Endoluminal Vacuum Therapy for the Treatment of Anastomotic Leakage after Anterior Rectal Resection

Súhrn

Prosakování anastomózy je nejdůležitější komplikací po (hluboké) přední resekci rekta a hlavní příčinou vysoké mortality a morbidity pacientů. Může vést ke generalizované peritonitidě, progredující k septickému stavu s multiorgánovým selháním a potenciálně fatálními následky. Navzdory mnohým vylepšením chirurgických technik nebylo dosud možné dosáhnout výrazného snížení výskytu prosakování. Na chirugickém oddělení Mnichovské univerzity v Großhadern (Department of Surgery, University of Munich - Großhadern) byla vyvinuta a klinicky ověřena inovativní endoskopická metoda léčby prosakování anastomózy. Ve spolupráci s B. Braun jsme mohli techniku endoluminální vakuové terapie dále rozvinout do tzv. techniky Endo-SPONGE (Endo-SPONGE treatment) a připravit ji jako samostatnou léčebnou metodu. V následujícím sdělení představujeme své dosavadní zkušenosti v oblasti endoluminální vakuové terapie.

Key words:
endoluminální vaková terapie – prosakování anastomózy – resekce rekta

_INTRODUCTION

Anastomotic leakage is the most important complication after (deep) anterior rectal resection, and is the main cause for the high level of patient mortality and morbidity [1–5]. It can lead to generalized peritonitis, with a severe septic progression involving multiple organ failure and potentially culminating in the death of the patient. Despite numerous improvements in the surgical technique, it has so far not been possible to reduce the leakage rate significantly [6, 7]. An innovative endoscopic method for treating anastomotic leakage has now been developed and established clinically at the Department of Surgery, University of Munich - Großhadern [8]. Working together with B. Braun, we have been able to develop the technique of endoluminal vacuum therapy further into the Endo-SPONGE treatment, and prepare it as an autonomous therapeutic method. In the following report we present our experiences to date in the area of endoluminal vacuum therapy.

Clinically manifest anastomotic leakages occur in approx. 10–15% of patients following rectal resection [1, 2, 9–12]. The frequency depends on various patient characteristics, the height of the anastomosis and the prior treatment in the case of carcinomas. The possibilities and therapeutic principles concerning anastomotic leakage remain the subject of controversial discussion to this day. The spectrum of possible treatments ranges from conservative measures such as broad antiobiotic coverage, through drainage and endoscopic irrigation up to surgical revision with stoma placement, a Hartmann operation or, finally, abdominoperineal exstirpation. The particular procedure varies according to the point in time, the extent and localization of the anastomotic leakage, as well as the efficiency of the secretion drainage and the clinical condition of the patient [13–18]. No controlled studies yet exist on the various different methods for treating anastomotic leakages [19].

ENDO-SPONGE IN CLINICAL USE- PROCEDURE, INDICATION AND RESULTS

In anastomotic leakage, the action of the sphincter causes a build up of gas and infected secretion into the leakage cavity, resulting in increasing infection in the minor pelvis (Fig. 1). Even where the inflammatory processes in the minor pelvis are local and limited, wound healing in the leakage cavity is impeded by the repeated influx of infected secretion. This can lead to the formation of a presacral cavity with a complex fistula system. In addition to cleaning up the local situation, therefore, one fundamental objective in the treatment of anastomotic leakage is to drain the infected secretion effectively in order to achieve clean wound conditions. Endoscopic debridement and irrigation can also be used to clean away the local leakage in a less invasive manner than through surgery. However, the basic problem with purely endoscopic treatment of anastomotic leakage lies in the short term drainage of the leakage cavity, which is restricted to the duration of the endoscopic treatment. By contrast, using the Endo-SPONGE technique, it is possible to achieve continuous drainage of secretion from the leakage cavity with simultaneous debridement, promotion of granulation and mechanical reduction in size.

A special feature here is that the basic principles of septic wound treatment are applied in anastomotic leakage therapy, whilst new developments in chronic wound treatment are also transferred into endoscopic wound therapy.

