H. Maier

The management of periprosthetic leakage in the presence of supra-oesophageal reflux after prosthetic voice rehabilitation

The objective of the study was to investigate the influence of anti-reflux medications on the management of periprosthetic leakage in laryngectomised patients with prosthetic voice rehabilitation. Sixty patients underwent laryngectomy and prosthetic voice rehabilitation. In a prospective non-randomised study, we examined the patients clinically and assessed the presence of reflux disease using 24-h dual-probe pH monitoring before and 6xa0months after oral anti-reflux treatment with proton pump inhibitors (PPIs). The severity of reflux, the effectiveness of anti-reflux therapy, and the clinical success of treatment were evaluated. Reflux parameters before and after anti-reflux therapy as well as the severity and incidence of periprosthetic leakage before and after PPI therapy were the main outcome measures. The absolute number of reflux events was 162.2 (±144.3) before treatment and 63.1 (±87.9) after treatment with PPIs (pxa0=xa00.031). The reflex area index score decreased from 327.1 (±419.3) without PPIs to 123.8 (±249.7) with PPIs (pxa0=xa00.0228). The mean DeMeester score was 108.3 (±85.4) before treatment and 47.4 (±61.7) after 6xa0months of treatment (pxa0=xa00.0557). The relative risk of periprosthetic leakage decreased to 0.5 after anti-reflux treatment. In 19 patients, leakage problems were successfully managed by rigorous treatment with PPIs. No further surgical procedures were required in these cases. Rigorous anti-reflux treatment leads to an improvement in parameters that can be assessed objectively by 24-h dual-probe pH monitoring. In the majority of patients, the symptoms associated with periprosthetic leakage can be improved or cured.

Development and (pre-) clinical assessment of a novel surgical tool for primary and secondary tracheoesophageal puncture with immediate voice prosthesis insertion, the Provox Vega Puncture Set

Development and (pre-) clinical assessment were performed of a novel surgical tool for primary and secondary tracheoesophageal puncture (TEP) with immediate voice prosthesis (VP) insertion in laryngectomized patients, the Provox Vega Puncture Set (PVPS). After preclinical assessment in fresh frozen cadavers, a multicenter prospective clinical feasibility study in two stages was performed. Stage-1 included 20 patients, and stage-2 had 27. Based on observations in stage-1, the PVPS was re-designed (decrease in diameter of the dilator from 23.5 to 18xa0Fr.) and further used in stage-2. Primary outcome measure was immediate VP insertion without requiring additional instruments. Secondary outcome measures for comparison of the new with the traditional TEP procedure were: appreciation, ease of use, time consumption, estimated surgical risks and overall preference. A mini-max two-stage study design was used to establish the required sample size. In stage-1, dilatation forces were considered too high in patients with a fibrotic TE wall. With the final thinner version of the PVPS, VPs were successfully inserted into the TEP in ‘one-go’ in 24/27 (89%) of TEPs: 20 primary and 7 secondary. Participating surgeons rated appreciation, ease of use, time consumption and estimated surgical risks as better. Related adverse events were few and minor. The new PVPS appeared to be the preferred device by all participating surgeons. This study shows that the novel, disposable PVPS is a useful TEP instrument allowing quick and easy insertion of the VP in the vast majority of cases without requiring additional instruments.

Hands-free speech after surgical voice rehabilitation with a Provox® voice prosthesis: experience with the Provox FreeHands HME tracheostoma valve® system

Excellent results have been reported with the use of voice prostheses for the rehabilitation of laryngectomees. Patients, however, consider it a disadvantage that the tracheostoma must be closed manually for speech production. This limits their ability to simultaneously communicate by gesture or to work with both hands. An automatic tracheostoma valve helps patients overcome this problem. We describe a prospective clinical trial evaluating our experience with the Provox FreeHands HME Automatic Tracheostoma Valve® system. Twenty-four laryngectomees were randomly selected from the patients who had undergone laryngectomy at the ENT Department. Immediately, after 4xa0weeks and 6xa0months later having been fitted with a Provox FreeHands HME®, the patients were asked to complete a questionnaire in order to assess their satisfaction, voice quality, wearing comfort, fixation, potential problems, and the effectiveness of the HME cassette. In addition, we investigated relevant voice quality parameters including dynamics range, frequency range of the speaking voice, and maximum phonation time. Seven patients discontinued the study due to problems of securing the valve to the skin (four patients) or recurrent cancer (three patients). Ten of the remaining 17 patients wore the valve daily for an average of 8.4xa0h. A total of 88% of the patients considered it a great advantage to be able to speak without having to use their hands. With the Provox FreeHands HME®, maximum phonation time was 8.7 (±6.2)xa0s and the dynamic range was 21.9 (±5.8) decibels. The results show that the Provox FreeHands HME Automatic Tracheostoma Valve® system not only allows hands-free speech but is also associated with excellent compliance and good voice rehabilitation.

