Clinical Newsletter
Regular updates on our latest clinical studies.
Onze teams van Onderzoek en Ontwikkeling zijn wereldwijd werkzaam, en creëren synergieën met onze deskundigheid en verwante vakdisciplines. Wij wisselen internationaal veel van gedachten met onafhankelijke, gespecialiseerde instituten, belangrijke opinieleiders en kennisverspreiders om zo samenwerkings- en kennismanagement op het hoogste niveau te kunnen garanderen. In het kader daarvan voeren wij grote studies uit die voortdurend op congressen in de vorm van posters of lezingen van onze partners, op symposia en in workshops worden gepresenteerd, en ook in befaamde wetenschappelijke tijdschriften worden gepubliceerd. De voor het grootste deel door onafhankelijke deskundigen beoordeelde, op bewijs gebaseerde vakpublicaties stellen wij u graag in deze databank ter beschikking:
The objective of this study is to compare the effectiveness, comfort and possibilities of the self-application of adjustable compression wraps (ACW) with compression bandaging (CB) in the acute phase of treatment in advanced upper-limb lymphedema. In total, 36 patients who fulfilled the admission criteria were randomly assigned into ACW-Group (18 patients), or CB-Group (18 patients). Treatment in both groups lasted for two weeks. In the first, all patients were educated in applying adjustable compression wraps (ACW-Group) or self-bandaging (CB-Group) and treated by experienced physiotherapists. In the second week, the use of ACW and CB was continued by the patients themselves at home. In both groups, a clinically significant reduction in the affected limb volume was found after the first week (p < 0.001). A further decrease in the affected limb volume within the second week was noted only in the CB-Group (p = 0.02). A parallel trend was found in the percentage reduction in the excess volume after one and two weeks of compression therapy. Within two weeks, both groups achieved a significant improvement in decreasing lymphedema-related symptoms, but women from the ACW-Group reported complications related to carrying out compression more frequently (p = 0.002). ACW can reduce lymphedema and disease-related symptoms, but based on the results it is difficult to recommend this method as an alternative option in the acute phase of CPT among women with advanced arm lymphedema.
INTRODUCTION
Early postoperative reflux (PR) can compromise anastomotic healing after Ivor Lewis esophagectomy (ILE) and poses a risk for aspiration. Anastomotic insufficiency is the most threatening surgical complication. We present the protective method of pre-emptive active reflux drainage (PARD) with simultaneous enteral feeding. We report our experience with this new safety concept in esophageal surgery in a cohort of 43 patients.
MATERIALS AND METHODS
For PARD we use a double lumen open porous film drainage (dOFD). To create the dOFD, the gastric tube of a Trelumina probe (Freka®Trelumina, Fresenius) is coated with a double-layered open-pore drainage film (Suprasorb®CNP drainage film, Lohmann & Rauscher) over a length of 25 cm. The dOFD is endoscopically inserted into the tubular stomach intraoperatively after completion of the anastomosis. Continuous negative pressure is applied with an electronic pump (-125 mm Hg). The PR is continuously aspirated completely and the stomach and anastomotic region are decompressed. At the same time, nutrition is delivered via an integrated intestinal tube. Depending on the results of the endoscopic control after 5 days, PARD is either continued or terminated.
RESULTS
During the observation period (2017-2023), PARD was used in all patients (n = 43) with ILE. The healing rate under PARD was 100% and healing was observed in all anastomoses. No additional endoscopic procedures or surgical revisions of the anastomoses were required. The median duration of PARD was 8 days (range 4-21). We observed problems in the healing of the anastomosis in 20 of 43 patients (47%) for whom we defined endoscopic criteria for at-risk anastomosis.
CONCLUSIONS
Our results suggest that PARD has a strong protective effect on anastomotic healing and may reduce the risk of anastomotic insufficiency. The integrated feeding tube of the dOFD allows early postoperative enteral feeding while simultaneously applying negative pressure. PARD appears to prevent the negative consequences of impaired anastomotic healing.
