(NOTES)TM for Intra-abdominal Surgery ASERNIP S

142 Pages·2007·0.73 MB·English

ASERNIP S

Australian Safety
and Efficacy
Register of New
Interventional
Procedures - Surgical
Systematic Review
Natural Orifice Translumenal
Endoscopic Surgery (NOTES)TM for
Intra-abdominal Surgery
ASERNIP-S REPORT NO. 62

Australian Safety & Efficacy Register of
New Interventional Procedures – Surgical
The Royal Australasian College of Surgeons

- ASERNIP-S REVIEW OF NATURAL ORIFICE TRANSLUMENAL ENDOSCOPIC SURGERY (NOTES)TM FOR INTRA-
ABDOMINAL SURGERY – JULY 2007 -
A Systematic Review of Natural Orifice Translumenal
Endoscopic Surgery (NOTES)TM for Intra-Abdominal Surgery

ISBN 0909844 84 4
Published July 2007

This report should be cited in the following manner:
Della Flora E, et al. A Systematic Review of Natural Orifice Translumenal
Endoscopic Surgery (NOTES)TM for Intra-abdominal Surgery. ASERNIP-S Report
No. 62. Adelaide, South Australia: ASERNIP-S, July 2007.

Copies of these reports can be obtained from:
ASERNIP-S
PO Box 553,
Stepney, SA 5069
AUSTRALIA
Ph: 61-8-8363 7513
Fax: [phone]
E-Mail: [email protected]
http://www.surgeons.org/asernip-s
- ASERNIP-S REVIEW OF NATURAL ORIFICE TRANSLUMENAL ENDOSCOPIC SURGERY (NOTES)TM FOR INTRA-
ABDOMINAL SURGERY – JULY 2007 -

The Safety and Efficacy Classification for the

Systematic Review of Natural Orifice Translumenal Endoscopic

Surgery (NOTES)TM for Intra-Abdominal Surgery

was ratified by:

The ASERNIP-S Management Committee on

June 2007

and

The Council of the Royal Australasian College of Surgeons on

July 2007
- ASERNIP-S REVIEW OF NATURAL ORIFICE TRANSLUMENAL ENDOSCOPIC SURGERY (NOTES)TM FOR INTRA-
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Table of Contents

Executive Summary........................................................................iv
The ASERNIP-S Classification System ........................................vii
The ASERNIP-S Review Group.....................................................ix
Introduction.....................................................................................1
Objective..........................................................................................................1
Intra-abdominal Surgery................................................................................1
Conditions treatable by intra-abdominal surgery..................................1
Burden of disease in Australia.................................................................2
Comparative treatments...........................................................................3
Open abdominal surgery/laparotomy....................................................3
Minimally invasive surgery.......................................................................4
New interventional Procedure......................................................................6
Natural Orifice Transluminal Endoscopic Surgery..............................6
Summary..........................................................................................................7
Research questions.........................................................................................8
Methods...........................................................................................9
Literature search protocol.............................................................................9
Inclusion criteria........................................................................................9
Literature search strategies..........................................................................10
Search terms.............................................................................................11
Literature database & exclusions...........................................................12
Data extraction and assessment of study quality.....................................12
Data analysis..................................................................................................12
Studies Included in the Review......................................................13
Literature Search Results.............................................................................13
Ongoing and unpublished trials.................................................................13
SAGES 2006 and 2007 Meeting Abstracts...............................................13
Description of studies..................................................................................15
Results............................................................................................20
Efficacy...........................................................................................................20
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- ASERNIP-S REVIEW OF NATURAL ORIFICE TRANSLUMENAL ENDOSCOPIC SURGERY (NOTES)TM FOR INTRA-
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Success of surgical techniques...............................................................20
Success of NOTES intervention and techniques...............................31
Duration of surgery.................................................................................37
Safety...............................................................................................................39
Post-operative mortality..........................................................................39
Post-operative recovery..........................................................................40
Infection-related complications.............................................................40
Procedure-Related Complications.........................................................42
Discussion ......................................................................................44
Conclusions....................................................................................53
Classification and Recommendations........................................................53
Classifications...........................................................................................53
Clinical and Research Recommendations............................................53
Acknowledgments.........................................................................................54
References ......................................................................................55
Appendix A – Hierarchy Of Evidence......................................................66
Appendix B – Conference proceedings ....................................................69
SAGES 2006 Presentations....................................................................69
SAGES 2007 presentations....................................................................70
Appendix C – Excluded Studies.................................................................75
Appendix D – Glossary...............................................................................77
Appendix E – Equipment descriptions.....................................................79
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List of Tables

