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364
Biomedical Engineering in Gastrointestinal Surgery
Ontheotherhand,thecomparativelylongdistancebetweenthe mouth and the stomach enables indirect manipulations only. Even if the endoscope is more or less sterile, it has to pass the mouth and the hypopharynx and may be contaminated with these highly contamina ted areas.
One major issue is to find an appropriate entrance point which is both suitable for the surgery considered and safe. The stomach is covered by the left liver lobes, flanked by the spleen, liver, and colon, and is posi­tioned above the pancreas.
Kantsevoy modified the percutaneous endoscopic ga strostomy (PEG) technique to gain safe access to the abdominal cavity (
Fig. 9.10) for NOTES. The puncture site is enlarged using a
Figure 9.10 Technique of percutaneous endoscopic gastrostomy (PEG)-based crea­tion of a transgastric approach into the abdomen. (A) Endoscopic view of the stom­ach: The anterior wall is illuminated. The light can be seen from the outside (diaphanoscopy). (B) External puncture on the stomach. A needle is inserted through the skin, the abdominal and anterior gastric wall into the lumen of the stomach. (C) Guidewire insertion through the puncture site. (D) The guidewire is used to deploy a traction papillotome to enlarge the puncture site. Courtesy: Prof. Dr. S. v.
Delius, Klinikum rechts der Isar.
Combined Laparoscopic-Endoscopic Procedures and NOTES
Figure 9.11 (A) Veress needle to create a pneumoperitoneum. (B) As soon as the pneumoperitoneum is created, an incision can be made into the anterior gastric wall using the needle knife without too much risk. (C) The incision is enlarged by balloon dilatation.
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papillotome (see Chapter 8: Inter ventional Flexible Endoscopy). Alternatively, the puncture site can be enlarged by dilatation using a balloon catheter.
This enlarged incision of the PEG technique serves as the access point
of the endoscope into the abdominal cavity
[13].
The Pneumoperitoneum Technique
An alternative technique is to establish a pneumoperitoneum first to
create a certain anterior gastric wall (
Fig. 9.11). Under normal circum-
stances, the middle part of the anterior gastric wall is not covered by adja­cent tissue.
The pneumoperitoneum technique can be helpful if the instillation of
disinfectant fluids is additionally considered.
The Tunneling Technique
One major concern when using an interior entry point for NOTES is a safe closure of the incision once the intervention has been finished. The submucosal tunneling technique was developed to provide a valve-like mechanism to close the stomach (
Fig. 9.12).
Various different techniques including endosonography have been tried out experimentally but uptonow,nostandardprocedure exists.
9.2.1.2 Transurethral Approach
Among the various natural openings of the human anatomy, the urethra/ urinary bladder is the only one which is (under regular circumstances) free of bacterial contamination. Insofar, the transurethral would be the
366
Biomedical Engineering in Gastrointestinal Surgery
Figure 9.12 Submucosal tunneling method: After withdrawal of the instrument, the submucosal tunnel collapses and seals the transmuscular hole. (A) Saline injected into the submucosa. (B) Needle knife mucosal/submucosal puncture. (C) Creation of submucosal space by blunt dissection and/or balloon dilation. (D) Off-site needle knife penetration of the muscularis propria with subsequent entry into the perito­neum. (E) Offset closure of muscular defect with overlying mucosal flap. From Moyer
MT, Haluck RS, Gopal J, Pauli EM, Mathew A. Transgastric organ resection solely with the prototype R-scope and the self-approximating transluminal access technique. Gastrointest Endosc 2010;72(1):1706
[14].
Combined Laparoscopic-Endoscopic Procedures and NOTES
Figure 9.13 Male (left) and female (right) genitourinary anatomy: The long, S-shaped male urethra permits the introduction of rigid instruments, but it is very difficult to position it adequately to get a suitable puncture site. Flexible endoscopes are prefer­able. The female urethra is shorter, but the sphincter even more sensitive to overdis­tension. All from M. Scholle.
367
ideal approach (Fig. 9.13). Moreover, the incision of the bladder wall can be easily and safely closed
[15].
The main drawback is that only small bore instruments (# 5mm in diameter) can be used. If large bore instruments are applied, the risk is high to overstretch the internal vesical sphincter resulting in urinary incontinence.
Schneider et al. developed a specially coated set of bougies which allows for a successful bougienage of the urethra up to 36 French (12 mm) without any harm to the sphincter (
Fig. 9.14A,B).