[A novel puncture instrument: the Provox-Vega® puncture set. Its use in voice prosthesis insertion following laryngectomy].

BACKGROUNDnThe use of voice prostheses has been considered the gold standard in voice rehabilitation following laryngectomy for the last 20xa0years. Insertion is generally performed as a primary procedure during laryngectomy or as a secondary procedure with a re-usable trocar or rigid esophagoscope, a guidewire and anatomic hemostatic forceps. The use of these instruments requires a certain level of experience on the one hand, while on the other use of a trocar and subsequent manipulation with the hemostatic forceps can lead to tissue trauma around the membranous wall or damage to the voice prosthesis. We present the results of a phase I/II study using a novel atraumatic puncture set for primary and secondary insertion of voice prostheses.nnnPATIENTS AND METHODSnOnce patients had been fully informed and given their consent, the Provox-Vega® puncture set was used in 21xa0patients in either a primary (16) or a secondary (5) procedure. All procedures were documented on video, while approach, complications and surgical success were recorded using a questionnaire.nnnRESULTSnThe average surgical time was 83.5 (±u200919.12)xa0s for primary voice prosthesis insertion and 212.57 (±u200993.03)xa0s in secondary procedures. The prosthesis could be inserted without complication in 19xa0patients, while a longer prosthesis needed to be selected intraoperatively in two patients due to a thick membranous wall. No serious complications were observed. One patient incurred a discrete injury to the mucosa of the esophageal posterior wall.nnnCONCLUSIONnThe Provox-Vega® puncture set proved itself to be a safe aid in the insertion of voice prostheses. It is significantly easier to use than other systems and tissue trauma is minimal. In most cases, no further instruments were required.ZusammenfassungHintergrundDie Verwendung von Stimmprothesen gilt seit etwa 20 Jahren als Goldstandard in der Stimmrehabilitation nach totaler Laryngektomie. Die Versorgung erfolgt in der Regel als primäre Anlage im Rahmen der Laryngektomie oder als sekundäre Anlage im Intervall mit einem wiederverwendbaren Trokar oder starren Ösophagoskop, einem Führungsdraht und anatomischen Gefäßklemmen. Der Einsatz dieses Instrumentariums erfordert zum einen eine gewisse Übung, zum anderen kann es durch die Verwendung des Trokars und die nachfolgende Manipulation mit den Gefäßklemmen zu einer Traumatisierung des Gewebes im Bereich des Paries membranaceus bzw. zu Beschädigungen der Stimmprothese kommen. Wir stellen die Ergebnisse einer Phase-I/II-Studie bei Verwendung eines neuen atraumatischen Punktionssets zur primären und sekundären Stimmprothesenanlage vor.Patienten und MethodenBei 21 Patienten erfolgte nach Aufklärung und Unterschrift die Verwendung des Provox-Vega®-Punktionssets im Rahmen der primären (16) oder sekundären (5) Stimmprothesenanlage. Bei allen Prozeduren wurde die Op. videodokumentiert und mittels eines Fragebogens Handhabung, Komplikationen und Op.-Erfolg erfasst.ErgebnisseDie durchschnittliche Op.-Dauer lag bei primären Stimmprothesenanlagen bei 83,5 (±u200919,12)xa0s, bei sekundären Anlagen bei 212,57 (±u200993,03)xa0s. Bei 19 Patienten konnte die Prothese problemlos eingebracht werden, bei 2xa0Patienten musste im Eingriff wegen eines verdickten Paries membranaceus auf eine längere Prothese gewechselt werden. Schwerwiegende Komplikationen wurden in keinem Fall beobachtet. Bei einem Patienten kam es im Rahmen der Sekundärpunktion zu einer diskreten Verletzung der Schleimhaut der Ösophagushinterwand.SchlussfolgerungDas Provox-Vega®-Punktionsset hat sich im Rahmen der Studie als sicheres Hilfsmittel zur Stimmprothesenanlage bewährt. Die Handhabung ist gegenüber anderen Systemen deutlich vereinfacht, eine Traumatisierung des Gewebes wird minimiert. In den meisten Fällen ist kein weiteres Instrumentarium notwendig.AbstractBackgroundThe use of voice prostheses has been considered the gold standard in voice rehabilitation following laryngectomy for the last 20xa0years. Insertion is generally performed as a primary procedure during laryngectomy or as a secondary procedure with a re-usable trocar or rigid esophagoscope, a guidewire and anatomic hemostatic forceps. The use of these instruments requires a certain level of experience on the one hand, while on the other use of a trocar and subsequent manipulation with the hemostatic forceps can lead to tissue trauma around the membranous wall or damage to the voice prosthesis. We present the results of a phase I/II study using a novel atraumatic puncture set for primary and secondary insertion of voice prostheses.Patients and methodsOnce patients had been fully informed and given their consent, the Provox-Vega® puncture set was used in 21xa0patients in either a primary (16) or a secondary (5) procedure. All procedures were documented on video, while approach, complications and surgical success were recorded using a questionnaire.ResultsThe average surgical time was 83.5 (±u200919.12)xa0s for primary voice prosthesis insertion and 212.57 (±u200993.03)xa0s in secondary procedures. The prosthesis could be inserted without complication in 19xa0patients, while a longer prosthesis needed to be selected intraoperatively in two patients due to a thick membranous wall. No serious complications were observed. One patient incurred a discrete injury to the mucosa of the esophageal posterior wall.ConclusionThe Provox-Vega® puncture set proved itself to be a safe aid in the insertion of voice prostheses. It is significantly easier to use than other systems and tissue trauma is minimal. In most cases, no further instruments were required.

