Rainer Kubiak’s research while affiliated with University of Mannheim and other places

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Publications (28)


Feasibility and Challenges of Pyeloureteral Magnetic Anastomosis Device in Domestic Pigs: A Stepwise Approach with Extended Observation
  • Article

January 2025

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11 Reads

European Journal of Pediatric Surgery

Rainer Kubiak

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Zita Hornok

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[...]

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Tamas Cserni

Objective The pyeloureteral anastomosis remains the most challenging part of pyeloplasty. A purpose-built anastomotic device could simplify this step and potentially improve outcomes. The concept of a pyeloureteral magnetic anastomosis device (PUMA) was proven in minipigs, but only in short term. Our aim was to test the PUMA in domestic pigs and achieve a prolonged follow-up period. Methods Five female domestic pigs underwent laparoscopy and ligation of the left ureter. Four weeks later, laparoscopic implantation of the PUMA was planned. Removal of the device and a retrograde contrast study were scheduled after another 4 weeks. The experiment was terminated when the animals could no longer be properly cared for due to their weight. Results Due to unexpected smaller ureteric diameters, a modified PUMA could only be successfully inserted in pig number 3 (49 kg). Four weeks later, the device was found to be dislocated, but the anastomosis remained patent. After modifying the study protocol, the PUMA was successfully implanted in pigs number 4 (96 kg) and 5 (68 kg) 8 weeks after ureteric ligation. Pig 4 developed malignant hyperthermia and died. In pig 5, the magnets were removed 4 weeks later. After an additional 8 weeks, the animal reached 135 kg and was terminated. The anastomosis remained patent and preserved its diameter. Conclusion Despite limitations, our study successfully demonstrated that the PUMA can achieve a patent ureteric anastomosis in domestic pigs. This suggests a potential for minimally invasive ureteric anastomosis in clinical settings. Further research is needed to optimize the technique and validate its effectiveness in humans.


Cheap and clean dry balloon training model for laparoscopic pyeloplasty

March 2023

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17 Reads

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6 Citations

Journal of Pediatric Urology

Simulation-based training (SBT) has a significant role in training in complex procedure like laparoscopic pyeloplasty. We propose a new training model for laparoscopic pyeloplasty which has been compared to other models. Trainees (n = 22) evaluated our balloon model (BM) and three other models -glove finger model (GFM), chicken thigh model (ChTM) and chicken crop model (ChCrM)- subjectively, based on a 5-point Likert scale. The face validity mean score of our BM model was 3.58 ± 0.69. Our novel model can be a cost-effective, hygienic, and easy-access alternative to other laparoscopic pyeloplasty models.


Esophageal Magnetic Anastomosis Device (EMAD) to Simplify and Improve Outcome of Thoracoscopic Repair for Esophageal Atresia with Tracheoesophageal Fistula: A Proof of Concept Study

October 2022

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52 Reads

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5 Citations

Journal of Pediatric Surgery

Background We designed a new Esophageal Magnetic Anastomosis Device (EMAD) for thoracoscopic repair of esophageal atresia (EA) with tracheoesophageal fistula (TEF) without the need of handheld suturing or additional gastrostomy. Methods Synthetic EA-TEF model: Spherical and tubular shaped rubber balloons and a term infant sized plastic doll were used. Medical students (n=10) and surgical trainees (n=10) were asked to perform thoracoscopic repair of an „EA” with a hand sutured anastomosis (HA) and with the EMAD. Euthanized animal model: The esophagus in 5 piglets (3-4 kg) was dissected and a thoracoscopic esophageal magnetic anastomosis (EMA) was performed. Bursting pressure (BP) and pulling force (PF): HA and EMA were created on ex vivo New Zealand white rabbit (2.5-3 kg) esophagi (n=25 in each test series). BP and PF were measured and compared against each other. Results Medical students were unable to complete HA, but were successful with the EMAD in 11.1±2.78 min. Surgical trainees completed EMA in 4.6±2.06 min vs. HA 30.8±4.29 min (p<0.001). The BP following a HA (14.1±3.32 cmH2O) was close to the physiological intraluminal pressure reported in a neonatal esophagus (around 20 cmH2O), whereas the BP with the EMAD was extremely high (>90 cmH2O) (p<0.001). The PF of an EMA (1.8±0.30 N) was closer to the safety limits of anastomotic tension reported in the literature (i.e. 0.75 N) compared with the HA (3.6±0.43 N) (p<0.0001). Conclusion The EMAD could simplify, shorten, and potentially improve the outcome of thoracoscopic repair for EA with TEF in the future. A high BS and a relative low PF following EMAD application may lower the risk of postoperative complications such as esophageal leakage and stricture formation.


