Abdominal Adhesions
Conditions
Keywords
abdominal adhesions, diagnostic peritoneoscopy, Natural Orifice Transluminal Endoscopic Surgery, NOTES
Brief summary
The study will document being able to successfully perform transgastric diagnostic peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.
Interventions
DEVICETransgastric diagnostic peritoneoscopy with laparoscopic assistance
Device: Natural Orifice Transgastric Endoscopic (NOTES GEN 1 Toolbox): Articulating Hook Knife(IN2505), Articulating Snare (IN2503), Articulating Needle Knife(IN2504), Articulating Graspers(IN2501 or IN2506), Articulating Biopsy Forceps(IN2502), Steerable Flexible Trocar (IN0501) with Rotary Access Needle (IN0502), Flexible Bipolar Hemostasis Forceps (IN0301), and/or Flexible Maryland Dissector(IN1601)
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Men and women will be enrolled in this study who: * Are willing to give consent and comply with evaluation and treatment schedule; * At least 18 years of age; * Are a candidate for surgical weight loss intervention (i.e. meet ASMBS and NIH criteria) for an RYGB procedure at the Investigational site; * Have a history of open abdominal surgery or laparoscopic abdominal surgery; * ASA Classification I, II, or III (Appendix II); and * Have a negative serum pregnancy test (for women of childbearing potential).
Exclusion criteria
Subjects will be excluded from the study for any of the following: * Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable); * Acute cholecystitis or acute pancreatitis; * Evidence of abdominal abscess or mass; * Diffuse peritonitis; * Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy; * Clinical diagnosis of sepsis; * Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial; * Planned concurrent surgical procedure other than RYGB or adhesiolysis; * Prior or planned major surgical procedure within 30 days before or after study procedure; * Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints; * Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; or * Any condition which precludes compliance with the study (Investigator discretion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Diagnostic Peritineoscopy | Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar | Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome. |
Countries
United States
Participant flow
Recruitment details
Study Initiation Date: 09 June 2009 (First Informed consent signed) Study Completion Date:03 May 2010 (Last subject last visit) Enrollment Location: The Ohio State University Medical Center
Pre-assignment details
All enrolled subjects provided informed consent to participate in the study, met protocol entry criteria, and had the study procedure attempted (ITT population).
Participants by arm
| Arm | Count |
|---|---|
| Natural Orifice Transgastric Diagnostic Peritineoscopy Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Transgastric DP was not completed | 2 |
Baseline characteristics
| Characteristic | Natural Orifice Transgastric Diagnostic Peritineoscopy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age Continuous | 54.2 years STANDARD_DEVIATION 9.76 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Completion of Diagnostic Peritineoscopy
Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome.
Time frame: Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar
Population: The subject pool was limited to individuals scheduled for Rouen Y gastric bypass(Intent to Treat population). There was no statistical analysis. Success was based on completion of the diagnostic peritineoscopy procedure after transgastric access.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Natural Orifice Transgastric Diagnostic Peritineoscopy | Completion of Diagnostic Peritineoscopy | 8 Participants |