Ionisiertes Calcium und Totalcalcium im Parotisspeichel bei Normalpersonen und essentiellen Hypertonikern

SummaryThe development of Ca2+-selective disk-electrodes and of a synthetic Ca2+-carrier has led to an enhanced technique of determination of the ionized calcium in the parotid saliva. In ten male and eight female normal persons and in nine patients with essential hypertension the salivary calcium concentration was examined.Both the ionized and the total calcium was by 22% resp. 16% lower in normal females than in normal males. Increasing salivary flow rates rised the calcium concentration with almost unchanged quotients of Ca2+/Catotal. In hypertensive patients an elevated Ca2+-concentration was observed, also the total calcium was significantly increased. The salivary flow rate influenced the Ca2+/Catotal quotient considerably in this group.

Neues Punktionsinstrumentarium: Provox-Vega®-Punktionsset

BACKGROUNDnThe use of voice prostheses has been considered the gold standard in voice rehabilitation following laryngectomy for the last 20xa0years. Insertion is generally performed as a primary procedure during laryngectomy or as a secondary procedure with a re-usable trocar or rigid esophagoscope, a guidewire and anatomic hemostatic forceps. The use of these instruments requires a certain level of experience on the one hand, while on the other use of a trocar and subsequent manipulation with the hemostatic forceps can lead to tissue trauma around the membranous wall or damage to the voice prosthesis. We present the results of a phase I/II study using a novel atraumatic puncture set for primary and secondary insertion of voice prostheses.nnnPATIENTS AND METHODSnOnce patients had been fully informed and given their consent, the Provox-Vega® puncture set was used in 21xa0patients in either a primary (16) or a secondary (5) procedure. All procedures were documented on video, while approach, complications and surgical success were recorded using a questionnaire.nnnRESULTSnThe average surgical time was 83.5 (±u200919.12)xa0s for primary voice prosthesis insertion and 212.57 (±u200993.03)xa0s in secondary procedures. The prosthesis could be inserted without complication in 19xa0patients, while a longer prosthesis needed to be selected intraoperatively in two patients due to a thick membranous wall. No serious complications were observed. One patient incurred a discrete injury to the mucosa of the esophageal posterior wall.nnnCONCLUSIONnThe Provox-Vega® puncture set proved itself to be a safe aid in the insertion of voice prostheses. It is significantly easier to use than other systems and tissue trauma is minimal. In most cases, no further instruments were required.ZusammenfassungHintergrundDie Verwendung von Stimmprothesen gilt seit etwa 20 Jahren als Goldstandard in der Stimmrehabilitation nach totaler Laryngektomie. Die Versorgung erfolgt in der Regel als primäre Anlage im Rahmen der Laryngektomie oder als sekundäre Anlage im Intervall mit einem wiederverwendbaren Trokar oder starren Ösophagoskop, einem Führungsdraht und anatomischen Gefäßklemmen. Der Einsatz dieses Instrumentariums erfordert zum einen eine gewisse Übung, zum anderen kann es durch die Verwendung des Trokars und die nachfolgende Manipulation mit den Gefäßklemmen zu einer Traumatisierung des Gewebes im Bereich des Paries membranaceus bzw. zu Beschädigungen der Stimmprothese kommen. Wir stellen die Ergebnisse einer Phase-I/II-Studie bei Verwendung eines neuen atraumatischen Punktionssets zur primären und sekundären Stimmprothesenanlage vor.Patienten und MethodenBei 21 Patienten erfolgte nach Aufklärung und Unterschrift die Verwendung des Provox-Vega®-Punktionssets im Rahmen der primären (16) oder sekundären (5) Stimmprothesenanlage. Bei allen Prozeduren wurde die Op. videodokumentiert und mittels eines Fragebogens Handhabung, Komplikationen und Op.