10 Year Follow-Up of Randomized Trial of Laparoscopic Nissen Versus Thal Fundoplication in Children

September 2022

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18 Reads

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1 Citation

Journal of Laparoendoscopic & Advanced Surgical Techniques

Introduction: The aim of this study was to compare the long-term outcomes of laparoscopic complete (Nissen) fundoplication (LNF) with laparoscopic partial (Thal) fundoplication (LTF) in children. This is the only prospective, randomized study to follow patients up for more than 10 years. Interim results published in 2011 at median 2.5 year follow-up showed that LNF had a significantly lower failure rate compared with LTF. Materials and Methods: A randomized, controlled trial of LNF versus LTF in children (<16 years) was performed. The primary outcome measure was "absolute" failure of the fundoplication-recurrence of symptoms that merited either reoperation or insertion of transgastric jejunostomy (GJ). Secondary outcomes were "relative" failure (need for postop antireflux medication), complications (e.g., dysphagia), and death. Results: One hundred seventy-five patients were recruited; 89 underwent LNF, and 86 underwent LTF. Eight patients had no follow-up recorded. At long-term follow-up, 59 patients had died (35%); LNF 37/85 (43.5%) and LTF 22/82 (26.8%), P = .02. Median length of follow-up in survivors was 132 months. There was no statistically significant difference in "absolute" failure rate between LNF 8/85(9.4%) and LTF 15/82 (18%), P = .14. There was no difference in "relative" failure between LNF 7/85 (8.2%) and LTF 12/82 (14%), P = .23. Long-term dysphagia affected 5 out of 108 (4.6%) patients; 3/48 (6.2%) of LNF and 2/60 (3.3%) of LTF (P = .65). Conclusions: There was no statistically significant difference in 'absolute' failure between LNF and LTF at long-term follow-up. Neurologically impaired children have a high mortality rate following fundoplication due to comorbidities. This trial commenced in 1998 and was approved by the Oxfordshire Research Ethics Committee (No. 04.OXA.18-1998).


Pyeloureteric magnetic anastomosis device to simplify laparoscopic pyeloplasty: a proof‐of‐concept study
  • Article
  • Full-text available

January 2021

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335 Reads

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3 Citations

Laparoscopic pyeloplasty (LP) is a standard, but demanding operation. According to the European Association of Urology guidelines this procedure scores 13 out of 18 on the difficulty scale [1]. Articulating instruments, 3D video systems and robots may facilitate complex suturing of the ureteropelvic anastomosis at higher costs [2,3]. Magnetic compression anastomosis (magnamosis) has been used safely and effectively in the gastrointestinal tract [4,5], however not been applied in the urinary tract.

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Experience with Fully Covered Self-Expandable Metal Stents for Esophageal Leakage in Children

October 2019

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14 Reads

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3 Citations

Klinische Pädiatrie

Background There is a lack of experience with fully covered self-expandable metal stents (SEMSs) for the treatment of esophageal leakage particularly in infants and neonates. Methods Eight patients (5M, 3F) with a median age of 17 months (range, 1–135 months) who underwent treatment with SEMSs for an anastomotic leakage or perforation of the esophagus were recruited to this retrospective study. Four children were born premature. In six patients the stents were placed primarily as an emergency procedure. Results Median duration of individual stent placement was 42 days (range, 13–72 days). Six out of eight patients (75%) were treated with one stent only. In three preterm infants who had their stents inserted within the first month relative weight gain was 17% compared with 2% in five patients who were treated later in life (p=0.0986). In four cases (50%) distal migration of the stent was observed. Seven out of eight patients (88%) had their leakage resolved after stent therapy. Conclusions Insertion of fully covered SEMSs is an alternative tool for the treatment of esophageal leakage in children and preterm infants, and successful with only one single application in selected cases. It can be used either following previous therapy or as part of an emergency procedure. Because of the absence of manufactured, age-related devices SEMSs that are originally designed for other organs can be applied.


