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Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery (NOTES)

Primary Purpose

Gastric Foreign Body, Nos, Disorder of Abdomen (Disorder), Foreign Body in Esophagus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Natural Orifice Translumenal Endoscopic Surgery (NOTES)
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Foreign Body, Nos focused on measuring Laparoscopic Surgical Procedures, Endoscopic Surgical Procedures, Laparoscopic & endoscopic procedures with a gastrotomy, or opening in bladder or urethra

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals of Cleveland Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Prospective

Historical

Arm Description

Subjects scheduled to receive procedure

Chart review control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
June 7, 2007
Last Updated
December 12, 2014
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00484783
Brief Title
Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery
Acronym
NOTES
Official Title
Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective
Arm Type
Experimental
Arm Description
Subjects scheduled to receive procedure
Arm Title
Historical
Arm Type
Other
Arm Description
Chart review control group
Intervention Type
Procedure
Intervention Name(s)
Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Other Intervention Name(s)
NOTES Surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Natural Orifice Translumenal Endoscopic Surgery (NOTES)
Other Intervention Name(s)
NOTES Surgery
Intervention Description
chart review of historical data from control group
Primary Outcome Measure Information:
Title
30 day Post-op NOTES feasibility outcomes:
Description
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
Secondary Outcome Measure Information:
Title
30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery
Description
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
Title
30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M. Marks, MD
Organizational Affiliation
University Hospitals of Cleveland/ Institute for Surgical Innovation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Cleveland Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44116
Country
United States

12. IPD Sharing Statement

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Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery

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