An interventional study of Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Natural Orifice Translumenal Endoscopic Surgery (NOTES) in Gastric Foreign Body, Nos, Disorder of Abdomen (Disorder) and Foreign Body in Esophagus, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-12-16.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
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.
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.
84 studies on the registry are indexed under Prostatic Diseases; 19 are open to participants now.
This study's enrollment of 11 is below the median of 77 across 66 interventional studies indexed under Prostatic Diseases.
Browse Prostatic Diseases studies →University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects scheduled to receive procedure
Procedure: Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Chart review control group
Procedure: Natural Orifice Translumenal Endoscopic Surgery (NOTES)
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.
Also known as: NOTES Surgery
chart review of historical data from control group
Also known as: NOTES Surgery
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
Time frame: 30 days post-op
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
Time frame: 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
Time frame: 30 Day Post - Op
The record gives a start of Aug 2006, a primary completion of Jan 2009 and a completion of Jan 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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