Figure 4. K-wire fixation of the radius with one pin inserted transepiphyseal intramedullary. K-wire = Kirschner wire.
Figure 5. Radial ESIN without sufficient pre-bending of the nail leading to a deviation of the distal fragment with a cosmetically unsatisfactory aspect of the wrist. Of note, forearm function was without limitation at last follow-up. ESIN = elastic stable intramedullary nailing.
Characteristics and outcome in patients with complications in the course of treatment.
Is there a standard treatment for displaced pediatric diametaphyseal forearm fractures?: A STROBE-compliant retrospective study

July 2019

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2,200 Reads

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17 Citations

Medicine

To review our institutional results and assess different surgical and non-surgical techniques for the treatment of displaced diametaphyseal forearm fractures in children and adolescents. Thirty-four children (25M, 9F) with a total of 36 diametaphyseal forearm fractures who underwent treatment under general anesthesia between July 2010 and February 2016 were recruited to this retrospective study. From October 2016 until March 2018 patients and/or parents were contacted by telephone and interviewed using a modified Pediatric Outcomes Data Collection Instrument (PODCI). Median age at the time of injury was 9.1 years (range, 1.9–14.6 years). Initial treatment included manipulation under anesthesia (MUA) and application of plaster of Paris (POP) (n = 9), elastic stable intramedullary nailing (ESIN) (n = 10), percutaneous insertion of at least one Kirschner wire (K-wire) (n = 16), and application of external fixation (n = 1). Eleven children (32%) experienced a total of 22 complications. Seven complications were considered as major, including delayed union (n = 1) and extensor pollicis longus (EPL) tendon injury (n = 1) following ESIN, as well as loss of reduction (n = 2) and refractures (n = 3) after MUA/POP. The median follow-up time was 28.8 months (range, 5.3–85.8 months). In 32 out of 34 cases (94%) patients and/or parents were contacted by telephone and a PODCI score was obtained. Patients who experienced complications in the course of treatment had a significantly lower score compared with those whose fracture healed without any sequelae (P = .001). There was a trend towards an unfavorable outcome following ESIN compared with K-wire fixation (P = .063), but not compared with POP (P = .553). No statistical significance was observed between children who were treated initially with a POP and those who had K-wire fixation (P = .216). There is no standard treatment for displaced pediatric diametaphyseal forearm fractures. Management with MUA/POP only is associated with an increased refracture rate. Based on our experience K-wire fixation including intramedullar positioning of at least one pin seems to be favorable compared with ESIN.


Experience with Stent Placement for Benign Pancreaticobiliary Disorders in Children

April 2019

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54 Reads

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2 Citations

Journal of Laparoendoscopic & Advanced Surgical Techniques

Purpose: There is a lack of experience with stenting for benign pancreaticobiliary disorders in children. Materials and Methods: Fifteen children (9 male and 6 female) with a median age of 7.1 years (range 0.7-14.2 years) who underwent treatment with a plastic stent for a benign disorder of the pancreaticobiliary system between May 2003 and September 2017 were recruited to this retrospective study. Results: Biliary and/or pancreatic plastic stents were inserted into 5 patients with congenital, 4 with post-traumatic, and 6 with idiopathic pathologies. Median duration of individual stent placement was 111 days (range 14-1569 days). Eleven children (73%) were treated with one stent only. In 4 cases, up to 22 stents were successively placed over time. There were no complications during stent insertion or stent removal. Seven patients (47%) experienced adverse effects during stenting, including choledocholithiasis, pancreaticolithiasis, cholangitis, acute pancreatitis, stent obstruction, and stent fracture. At follow-up, in 11 cases (73%), the underlying condition was resolved. In 4 children, all of whom suffered from congenital pancreaticobiliary disorders, stent therapy was considered as a temporary treatment before definite surgery. Conclusions: Patients with congenital anomalies of the pancreaticobiliary tree often require surgery for definitive management. However, temporary stent placement can be accomplished safely and successfully and this serves as a bridge to temporize their obstructive process while awaiting surgical intervention. Children with post-traumatic or idiopathic disorders can frequently be managed definitively by stenting alone and many of these require only one single stent insertion.


Experience with fully covered self-expandable metal stents for anastomotic stricture following esophageal atresia repair