-Erfolg erfasst.ErgebnisseDie durchschnittliche Op.-Dauer lag bei primären Stimmprothesenanlagen bei 83,5 (±u200919,12)xa0s, bei sekundären Anlagen bei 212,57 (±u200993,03)xa0s. Bei 19 Patienten konnte die Prothese problemlos eingebracht werden, bei 2xa0Patienten musste im Eingriff wegen eines verdickten Paries membranaceus auf eine längere Prothese gewechselt werden. Schwerwiegende Komplikationen wurden in keinem Fall beobachtet. Bei einem Patienten kam es im Rahmen der Sekundärpunktion zu einer diskreten Verletzung der Schleimhaut der Ösophagushinterwand.SchlussfolgerungDas Provox-Vega®-Punktionsset hat sich im Rahmen der Studie als sicheres Hilfsmittel zur Stimmprothesenanlage bewährt. Die Handhabung ist gegenüber anderen Systemen deutlich vereinfacht, eine Traumatisierung des Gewebes wird minimiert. In den meisten Fällen ist kein weiteres Instrumentarium notwendig.AbstractBackgroundThe use of voice prostheses has been considered the gold standard in voice rehabilitation following laryngectomy for the last 20xa0years. Insertion is generally performed as a primary procedure during laryngectomy or as a secondary procedure with a re-usable trocar or rigid esophagoscope, a guidewire and anatomic hemostatic forceps. The use of these instruments requires a certain level of experience on the one hand, while on the other use of a trocar and subsequent manipulation with the hemostatic forceps can lead to tissue trauma around the membranous wall or damage to the voice prosthesis. We present the results of a phase I/II study using a novel atraumatic puncture set for primary and secondary insertion of voice prostheses.Patients and methodsOnce patients had been fully informed and given their consent, the Provox-Vega® puncture set was used in 21xa0patients in either a primary (16) or a secondary (5) procedure. All procedures were documented on video, while approach, complications and surgical success were recorded using a questionnaire.ResultsThe average surgical time was 83.5 (±u200919.12)xa0s for primary voice prosthesis insertion and 212.57 (±u200993.03)xa0s in secondary procedures. The prosthesis could be inserted without complication in 19xa0patients, while a longer prosthesis needed to be selected intraoperatively in two patients due to a thick membranous wall. No serious complications were observed. One patient incurred a discrete injury to the mucosa of the esophageal posterior wall.ConclusionThe Provox-Vega® puncture set proved itself to be a safe aid in the insertion of voice prostheses. It is significantly easier to use than other systems and tissue trauma is minimal. In most cases, no further instruments were required.

Beeinflussung speichelchemischer Parameter in Abhängigkeit vom Menstruationszyklus

SummaryThe influence of different sexual hormone levels during menstrual cycle on the composition of human parotid saliva was investigated.During midcycle there were significantly enhanced concentrations of ionized calcium, total calcium, inorganic phosphate and sodium in parotid saliva. The changes in chloride concentrations were parallel to that of sodium and the excretion of potassium was inverse to that of sodium. The maximal output of total protein andα-amylase was found during midcycle and menstruation.