Table 1. Summary of included studies..............................................................................16
Table 2: Summary of subjects.............................................................................................19
Table 3: Sites chosen for NOTES viscerotomy..............................................................21
Table 4: NOTES gastrotomy closure................................................................................24
Table 5: Success of visualisation using NOTES..............................................................27
Table 6: Success of NOTES anastomosis creation.........................................................32
Table 7: Success of NOTES cholecystectomy.................................................................33
Table 8: Success of NOTES biopsy..................................................................................34
Table 9: Duration of Surgery..............................................................................................38
Table 10: Post-operative mortality.....................................................................................39
Table 11: Post-operative feeding and weight gain...........................................................40
Table 12: Infection-related complications........................................................................41
SAGES 2006 Abstracts.......................................................................................................69
Excluded Studies..................................................................................................................75

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Executive Summary

Objective
To assess the safety and efficacy of various intra-abdominal Natural Orifice
Translumenal* Endoscopic SurgeryTM (NOTESTM) procedures which do not cut the
dermis, in comparison with traditional intra-abdominal surgery which cuts the
dermis, through a systematic review of the literature.
Methods
Search strategy – Studies were identified by performing electronic searches of
MEDLINE, EMBASE, CINAHL, Current Contents, the Cochrane Library and
Entrez-PubMed from 2000 to March 2007. The clinical trials database (US), NHS
CRD databases and National Research Register (UK) were also searched in March
2007 and the SAGES 2006 and 2007 annual meeting abstracts for were sourced for
information.
Study selection – Studies conducted in live humans or animals involving surgical
procedures in the intra-abdominal region using natural orifice access were included
for review; however studies in cadavers were excluded. Studies where the new
intervention involved an incision to the dermis were excluded and studies reporting
established endoscopic procedures that are not transluminal such as abscess or cyst
drainage or debridement were not included as they are standard practice. Efficacy
outcomes included procedure success-rate, viscerotomy creation and closure and
operation time. Safety outcomes included mortality, infection, toxic or adverse
effects, pain, intraoperative/procedural complications and recovery times.
Data collection and analysis – Data from the included studies were extracted by the
ASERNIP-S researcher using standard data extraction tables developed a priori and
checked by a second researcher.
Results
The evidence base for this review was very limited, as there were no comparative
studies and all the 22 included studies were conducted in animals, their purpose
being to test the feasibility of NOTES. There were no comparative studies, study
numbers were low, and safety and efficacy outcomes were limited, thus it was
difficult to compare the safety and efficacy of using NOTES to perform intra-
abdominal surgery with existing techniques. However, it can be determined that at
the present stage of development, NOTES does not appear to be as safe or effective
as current surgical techniques. This indicates that the use of NOTES for intra-

* Translumenal is used in the trademarked name ‘Natural Orifice Translumenal
Endoscopic Surgery’, however transluminal is accepted Australian version of the
word.
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ABDOMINAL SURGERY – JULY 2007 -
abdominal surgery requires further development before it can be considered in a
clinical setting. Although intra-abdominal access via oral, anal or urethral orifices
could be achieved reliably in all cases, the evidence does not indicate the optimal
access route and method. Viscerotomy closure could not be achieved reliably in all
cases and risk of peritoneal infection has not been adequately minimised.
Although the majority of interventions were able to be performed in animals using
NOTES, a number of technical problems were encountered that will need to be
resolved. The large number of abstracts relating to NOTES at the recent SAGES
2007 meeting suggests that this area of surgery is developing rapidly and accordingly,
the evidence base will increase substantially. The review does indicate that it is
feasible to use NOTES for some intra-abdominal surgical procedures, however it is
too early to determine if these will be comparable to current procedures and if the
advantages of using NOTES outweigh the disadvantages.
Classification and Recommendations
Classifications
Evidence rating
The available evidence was assessed as being poor.
Safety
At this point in time, NOTES for intra-abdominal surgery is less safe than
laparoscopic and laparotomic alternatives.
Efficacy
Presently, NOTES for intra-abdominal surgery is currently less efficacious than
laparoscopic and laparotomic alternatives.
Clinical and Research Recommendations
NOTES is still in early stages of development and more robust technologies will be
needed to achieve reliable closure and overcome technical challenges. Well-managed
human studies need to be conducted to determine the safety and efficacy of NOTES
in a clinical setting. This may be approached by performing hybrid
NOTES/laparoscopic procedures, which may help to evaluate the safety of NOTES
in a human model, before moving into larger trials. NOTES procedures and studies
should be performed under strict guidelines, such as the membership criteria
developed by NOSCAR.

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Important note
The information contained in this report is a distillation of the best available evidence
located at the time the searches were completed as stated in the protocol. Please
consult with your medical practitioner if you have further questions relating to the
information provided, as the clinical context may vary from patient to patient.
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