Safety and efficacy outcomes
It was apparent that although technically possible to perform many of the procedures
using NOTES, they have not yet been optimised for maximum effectiveness and
minimisation of risk. Substantial refinement is required before they can be compared
with established procedures in a clinical setting.
Although many interventions could be successfully performed using different
approaches and orifices (oral, anal or urethral), these methods were not directly
compared. Therefore optimal methods for performing NOTES could not be
determined. Transvaginal access was also used in studies presented at the 2007
SAGES meeting, indicating the potential of using this access site for NOTES. The
- ASERNIP-S REVIEW OF NATURAL ORIFICE TRANSLUMENAL ENDOSCOPIC SURGERY (NOTES)TM FOR INTRAABDOMINAL
SURGERY – JULY 2007 -
SECTION 5 z DISCUSSION 45
combination of transgastric and transvesical access appeared to be advantageous
when performing NOTES cholecystectomies, particularly in manipulating the
gallbladder, however this needs further investigation to be substantiated. Similarly,
combining transgastric and transcolonic access was shown to be advantageous for
organ manipulation and visualisation in studies presented at the 2007 SAGES
meeting.
In all accounts, cholecystectomy performed using NOTES was challenging, but
could be successfully performed. News reports state that this procedure was
successfully performed in a 66 year old woman by Bessler at the Columbia University
Medical Center, New York, as part of an ongoing trial, with no complications
reported (Grady 2007; The Age 2007; USGI Medical 2007). This suggests that the
procedure is potentially transferable to humans, but peer-reviewed data will need to
be produced before any conclusions may be drawn.
Although the 100% success rate for peroral transgastric appendicectomeis is
testament to the procedure’s feasibility, both the small sample size and the fact that it
was a model appendicectomy indicate the need for further studies. Similarly, the
small sample size for transgastric splenectomies does not indicate much more than
the feasibility of the procedure. The 100% success rate of 31 NOTES procedures
involving female reproductive organs indicates the potential for the use of NOTES
for the performance of intra-abdominal surgery. NOTES female reproductive
procedures are not likely to be adopted and were chosen for study due to their
simplicity.
The reported success of using NOTES to provide temporary diaphragm pacing in
one study shows definite potential for this developmental procedure. The advantages
of using NOTES to perform this intervention are more apparent than for most of
the other interventions tested. When used in ICU patients with a PEG tube, there is
no need to create a new gastrotomy, so the procedure is truly minimally invasive. The
importance of minimising invasive procedures is higher for ICU patients, for whom
even a small laparoscopic wound can pose potentially dangerous complications.
The efficacy of specific aspects of NOTES procedures such as viscerotomy creation
and closure, was more easily measurable than the efficacy of the interventions. The
development of NOTES has attracted the attention of many prominent surgeons
and gastroenterologists, who have formed collaborations to identify concerns and
challenges in the development of NOTES. A working group established at the
Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) leadership
meeting in Chicago in 2005 developed guidelines for the implementation of NOTES,
which were outlined in a resulting ‘NOTES White Paper’ (Rattner and Kalloo 2006).
The challenges include:
peritoneal access
viscerotomy closure