 Day Post-OP
30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration
Time frame: 30 Day Post - Op
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.
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 of Cleveland/ Institute for Surgical Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Natural Orifice Translumenal Endoscopic Surgery (NOTES) in people with Gastric Foreign Body, Nos and Disorder of Abdomen (Disorder), 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 7 inclusion and 12 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.
What does the primary outcome measure?
30 day Post-op NOTES feasibility outcomes: (time frame: 30 days post-op). 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 16 Dec 2014.