Neues Punktionsinstrumentarium: Provox-Vega®-Punktionsset@@@A novel puncture instrument: the Provox-Vega® puncture set: Anwendung beim Einbringen einer Stimmprothese nach Laryngektomie@@@Its use in voice prosthesis insertion following laryngectomy

BACKGROUNDnThe use of voice prostheses has been considered the gold standard in voice rehabilitation following laryngectomy for the last 20xa0years. Insertion is generally performed as a primary procedure during laryngectomy or as a secondary procedure with a re-usable trocar or rigid esophagoscope, a guidewire and anatomic hemostatic forceps. The use of these instruments requires a certain level of experience on the one hand, while on the other use of a trocar and subsequent manipulation with the hemostatic forceps can lead to tissue trauma around the membranous wall or damage to the voice prosthesis. We present the results of a phase I/II study using a novel atraumatic puncture set for primary and secondary insertion of voice prostheses.nnnPATIENTS AND METHODSnOnce patients had been fully informed and given their consent, the Provox-Vega® puncture set was used in 21xa0patients in either a primary (16) or a secondary (5) procedure. All procedures were documented on video, while approach, complications and surgical success were recorded using a questionnaire.nnnRESULTSnThe average surgical time was 83.5 (±u200919.12)xa0s for primary voice prosthesis insertion and 212.57 (±u200993.03)xa0s in secondary procedures. The prosthesis could be inserted without complication in 19xa0patients, while a longer prosthesis needed to be selected intraoperatively in two patients due to a thick membranous wall. No serious complications were observed. One patient incurred a discrete injury to the mucosa of the esophageal posterior wall.nnnCONCLUSIONnThe Provox-Vega® puncture set proved itself to be a safe aid in the insertion of voice prostheses. It is significantly easier to use than other systems and tissue trauma is minimal. In most cases, no further instruments were required.ZusammenfassungHintergrundDie Verwendung von Stimmprothesen gilt seit etwa 20 Jahren als Goldstandard in der Stimmrehabilitation nach totaler Laryngektomie. Die Versorgung erfolgt in der Regel als primäre Anlage im Rahmen der Laryngektomie oder als sekundäre Anlage im Intervall mit einem wiederverwendbaren Trokar oder starren Ösophagoskop, einem Führungsdraht und anatomischen Gefäßklemmen. Der Einsatz dieses Instrumentariums erfordert zum einen eine gewisse Übung, zum anderen kann es durch die Verwendung des Trokars und die nachfolgende Manipulation mit den Gefäßklemmen zu einer Traumatisierung des Gewebes im Bereich des Paries membranaceus bzw. zu Beschädigungen der Stimmprothese kommen. Wir stellen die Ergebnisse einer Phase-I/II-Studie bei Verwendung eines neuen atraumatischen Punktionssets zur primären und sekundären Stimmprothesenanlage vor.Patienten und MethodenBei 21 Patienten erfolgte nach Aufklärung und Unterschrift die Verwendung des Provox-Vega®-Punktionssets im Rahmen der primären (16) oder sekundären (5) Stimmprothesenanlage. Bei allen Prozeduren wurde die Op. videodokumentiert und mittels eines Fragebogens Handhabung, Komplikationen und Op.-Erfolg erfasst.ErgebnisseDie durchschnittliche Op.-Dauer lag bei primären Stimmprothesenanlagen bei 83,5 (±u200919,12)xa0s, bei sekundären Anlagen bei 212,57 (±u200993,03)xa0s. Bei 19 Patienten konnte die Prothese problemlos eingebracht werden, bei 2xa0Patienten musste im Eingriff wegen eines verdickten Paries membranaceus auf eine längere Prothese gewechselt werden. Schwerwiegende Komplikationen wurden in keinem Fall beobachtet. Bei einem Patienten kam es im Rahmen der Sekundärpunktion zu einer diskreten Verletzung der Schleimhaut der Ösophagushinterwand.SchlussfolgerungDas Provox-Vega®-Punktionsset hat sich im Rahmen der Studie als sicheres Hilfsmittel zur Stimmprothesenanlage bewährt. Die Handhabung ist gegenüber anderen Systemen deutlich vereinfacht, eine Traumatisierung des Gewebes wird minimiert. In den meisten Fällen ist kein weiteres Instrumentarium notwendig.AbstractBackgroundThe use of voice prostheses has been considered the gold standard in voice rehabilitation following laryngectomy for the last 20xa0years. Insertion is generally performed as a primary procedure during laryngectomy or as a secondary procedure with a re-usable trocar or rigid esophagoscope, a guidewire and anatomic hemostatic forceps. The use of these instruments requires a certain level of experience on the one hand, while on the other use of a trocar and subsequent manipulation with the hemostatic forceps can lead to tissue trauma around the membranous wall or damage to the voice prosthesis. We present the results of a phase I/II study using a novel atraumatic puncture set for primary and secondary insertion of voice prostheses.Patients and methodsOnce patients had been fully informed and given their consent, the Provox-Vega® puncture set was used in 21xa0patients in either a primary (16) or a secondary (5) procedure. All procedures were documented on video, while approach, complications and surgical success were recorded using a questionnaire.ResultsThe average surgical time was 83.5 (±u200919.12)xa0s for primary voice prosthesis insertion and 212.57 (±u200993.03)xa0s in secondary procedures. The prosthesis could be inserted without complication in 19xa0patients, while a longer prosthesis needed to be selected intraoperatively in two patients due to a thick membranous wall. No serious complications were observed. One patient incurred a discrete injury to the mucosa of the esophageal posterior wall.ConclusionThe Provox-Vega® puncture set proved itself to be a safe aid in the insertion of voice prostheses. It is significantly easier to use than other systems and tissue trauma is minimal. In most cases, no further instruments were required.