June 2018

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17 Reads

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14 Citations

Diseases of the Esophagus

There is a lack of experience with fully covered self-expandable metal stents (SEMSs) for the treatment of benign esophageal conditions in the pediatric population. This is the evaluation of our institutional experience of placing SEMSs for anastomotic stricture (AS) formation following esophageal atresia (EA) repair. Patients were jointly managed from the Department of Pediatric Surgery and Central Interdisciplinary Endoscopy at our institution. Thirteen children (8 male, 5 female) with a median age of 4 months (range: 1–32 months) who underwent treatment with SEMSs for a postoperative AS following EA repair between February 2006 and April 2016 were recruited into this retrospective study. SEMSs that are originally designed for other organs such as trachea, bronchus, biliary tract, or colon were inserted under general anesthesia via endoscopic guidance. Simultaneous fluoroscopy was not required in any case. In five infants, the stents were inserted primarily without previous therapy. Seven patients underwent stenting following dilatation with or without adjuncts (e.g. Mitomycin C, Triamcinolone). In one case with an AS and a simultaneous persistent tracheoesophageal fistula (TEF), multiple SEMSs were applied after failure to close the fistula with fibrin glue. The median duration of individual stent placement was 30 days (range: 5–91 days). In five children up to four different biliary, bronchial or colonic SEMSs were placed successively over time. There were no problems noted at stent insertion or removal. Eight children (62%) developed complications associated with stenting. At follow-up, in eight patients (62%) AS was resolved, including all of those five cases, who had their stents inserted without previous therapy. Five children (38%), who underwent dilatation prior to stenting did not improve their AS and required further intervention. Overall, the cohort exhibited a slight, but not significant weight gain between stent insertion and (final) stent removal. Insertion of SEMSs for AS following EA repair is safe and often successful with only one single application. It can be used as a primary procedure (without previous therapy) or after failed dilatations. There was one death in this study that was unrelated to stenting and occurred 12 months after stent removal. Because of the absence of manufactured, age-related devices, SEMSs that are originally designed for other organs can be applied. Establishment of a standardized management including stent placement for the treatment of AS following EA repair in the pediatric population is required.


Percutaneous collagen induction as an additive treatment for scar formation following thermal injuries: Preliminary experience in 47 children

March 2017

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63 Reads

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24 Citations

Burns

Background: Thermal injuries are one of the most physically and psychologically devastating causes of pediatric trauma. Post-traumatic sequelae such as hypertrophic scars and contractures often result in long lasting morbidity and disfigurement. Conservative therapy, including pressure garments and silicone, is the gold standard for scar management in the pediatric population. Most recently percutaneous collagen induction (PCI) was introduced as an alternative treatment in adults. The aim of this report was to share our experience with PCI in children and adolescents in scar management following thermal injuries. Patients and methods: Between July 2013 and February 2016, a total of 99 PCI treatments were performed on forty-seven children and adolescents for scar formation following thermal injuries in this retrospective study. A medical roller device (Dermaroller(®), Dermaroller GmbH, Wolfenbüttel, Germany) with 2.5mm long needles was used. All procedures were carried out under general anesthesia. At the end of the operation vitamin A and vitamin C oil (ENVIRON(®) AVST Body Oil; Environ Skin Care, Pty. Ltd., Cape Town, South Africa) was applied topically. Photographs were taken before and a minimum of 4 weeks after the first PCI in order to document the effect on scar tissue. These images were graded according to the Vancouver Scar Scale (VSS). Results: The median age at the time of the first PCI was 8.3 years (range, 0.8-21.2 years). The median time interval between the injury and PCI was 18 months (range, 4-170 months). There were no intraoperative problems noted. Minor postoperative complications occurred in 2 patients (4.3%). All patients reported subjective improvement and were satisfied with the procedure and the results. Pre- and post-treatment photographs were available in 40 patients, and overall VSS scores improved post-treatment in all patients. Following a single PCI treatment, scar vascularity, pliability and height all improved, however there was no statistically significant effect on pigmentation. Conclusions: PCI is an enrichment of the armamentarium for scar treatment following thermal injuries in children and adolescents. Further prospective studies are recommended regarding the optimal timing for this treatment and long term outcome in the pediatric population.


Citations (25)


... Several surgical specialties are employing training using surgical simulators beyond the confines of the operating room. For instance, there is widespread acknowledgment that simulators serve as effective educational aids and enable the assessment of technical proficiency in laparoscopic surgery [3][4][5]. ...

Reference:

Validation of A 3D-printed simulator for training in endoscopic injection of bulking agent for vesicoureteral reflux: a pilot study
Cheap and clean dry balloon training model for laparoscopic pyeloplasty
  • Citing Article
  • March 2023

Journal of Pediatric Urology

... A significant proportion of children develop musculoskeletal deformities after thoracotomy, but most of them are subclinical. An axillary muscle-sparing technique has been shown to significantly decrease the incidence of these deformities [6][7][8][9][10]. Other complications (leakage, dehiscence, stenosis…) are not directly related to the surgical approach, but are influenced by factors such as the type of EA, patient characteristics and technical details. ...