ZUSAMMENFASSUNG
EINLEITUNG: Der früh postoperative Reflux (PR) kann die Anastomosenheilung nach Ivor-Lewis-Ösophagektomie (ILE) beeinträchtigen und stellt ein Risiko für Aspirationen dar. Die Anastomoseninsuffizienz ist die bedrohlichste chirurgische Komplikation.Wir stellen die protektive Methode der pre-emptiven aktiven Refluxdrainage (PARD) mit gleichzeitiger enteraler Ernährung vor. Wir berichten über unsere Erfahrungen mit dem neuen Sicherheitskonzept für die Ösophaguschirurgie an einem Patientenkollektiv von 43 Patienten.
MATERIALIEN UND METHODEN
Zur PARD nutzen wir eine doppellumige offenporige Foliendrainage (dOFD). Zur Herstellung der dOFD wird der gastrale Schenkel einer Trelumina Sonde (Freka®Trelumina, Fresenius) über eine Länge von 25 cm mit einer doppellagigen offenporigen Drainagefolie (Suprasorb®CNP Drainagefolie, Lohmann & Rauscher) beschichtet. Die dOFD wird nach Fertigstellung der Anastomose intraoperativ endoskopisch im Schlauchmagen eingeführt. Es wird ein kontinuierlicher Unterdruck mit einer elektronischen Pumpe angelegt (−125 mm Hg). Der PR wird permanent komplett abgesaugt, der Magen und die Anastomosenregion dekomprimiert. Gleichzeitig wird über eine integrierte Intestinalsonde ernährt. Je nach den Ergebnissen der endoskopischen Kontrolle nach 5 Tagen wird PARD entweder fortgesetzt oder beendet.
ERGEBNISSE
Im Beobachtungszeitraum (2017–2023) wurde PARD bei allen Patienten (n = 43) mit ILE eingesetzt. Die Heilungsrate unter PARD betrug 100 %, bei allen Anastomosen wurde eine Abheilung beobachtet. Es wurden keine zusätzlichen endoskopischen Eingriffe oder chirurgische Revisionen an den Anastomosen erforderlich. Die mediane Dauer der PARD betrug 8 Tage (Spanne 4–21). Bei 20 von 43 Patienten (47 %) sahen wir Probleme in der Anastomosenheilung, für die wir endoskopische Kriterien der Risikoanastomose definierten.
SCHLUSSFOLGERUNG
Unsere Ergebnisse legen nahe, dass PARD einen starken protektiven Effekt auf die Anastomosenheilung hat und das Risiko der Anastomoseninsuffizienz reduzieren kann. Die integrierte Ernährungssonde der dOFD ermöglicht simultan zur Unterdruckausübung die frühpostoperative enterale Ernährung. PARD scheint die negativen Folgen einer gestörten Anastomosenheilung zu verhindern.
BACKGROUND
Endoscopic vacuum therapy (EVT) is an increasingly popular endoscopic technique used for the treatment of wall defects in the gastrointestinal tract. Open-pore film drainage (OFD) systems are a new addition to the armamentarium of EVT and have shown encouraging results in a wide spectrum of applications. The aim of this review is to summarize the current literature on the applications of OFD systems in the gastrointestinal tract.
SUMMARY
Open-pore film drainage (OFD) systems have been used for the treatment of several defects of the gastrointestinal tract. The small size and easy placement of these devices make them very useful, particularly for the treatment of defects that are small in size or difficult to reach. OFDs have been successfully used for both perforations and anastomotic leaks in various locations, with most reports focusing on the treatment of duodenal defects, although successful applications in the esophagus, stomach, and colon have also been reported. Lately, the role of OFDs in preemptive EVT has also been explored.
KEY MESSAGES
OFD systems are easy to use, particularly for small defects and challenging localizations. The current literature, consisting mainly of small case series and case reports, shows encouraging results, but further prospective studies are needed to explore and verify the indications and technical aspects of this innovative method.