Neues Punktionsinstrumentarium: Provox-Vega®-Punktionsset: Anwendung beim Einbringen einer Stimmprothese nach Laryngektomie

BACKGROUNDnThe use of voice prostheses has been considered the gold standard in voice rehabilitation following laryngectomy for the last 20xa0years. Insertion is generally performed as a primary procedure during laryngectomy or as a secondary procedure with a re-usable trocar or rigid esophagoscope, a guidewire and anatomic hemostatic forceps. The use of these instruments requires a certain level of experience on the one hand, while on the other use of a trocar and subsequent manipulation with the hemostatic forceps can lead to tissue trauma around the membranous wall or damage to the voice prosthesis. We present the results of a phase I/II study using a novel atraumatic puncture set for primary and secondary insertion of voice prostheses.nnnPATIENTS AND METHODSnOnce patients had been fully informed and given their consent, the Provox-Vega® puncture set was used in 21xa0patients in either a primary (16) or a secondary (5) procedure. All procedures were documented on video, while approach, complications and surgical success were recorded using a questionnaire.nnnRESULTSnThe average surgical time was 83.5 (±u200919.12)xa0s for primary voice prosthesis insertion and 212.57 (±u200993.03)xa0s in secondary procedures. The prosthesis could be inserted without complication in 19xa0patients, while a longer prosthesis needed to be selected intraoperatively in two patients due to a thick membranous wall. No serious complications were observed. One patient incurred a discrete injury to the mucosa of the esophageal posterior wall.nnnCONCLUSIONnThe Provox-Vega® puncture set proved itself to be a safe aid in the insertion of voice prostheses. It is significantly easier to use than other systems and tissue trauma is minimal. In most cases, no further instruments were required.ZusammenfassungHintergrundDie Verwendung von Stimmprothesen gilt seit etwa 20 Jahren als Goldstandard in der Stimmrehabilitation nach totaler Laryngektomie. Die Versorgung erfolgt in der Regel als primäre Anlage im Rahmen der Laryngektomie oder als sekundäre Anlage im Intervall mit einem wiederverwendbaren Trokar oder starren Ösophagoskop, einem Führungsdraht und anatomischen Gefäßklemmen. Der Einsatz dieses Instrumentariums erfordert zum einen eine gewisse Übung, zum anderen kann es durch die Verwendung des Trokars und die nachfolgende Manipulation mit den Gefäßklemmen zu einer Traumatisierung des Gewebes im Bereich des Paries membranaceus bzw. zu Beschädigungen der Stimmprothese kommen. Wir stellen die Ergebnisse einer Phase-I/II-Studie bei Verwendung eines neuen atraumatischen Punktionssets zur primären und sekundären Stimmprothesenanlage vor.Patienten und MethodenBei 21 Patienten erfolgte nach Aufklärung und Unterschrift die Verwendung des Provox-Vega®-Punktionssets im Rahmen der primären (16) oder sekundären (5) Stimmprothesenanlage. Bei allen Prozeduren wurde die Op. videodokumentiert und mittels eines Fragebogens Handhabung, Komplikationen und Op.-Erfolg erfasst.ErgebnisseDie durchschnittliche Op.