ENDOLUMINAL VACUUM THERAPY WITH THE ENDO-SPONGE SYSTEM

In vacuum therapy of open wounds, an open-pored sponge is applied to a wound, sealed with a film and connected to a vacuum source. The basic principle of endoluminal vacuum therapy consists in inserting an open-pored sponge into the leakage cavity using a flexible endoscope. A drainage tube connected to the sponge is routed through the anus and connected to a low vacuum wound drainage system. Through the application of suction, effective continuous drainage is achieved and a build up of secretion in the cavity is avoided. The sponge in the leakage cavity induces a cleaning away of fibrin coatings as well as shrinking and cleaning the cavity.

The sponge is cut to fit the size of the leakage cavity, which is established endoscopically. It is securely connected to the drainage tube. Depending on the size of the cavity, it can be necessary to use more than one sponge simultaneously.

THE ENDO-SPONGE APPLICATION SYSTEM

The Endo-SPONGE application system consists of a newly developed overtube for the endoscope in combination with a pusher to push the sponge system forward. This permits the simple and safe insertion of the sponge system into the leakage cavity. The special configuration of the overtube maintains the flexibility of the endoscope during insertion. The pusher is used to push the sponge system forward and position it in the cavity.

THE TREATMENT PROCEDURE

The treatment is typically performed with the patient lying on the left side. Light sedation and analgesia may be required. To begin the treatment, the overtube is pushed onto the endoscope and inserted together with the endoscope up to the end of the leakage cavity (Fig. 2). If there is a large leakage cavity behind a small leakage, it may be necessary to widen the gap carefully to allow the endoscope to pass through. Under vision, the overtube is pushed forward over the stationary endoscope until its tip reaches the end of the leakage cavity (Fig. 3). The overtube is held in this position and the endoscope is removed. Now the sponge system is compressed and pushed into the overtube with the help of Askina^® gel. Then the pusher is guided over the sponge system drainage tube (Fig. 4) and used to push the entire sponge system through the insertion tube up to its distal end, bringing it right to the end of the leakage cavity. The pusher is now held firmly in place and the overtube is drawn back, allowing the sponge to unfold in the cavity (Fig. 5). In large leakage cavities, it may be necessary to insert additional sponge systems, in order to ensure complete contact of the sponges with the wall of the leakage cavity. After the sponge has unfolded fully, the application system is removed. The free end of the sponge system drainage tube, which is routed through the anus, is connected with the Redyrob Trans Plus^® as a low vacuum source (Fig. 6). Finally, the correct position of the sponge is checked endoscopically, and then the suction is applied. The sponge should only fill the leakage cavity, and should have no contact with the mucous membrane.

The system is sealed only through the surrounding tissue and the resting tone of the sphincter. Additional use of a film for sealing, as in open vacuum therapy, is not necessary.

The sponge system is changed every 48–72 hours. To remove the sponge, the drainage tube is disconnected from the vacuum source and pulled with increasing strength until the sponge comes free of the cavity and can be pulled out through the anus. Removal of the sponge is facilitated through prior irrigation with 0.9% saline solution to remove granulation tissue from the pores. The sponge system is finally removed peranally.

Indication: endoscopically accessible leakage cavity with no generalized peritonitis

Where an anastomotic leakage with generalized peritonitis exists, the primary indication is for open revision! However, if an anastomotic leakage is suspected clinically and there are no signs of generalized peritonitis, the patients are first of all examined with a flexible endoscope. The flexible endoscope examination with a gastroscope offers the following essential advantages over rigid rectoscopy: much smaller quantities of air are required, since the air can be applied in a very controlled manner and according to need. Furthermore, flexible endoscopy provides a better overview and places less mechanical strain on the anastomosis region.

If leakage of the anastomosis can be demonstrated endoscopically, the extent of the anastomotic leakage with regard to any build up of secretion or abscess behind it will decide on the further procedure. If there is no endoscopically identifiable build up of secretion or abscess with cavity formation, a CT scan of the abdomen is performed to exclude any possible build up that is not identifiable endoscopically. If here too there is no evidence of any build up of secretion, the leakage is treated conservatively under close-meshed endoscopic control. For dot shaped and small anastomotic leakages, local fibrin adhesion is considered. If a secretion build up is identified endoscopically, endoscopic vacuum therapy will be performed. After the first sponge system has been inserted, the patient is placed under close clinical control. If there is a clinical deterioration, surgical revision must be considered. Because of the effective drainage properties of the Endo-SPONGE therapy, it may be possible to dispense with a protective stoma in selected individual cases. However, this still remains the exception and must only take place under close consultation between the surgeon, the endoscopic treatment team and the patient.