Esophageal Magnetic Anastomosis Device (EMAD) to Simplify and Improve Outcome of Thoracoscopic Repair for Esophageal Atresia with Tracheoesophageal Fistula: A Proof of Concept Study
  • Citing Article
  • October 2022

Journal of Pediatric Surgery

... Kubiak and colleagues conducted a prospective study involving 175 patients and reported a considerably higher incidence of dysphagia at 11.8% when a complete wrap was performed. However, it is worth noting that other studies have not found any significant relationship between dysphagia and the type of wrap used (15) . ...

10 Year Follow-Up of Randomized Trial of Laparoscopic Nissen Versus Thal Fundoplication in Children
  • Citing Article
  • September 2022

Journal of Laparoendoscopic & Advanced Surgical Techniques

... Most recently, our group reported on the pyeloureteral magnetic anastomosis (PUMA) device with a unique delivery system, which significantly simplifies laparoscopic pyeloplasty in an experimental setting [7] . Based on the PUMA concept, this paper reports our technique of performing a one-stage procedurethoracoscopy for ligation of fistula and simultaneous insertion of magnets together with a transanastomotic feeding tube. ...

Pyeloureteric magnetic anastomosis device to simplify laparoscopic pyeloplasty: a proof‐of‐concept study

... Most of the devices that have fractured and/or migrated are either tracheostomy tubes 44,45 or oesophageal stents. 46 To the best of our knowledge, we document the first case of a fractured and migrated gastrostomy tube component into the cervical oesophagus (Figure 18a and b). It is important for radiologists to recognise and immediately report such complications to prevent unwarranted complications. ...

Experience with Fully Covered Self-Expandable Metal Stents for Esophageal Leakage in Children
  • Citing Article
  • October 2019

Klinische Pädiatrie

... Unstable diametaphyseal radius fractures (DMRFs) are a matter of great interest to pediatric surgeons. Loss of reduction, refractures, and limited remodeling can make the treatment challenging [7][8][9][10]. The AO Pediatric Comprehensive Classification of Long Bone Fractures (PCCF) disregards fractures within the DMJZ as an own entity. ...

Is there a standard treatment for displaced pediatric diametaphyseal forearm fractures?: A STROBE-compliant retrospective study

Medicine

... There is a lack of experience with stenting of benign pancreatic biliary disorders in children. However, temporary stent placement can be accomplished safely and successfully, and this serves as a bridging therapy while awaiting surgical intervention [106]. ...

Experience with Stent Placement for Benign Pancreaticobiliary Disorders in Children
  • Citing Article
  • April 2019

Journal of Laparoendoscopic & Advanced Surgical Techniques

... This reduction may be attributed to a shorter median stent retention duration, regular monitoring of stent position via chest X-rays, the preference for longer stents, and avoiding placement across the lower esophageal sphincter [48]. Manfredi [51] demonstrated that FCSEMS placement is both safe and often successful with a single application in patients with AS following EA repair. Nevertheless, patient tolerance remains suboptimal, and complications such as migration persist. ...

Experience with fully covered self-expandable metal stents for anastomotic stricture following esophageal atresia repair
  • Citing Article
  • June 2018

Diseases of the Esophagus

... While mortality rates among burn patients have decreased over recent decades due to advancements in treatment and knowledge, post-traumatic complications such as hypertrophic scars (HTSs), keloid formation and contractures often result in long-term discomfort and functional deficits. 1 Scars and burn injuries have significant impacts on patients' lives and the healthcare system. 2 HTSs develop when the natural healing process is disrupted, characterized by increased inflammation and excessive collagen accumulation, leading to prominent, hard, itchy, painful and erythematous lesions. 3 Various treatment methods are employed to manage HTSs, including silicone or hydrogel sheets, compression therapy, ultrasound, surgical incision, tissue expansion, intralesional steroids, chemotherapy with interferon injections, cryotherapy, radiation therapy and photothermolysis. ...

Percutaneous collagen induction as an additive treatment for scar formation following thermal injuries: Preliminary experience in 47 children
  • Citing Article
  • March 2017

Burns

... 2,3,6 A case report exists of an infant in whom a removable silicone stent was successfully placed for a benign anastomotic stricture following surgery for Hirschsprung's disease. 8 In a case series of five patients, Lange et al. 9 describe the use of metallic stents for benign colorectal strictures with 10 who used SEMS for relieving complete large bowel malignant obstruction in a child. Similarly, due to its rarity, no definitive treatment has been proposed for children with malignant colorectal tumours and the few case reports which do exist suggest using adult chemotherapy protocols in children presenting with CRC. ...

Use of covered self-expandable stents for benign colorectal disorders in children
  • Citing Article
  • March 2016

Journal of Pediatric Surgery