In male patients, flexible endoscopes are mandatory since it is impossible to leav e the urinary bladder in an adequate angle for NOTES interventions with a rigid telescope. Though currently of minor importance the transure­thral approach could potentially gain importance as an auxiliary access
[16].
9.2.1.3 Transvaginal Approach
Transvaginal surgery is well-established in gynecology since many decades. The vagina can easily be decontaminated. Even large bore instruments can be inserted without any problems and wound closure is easy and safe (
Fig. 9.15).
Most NOTES cholecystectomies are perfor med via this route. Either rig id or flexible scopes are in use. Though the complication rate is very low
[17], many—in particular young—patients are not inclined to accept
this special type of approach. Vice versa, surgeons are often concerned about long-term—real or pretended—side effects like dyspareunia due to scar formation, etc.
However, this access is only available in 50% of the patients.
368
Biomedical Engineering in Gastrointestinal Surgery
Figure 9.14 (A) A set of specially designed bougies for the sphincter of the urinary bladder: A guide wire is inserted into the abdominal cavity through the urinary blad­der wall (A). The rigid (or even flexible) bougies are applied in an ascending line (B) until finally the trocar (C) can be introduced over the bougies. (B) Sphincter manom­etry before, during, and 15 minutes after bougienage. Note the rapid recovery of the resting pressure after the interval of 15 minutes. From Schneider A. Application tech-
nique for an innovative antireflux device using Natural Orifice Translulminal Endoscopic Surgery (NOTES). Doctoral Thesis, Technical University of Munich; 2010.
9.2.1.4 Transcolonic Approach
In the early days of NOTES, the idea to use the rectosigmoid as an entry point was not very popular. The rectum is densely contaminated with (dangerous) bacteria and very difficult to clean. Any leakage of wound closure leads inevitably to life-threatening peritonitis. On the other hand, some particular advantages have to be kept in mind. If the anal sphincter is cautiously dilated, instruments with a diameter of 3.54 cm can be inserted safely without the risk of fecal incontinence (
Fig. 9.16).
Combined Laparoscopic-Endoscopic Procedures and NOTES
Figure 9.15 (A) Insertion of a trocar through the vagina (a view into the pelvis through a laparoscope). (B) A view into the vagina after the procedure: The main tro­car insertion site is closed with two stitches. An additional insertion site for a 5-mm trocar is closed by another suture. All: Courtesy: Prof. C. Zornig, Israelitisches
Krankenhaus Hamburg.
369
Figure 9.16 Flexible endoscope introduced through the rectum for the removal of the gallbladder: Most target regions can be reached straight forward. Retroflexion is not required. From M. Scholle.
After intensive scientific studies, several dedicated overtube systems
have been developed
[18,19], resulting in a rising interest in transrectal
NOTES. Often also denounced as transanal minimally invasive surgery (TaMIS), transrectal scarless colorectal surgeries are increasingly per­formed under clinical conditions.
370
Biomedical Engineering in Gastrointestinal Surgery
Figure 9.17 A new set of instruments (ISSA) designed to permit sterile sigmoid access for transcolonic surgery: (1) part flexible obturator; (2) trocar head; (3) trocar tube; (4) TEM obturator; (5) modified TEM cap; (6) modified rectoscope; (7) trocar port; (8) instrument ports; and (9) optical port. From Fiolka A, Can S, Schneider A, Wilhelm D,
Feussner H. Instrumentation and surgical technique for an innovative safe sigmoid approach for NOTES. Minim Invasive Ther Allied Technol 2008;17(6):33640.
Figure 9.18 (A) The intraabdominal fluid facilitates to identify the optimal entry site without endangering adjacent anatomical structures. (B) The flexible endoscope is advanced into the abdomen via the trocar. All from MITI.
Fiolka et al. developed an overtube for the transanal access with an
outer diameter of 18 mm (
Fig. 9.17). The front access is curved to avoid
collision with the promontory. To provide gas-tightness, a valve chamber is integrated. The specially designed trocar is inserted using a modified TEM system.
By instilling a decontaminating fluid into the abdominal cavity via a Veress needle, an artificial ascites is created. Thus, an appropriate entry site within the rectum can be selected using endorectal ultrasound (
Fig. 9.18).
At the end of the procedure, the entry site can be reliably occluded using a linear stapler under direct vision.
A similar system was recently reported
[19] which additionally
includes a balloon system to occlude the colon oralad the entry point.
Combined Laparoscopic-Endoscopic Procedures and NOTES
Figure 9.19 (A) Conventional endoscopic clips: Commonly, the mucosa is occluded only. (B) Result after 7 days post application. All from MITI.
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9.2.2 Intestinal Closure

