MalnutritionPEGRescueNCT01119040
Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue"
A study testing Natural Orifice Translumenal Endoscopic Surgery in people with Malnutrition, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine: 1. Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube. 2. Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods. 3. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Natural Orifice Translumenal Endoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Patients must meet ALL of the following criteria
- For prospective candidates, an initial attempt to pass a balloon tipped foley catheter through the external cutaneous tract into the stomach will be performed. It will then be followed by radiographic contrast study to evaluate for extravasation of contrast into the peritoneal cavity. If contrast is extravasated, this will be potential candidate for inclusion. If the foley catheter is unable to be passed through the cutaneous tract, that will also be considered someone for inclusion as this patient will still require an operative confirmation of the patency of the gastrotomy.
- For retrospective candidates, intra-operative confirmation of dislodged tube as reported in the medical record.
- The patient must demonstrate pre-operative hemodynamic and respiratory stability
- No overwhelming medical co-morbidities prohibitive of surgery
- Subject is 18 years of age or older
- Subject or subject's legal decision-making proxy agrees to participate, fully understands and signs the informed consent form
Exclusion Criteria: Patients must not meet ANY of the following criteria:
- Esophageal stricture prohibiting passage of an endoscope
- Any contraindication to surgery
- Pregnancy or actively breastfeeding women
- Evidence of active bowel obstruction
- Synchronous acute abdominal pathology warranting incision-based surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Prospective Evaluation of NOTES PEG "Rescue"
The purpose of this study is to determine:
- Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube.
- Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods.
- Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.
Read the detailed description
- Utility of Urgent Upper Endoscopy in Setting of Naïve Dislodged PEG Tubes as defined by:
- Percentage of Open vs. Closed Gastrotomy upon urgent endoscopy
- Presence of Incidental Pathology noted on Endoscopy
- Complications of Urgent Endoscopy
- Time of Procedure
- Technical Feasibility of the NOTES procedure determined by:
- Number of Successful/Failed PEG Placements
- Number of Patients Requiring intra-operative conversion to laparotomy or laparoscopic procedure
- Time to Complete Procedure
- Presence or absence of post-procedural contrast extravasation on completion contrast radiographic study
- Efficacy of NOTES PEG Rescue compared to historical controls as characterized by the following post-operative criteria:
- Number of Patients Requiring Subsequent Medical or Surgical Treatment for Intra-Abdominal Abscess
- Number of Patients Requiring Subsequent Medical or Surgical Wound Infection within 30 post-op days
- Post-Operative CT or Operative Findings consistent with abscess confirmed by culture positive drainage, aspiration
- Intra-Operative or Post-Operative Red Blood Cell Transfusion
- Length of Stay
- Antibiotics > 24h Post-Op
- 30 day Re-Admission
- Mortality
- Conditions
- Malnutrition
- Being tested
- Natural Orifice Translumenal Endoscopic Surgery
- Keywords
- Dislodged PEG tube, NOTES
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Orifice Translumenal Endoscopic SurgeryProcedure or surgery
Also called NOTES
Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions. No clear indication due to a number of physiologic, microbiologic, immunologic, and technical limitations. The concept of NOTES PEG "Rescue" in the setting of a dislodged naïve PEG tube may spare individual patients the physiologic stress of traditional surgery while concomitantly providing a natural segue to further study the NOTES platform in the human setting. PEG "Rescue" may represent a unique, practical, and empowering application of the burgeoning experience of natural orifice translumenal endoscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| NOTES PEG Rescue | Experimental | A new way of performing surgery is called Natural Orifice Translumenal Endoscopic Surgery, or NOTES, for short. NOTES may allow surgeons to perform abdominal surgery without any skin incisions. By using natural openings in the body, like the mouth, surgeons can enter the stomach with a tube instead of the traditional method of making an incision in the skin of the abdomen. Receives: Procedure: Natural Orifice Translumenal Endoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.
Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.
Measured: 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startNov 2007
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 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 Marks, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119040
- Sponsor's protocol ID
- 09-07-23
- Acronym
- PEGRescue
- Status last verified
- Dec 2014
- First submitted
- 6 May 2010
- Last updated
- 5 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Marks JM, Ponsky JL, Pearl JP, McGee MF. PEG "Rescue": a practical NOTES technique. Surg Endosc. 2007 May;21(5):816-9. doi: 10.1007/s00464-007-9361-2. Epub 2007 Apr 3.
PubMed 17404790
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of NOTES PEG "Rescue"
- ClinicalTrials.gov ID
- NCT01119040
- Acronym / sponsor ID
- PEGRescue / 09-07-23
- Conditions
- Malnutrition
- Keywords
- Dislodged PEG tube, NOTES
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 May 2010 (estimated)
- Results
- Posted 3 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine:
- Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube.
- Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods.
- Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.
Detailed description
- Utility of Urgent Upper Endoscopy in Setting of Naïve Dislodged PEG Tubes as defined by:
- Percentage of Open vs. Closed Gastrotomy upon urgent endoscopy
- Presence of Incidental Pathology noted on Endoscopy
- Complications of Urgent Endoscopy
- Time of Procedure
- Technical Feasibility of the NOTES procedure determined by:
- Number of Successful/Failed PEG Placements
- Number of Patients Requiring intra-operative conversion to laparotomy or laparoscopic procedure
- Time to Complete Procedure
- Presence or absence of post-procedural contrast extravasation on completion contrast radiographic study
- Efficacy of NOTES PEG Rescue compared to historical controls as characterized by the following post-operative criteria:
- Number of Patients Requiring Subsequent Medical or Surgical Treatment for Intra-Abdominal Abscess
- Number of Patients Requiring Subsequent Medical or Surgical Wound Infection within 30 post-op days
- Post-Operative CT or Operative Findings consistent with abscess confirmed by culture positive drainage, aspiration
- Intra-Operative or Post-Operative Red Blood Cell Transfusion
- Length of Stay
- Antibiotics > 24h Post-Op
- 30 day Re-Admission
- Mortality
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOTES PEG Rescue | Experimental | Procedure: Natural Orifice Translumenal Endoscopic SurgeryA new way of performing surgery is called Natural Orifice Translumenal Endoscopic Surgery, or NOTES, for short. NOTES may allow surgeons to perform abdominal surgery without any skin incisions. By using natural openings in the body, like the mouth, surgeons can enter the stomach with a tube instead of the traditional method of making an incision in the skin of the abdomen. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 Translumenal Endoscopic SurgeryAlso: NOTESNatural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions. No clear indication due to a number of physiologic, microbiologic, immunologic, and technical limitations. The concept of NOTES PEG "Rescue" in the setting of a dislodged naïve PEG tube may spare individual patients the physiologic stress of traditional surgery while concomitantly providing a natural segue to further study the NOTES platform in the human setting. PEG "Rescue" may represent a unique, practical, and empowering application of the burgeoning experience of natural orifice translumenal endoscopic surgery. | Procedure or surgery | NOTES PEG Rescue |
Primary outcome
Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.
Time frame: 30 day follow-up
Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17404790Marks JM, Ponsky JL, Pearl JP, McGee MF. PEG "Rescue": a practical NOTES technique. Surg Endosc. 2007 May;21(5):816-9. doi: 10.1007/s00464-007-9361-2. Epub 2007 Apr 3.
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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 Marks, MD principal investigator
University Hospitals Cleveland Medical Center
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 Translumenal Endoscopic Surgery in people with Malnutrition, 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?
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: stopped early, as of the sponsor's last update on 5 Jan 2015. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods. (time frame: 30 day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01119040, which also lists 1 linked publication.
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 5 Jan 2015.