Disease of Small Intestine, Disorder of Abdomen (Disorder), Foreign Body in Esophagus, Gastric Foreign Body, Nos, Prostatic Diseases
Conditions
Keywords
Laparoscopic Surgical Procedures, Endoscopic Surgical Procedures, Laparoscopic & endoscopic procedures with a gastrotomy, or opening in bladder or urethra
Brief 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.
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.
Interventions
PROCEDURENatural Orifice Transluminal 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.
PROCEDURENatural Orifice Translumenal Endoscopic Surgery (NOTES)
chart review of historical data from control group
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 day Post-op NOTES feasibility outcomes: | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery | 30 Day Post-OP | 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 |
| 30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration | 30 Day Post - Op | 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 |
Countries
United States
Outcome results
None listed