-Dauer lag bei primären Stimmprothesenanlagen bei 83,5 (±u200919,12)xa0s, bei sekundären Anlagen bei 212,57 (±u200993,03)xa0s. Bei 19 Patienten konnte die Prothese problemlos eingebracht werden, bei 2xa0Patienten musste im Eingriff wegen eines verdickten Paries membranaceus auf eine längere Prothese gewechselt werden. Schwerwiegende Komplikationen wurden in keinem Fall beobachtet. Bei einem Patienten kam es im Rahmen der Sekundärpunktion zu einer diskreten Verletzung der Schleimhaut der Ösophagushinterwand.SchlussfolgerungDas Provox-Vega®-Punktionsset hat sich im Rahmen der Studie als sicheres Hilfsmittel zur Stimmprothesenanlage bewährt. Die Handhabung ist gegenüber anderen Systemen deutlich vereinfacht, eine Traumatisierung des Gewebes wird minimiert. In den meisten Fällen ist kein weiteres Instrumentarium notwendig.AbstractBackgroundThe use of voice prostheses has been considered the gold standard in voice rehabilitation following laryngectomy for the last 20xa0years. Insertion is generally performed as a primary procedure during laryngectomy or as a secondary procedure with a re-usable trocar or rigid esophagoscope, a guidewire and anatomic hemostatic forceps. The use of these instruments requires a certain level of experience on the one hand, while on the other use of a trocar and subsequent manipulation with the hemostatic forceps can lead to tissue trauma around the membranous wall or damage to the voice prosthesis. We present the results of a phase I/II study using a novel atraumatic puncture set for primary and secondary insertion of voice prostheses.Patients and methodsOnce patients had been fully informed and given their consent, the Provox-Vega® puncture set was used in 21xa0patients in either a primary (16) or a secondary (5) procedure. All procedures were documented on video, while approach, complications and surgical success were recorded using a questionnaire.ResultsThe average surgical time was 83.5 (±u200919.12)xa0s for primary voice prosthesis insertion and 212.57 (±u200993.03)xa0s in secondary procedures. The prosthesis could be inserted without complication in 19xa0patients, while a longer prosthesis needed to be selected intraoperatively in two patients due to a thick membranous wall. No serious complications were observed. One patient incurred a discrete injury to the mucosa of the esophageal posterior wall.ConclusionThe Provox-Vega® puncture set proved itself to be a safe aid in the insertion of voice prostheses. It is significantly easier to use than other systems and tissue trauma is minimal. In most cases, no further instruments were required.

The action of physalaemin on electrolyte secretion by the mandibular and sublingual salivary glands of the rat@@@Der Einflu von Physalaemin auf die Elektrolyt-Sekretion der Submandibularis- und Sublingualisdrse bei der Ratte

ZusammenfassungDer Einfluß von Physalaemin und Acetylcholin auf den Wasser- und Elektrolyttransport wurde am Beispiel der Submandibularis- und Sublingualisdrüse der Ratte untersucht.Nach Stimulation mit Physalaemin fanden sich signifikant niedrigere Na+- und K+-Werte als vergleichsweise im acetylcholinstimulierten Speichel. Diese Befunde stimmen mit vorausgegangenen Mikroperfusionsstudien an der Submandibularis der Ratte überein. Letztere demonstrierten eine Stimulation der Na+-Reabsorption und Hemmung der Kaliumsekretion durch Physalaemin, während Acetylcholin einen entgegengesetzten Effekt zeigte.SummaryThe effects of physalaemin and acetylcholine on fluid and electrolyte excretion by the mandibular and sublingual glands of the rat were examined. Physalaemin-evoked mandibular and sublingual saliva was found to be poorer in sodium and potassium than acetylcholine-evoked saliva. These findings agree well with previous findings in the isolated perfused main excretory duct where physalaemin stimulates sodium reabsorption and inhibits potassium secretion, whereas acetylcholine has the opposite effect.