Example: Using the Endo-SPONGE system to treat a large anastomotic leakage after deep anterior rectal resection with TME and creation of a J pouch

Příklad: Použití systému Endo-SPONGE v léčbě velkého prosakování anastomózy po hluboké přední resekci rekta s TME a vytvoření ileoanálního pouche (J pouch).

_RESULTS

Since 2001, more than 60 patients have been treated in our hospital using endoluminal vacuum therapy with over 600 individual applications. Among the patients following primary rectal resection, the extent of the anastomotic leakage ranged from 1/4 of the circumference to complete dehiscence of the anastomosis. After commencing treatment with the Endo-SPONGE therapy, a rapid decline in the clinical and serological inflammation parameters is evident among the patients. Endoscopically, the formation of granulation tissue with simultaneous reduction in fibrin coatings and necrotic tissue in the leakage cavity can quickly be observed, resulting in a fast reduction in size of the leakage cavity during the course of the treatment. The size of the new sponges applied during the course of the treatment is adapted to fit the decreasing dimensions of the leakage cavity. When the residual cavity measures approximately 1 x 0.5 cm, the treatment with Endo-SPONGE is terminated, since a further reduction of the sponge size is no longer technically possible at this size. For the overwhelming majority of our patients, the residual defect, a small hollow, healed spontaneously. In some patients, fibrin adhesion was performed endoscopically after the Endo-SPONGE treatment in order to definitively close residual canals smaller than 1.5 cm. During sponge changes, there were isolated cases of minor haemorrhaging from the strongly vascularised granulation tissue that had grown into the sponge. External sealing of the system was not necessary in any of the patients and no dislocation of the sponge system occurred during treatment.

With an average treatment duration with the Endo-SPONGE method of around 34 days and 11 sponge changes per patient, definitive healing of the anastomotic leakage can be achieved in most patients 20. For a majority of the patients, the treatment is continued nowadays by us on an out-patient basis after their discharge from hospital.

After beginning the Endo-SPONGE therapy, the patients report a rapid improvement in the development of unpleasant odours through the effective drainage of the infected secretion. Combined with the fast decline in clinical symptoms through the efficient treatment of the septic focus, this leads to a very high level of patient compliance as regards the new form of treatment. During the first treatment sessions, some patients experienced pain when the suction was applied. However, this could usually be adequately alleviated by administering nonopioid analgesics.

_CONCLUSION

The method presented here permits endoscopic treatment of even major anastomotic leakages. Until now, endoscopic treatment of anastomotic leakage was regarded as indicated above all for small and clinically non-apparent dehiscences, because of the demonstrated limitations. However, in our patient collective it was evident that larger dehiscences in particular were also suitable for the treatment method presented here. A precondition for the applicability of the method for large leakages is a cavity that is accessible with an endoscope. Now as before, where generalized peritonitis exists, a clear indication for surgical revision must be made. It appears possible to reduce the high mortality of patients with anastomotic leakage through the avoidance of surgical reinterventions whilst at the same time preserving the sphincter function. Last but not least, the possibility of continuing the treatment on an out-patient basis means that the length of time the patient has to remain in hospital can be reduced.

Conflict of interest

Worldwide patent is pending for this method (R. Weidenhagen & U. Griitzner). A licence agreement for this method with KCI, San Antonio, Texas was signed 2002 and terminated in 2004. A new licence agreement was signed in 2007 with BBraun Melsungen AG, Germany.

Copyright of Figure 1-6 by BBraun Melsungen AG Literature

Dr. med. R. Weidenhagen

Department of Surgery Klinikum Grosshadern

Ludwig-Maximilian-University of Munich

D-81377 Munich

Germany

e-mail: Rolf.Weidenhagen@med.uni-muenchen.de