Endoscopic vacuum therapy (EVT) is an increasingly popular treatment option for wall defects in the upper gastrointestinal tract. After its initial description for the treatment of anastomotic leaks after esophageal and gastric surgery, it was also implemented for a wide range of defects, including acute perforations, duodenal lesions, and postbariatric complications. Apart from the initially proposed handmade sponge inserted using the "piggyback" technique, further devices were used, such as the commercially available EsoSponge and VAC-Stent as well as open-pore film drainage. The reported pressure settings and intervals between the subsequent endoscopic procedures vary greatly, but all available evidence highlights the efficacy of EVT, with high success rates and low morbidity and mortality, so that in many centers it is considered to be a first-line treatment, especially for anastomotic leaks.
Lymphedema secondary to breast cancer is a chronic condition that requires continuous care to control the volume of the affected limb, with compression therapy as the main treatment. The self-adjusting compressive wrap is a new option, whose main advantage is the fact that it is put on by the patient himself. The aim of this study was to describe the use of self-adjusting clothing as an alternative to reduce the volume of the upper limb of a patient with breast cancer-related lymphedema. This study was part of the study adjustable garment compression therapy (ReadyWrap®) in lymphedema secondary to breast cancer: a randomized clinical trial, approved by the CEP/INCA under opinion 4.611.711 and registered in the Clinical Trials under no. NCT04934098. The patient was evaluated before and after the 30-day intervention using physical examination (e.g., inspection, palpation, and perimetry). Skin tissue characteristics were collected using a thermographic camera, while the health-related quality of life (HRQoL) was assessed by answering the EORTC-QLQ C30 questionnaire. As an intervention, an adjustable garment (ReadyWrap®) was used for 30 days. An absolute reduction of 612.47 mL (61.1%) was observed, and at the end of this period, the difference of 21.5% in excess volume compared with the volume of the contralateral limb was maintained. Regarding the tissue characteristics of the skin, there was an increase in the minimum temperature in the affected upper limb, which reached 31.8°C, against 31.2°C in the contralateral limb, with ∆T=0.6°C. Compressive therapy by adjustable garment (ReadyWrap®) demonstrated a 61.1% reduction in the volume of the upper limb with breast cancer-related lymphedema in 30 days of use.
Hiraï a mis au point un dispositif permettant d’évaluer les performances in vitro de différents systèmes de compression.
L’étude de sept bandages (Biflex 16, Urgo K2, Urgo K1, Coban 2, Biflex kit, Rosidal K et Rosidal Sys) sur la jambe d’Hiraï a permis une analyse précise de l’évolution de leur pression et de leur rigidité.
Ces bandages ont été appliqués avec une pression de 45 ± 2 mmHg au point B1, 100 manœuvres d’étirement ont alors été réalisées.
Une diminution de la moyenne des pressions pré-étirement est plus marquée pour Rosidal K, Urgo K1 et Coban 2 que pour les autres bandages.
Biflex 16 n’est pas un bandage rigide.
Urgo K1, Urgo K2, Coban 2, Kit Biflex ont des rigidités très similaires.
Rosidal K et Rosidal Sys ont une rigidité plus élevée.
Situation
A 65-year-old male bed bound patient with a BMI of 16 kg/m², a schizoid personality disorder, former strong alcoholism and an MCA stroke in 2019 with low rehabilitation potential, was presented with a sacral pressure injury to the District Nursing Service.
Action(s) taken/ treatment provided
The pressure injury was subjected to sharp debridement to remove the hard necrotic tissue. For further autolytic debridement, the wound was treated with a hydrogel wound dressing*. For exudate management, a superabsorbent wound dressing** was used as a secondary association. In the first week, the wound was additionally debrided mechanically. However, since this resulted in more arterial bleeding, treatment completely switched to autolytic debridement. Dressing changes were completed daily by Rest Home staff with weekly input from the District Nurse.
Outcome(s)
After 5 days of autolytic debridement, dark eschar started to soften. Further maceration of the peri wound skin was prevented by the superabsorbent dressing via absorbing high quantities of exudate. After 15 days, the necrotic areas were starting to lift up. Granulation on some areas of the wound bed developed. After 28 days, some edges of the wound bed had partially healed. After 43 days the wound had healed to such an extent that autolytic debridement was no longer indicated and application of a dermal template commenced.
Lesson(s) learned
The hydrogel wound dressing in combination with the superabsorbent dressing were able to debride and prepare the wound bed for the next step of application with a dermal template.