Initially, endoscopic clips (see Chapter 8: Interventional Flexible Endoscopy) were the only tools available. However, efficacy was not very high. Both industrial companies and academic working groups strove for better solutions. Though some progress could be achieved, the problem of intestinal closure is not yet completely solved.
9.2.2.1 Clips
Endoscopists are familiar with the use of conventional endoscopic clips. Application is comparatively easy (
Fig. 9.19).
However, closure of full wall defects is unreliable since only the mucosal defect can be closed. Before the application, the edges of the defect have to be approximated which is often impossible in the case of larger lesions.
A big step forward is the development of the over-the-scope-clip as described in detail in Chapter 8, Interventional Flexible Endoscopy. The bilaterally acting forceps significantly facilitates tissue approximation. Since NOTES incisions are comparatively short, they are well covered by one single clip (
Fig. 9.20).
The clip will leave the gastrointestinal tract via naturales. If required, it can easily be removed by means of a sort of endoscopic blowpipe. Currently, the OTSC products are cleared for clinical use in the European Union, the United States, Canada, Japan, Korea, China, and selected other markets. Various alternative clips were designed, but none of them have gained clinical acceptance up to now.
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Biomedical Engineering in Gastrointestinal Surgery
Figure 9.20 The Ovesco clip occluding a NOTES entry site. Courtesy: PD Dr. D. Wilhelm, Klinikum rechts der Isar.
9.2.2.2 Suturing Devices
Since robust and secure enterostomy closure is the “Achilles heel” of NOTES, industry sensed that suturing might represent “a disruptive para­digm shift” in endoscopy. An explosion of innovative suturing devices could be observed, whereas others tried to develop bimanual operating platforms that could suture with standard surgical sutures (see
Section 9.9:
Multifunctional Endoscopes and Mechanical Platforms).
Unfortunately, none of the latter reached commercialization, but today, at least two sut uring systems are available. They are b ased upon two different principles. The first design is based upon the double­anchor principle: If the two edges of a defect can be safely g ripped by an anchor connected to a suture on each single side, they will inevitably be approximated as soon as both sutures are knotted. The principle is shown in
Fig. 9.21.
The second concept is more or less based upon the design of sewing machines. A mechanically sophisticated device was presented in the short history of NOTES (
Fig. 9.22).
The principle has been refined over the last couple of years and is now available as the OverStitch endoscopic surgical system by Apollo Endosurgery (
Fig. 9.23).
Combined Laparoscopic-Endoscopic Procedures and NOTES
Figure 9.21 (A) The first anchor is already positioned through the full-thickness of the gastrointestinal wall (right side). The needlealready loaded with the second threaded tagtargets the contralateral edge. (B) The second anchor is placed through the whole wall. (C) The so-called thread locking device is pushed forward to tie the threads together. (D) The two threads are firmly approximated and locked by the stopper. (E) Both ends of the threads are cut by a cutter device integrated into the system. Thus a safe interrupted suture line can be created.
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Figure 9.22 First prototype of the endoscopic sewing machine: (A) Starting position; (B) closed. All from MITI.

9.2.3 Flexible Staplers

Temporarily flexible linear staplers were available. They were used to per­form experimentally to accomplish Roux-en-Y bypasses, sleeve resection of the stomach, and colonic resection (
Fig. 9.24). For reasons unknown,
this type of stapler is no longer available. They certainly had the potential to stimulate the development of NOTES. Hopefully, improved flexible staplers will become available again.

9.2.4 Plicator-Like Devices

As already pointed out in Chapter 2.2: Esophagus, several innovative endo­scopic approaches were started for the endoluminal treatment of gastro­esophageal reflux disease about 15 years ago. Not many of the devices