Mobile Dressing Trolleys Improve Satisfaction and Logistics on Pediatric Surgery Wards.

BACKGROUND: Evidence-based data on the effect of dressing trolleys on children's postoperative recovery are not available. The aim of this study was to evaluate a specific pediatric surgical dressing trolley on patient and caregiver satisfaction, as well as temporal and logistical aspects of the dressing change procedures. METHODS: In a prospective observational non-randomized study, a total of 100 dressing changes were observed before (group 1) and after (group 2) the introduction of a pediatric surgical dressing trolley and the satisfaction, time and logistical factors were recorded on site. RESULTS: The median preparation time, the duration of the dressing change and the total time decreased significantly from group 1 to group 2 by 1:11 min (p < 0.001); 1:56 min (p = 0.05) and 5:09 min (p = 0.001), respectively. The patient's room was left significantly less often in group 2 to retrieve missing bandages. The median satisfaction of the medical staff increased by 12% in group 2 (p < 0.001). The satisfaction of the parents increased by 2.5% in group 2 (p = 0.042), and that of the nursing staff increased by 9.25% in group 2 (p = 0.015). CONCLUSIONS: Our results demonstrate the positive effects of a dressing trolley for pediatric surgical dressing changes by minimizing postoperative handling and manipulation of the child. It improves time and logistical factors as well as the satisfaction of those involved, which may lead to a faster recovery.

Evaluation of the Versius Robotic System for Infant Surgery-A Study in Piglets of Less than 10 kg Body Weight.

BACKGROUND: We were able to demonstrate the feasibility of a new robotic system (Versius, CMR Surgical, Cambridge, UK) for procedures in small inanimate cavities. The aim of this consecutive study was to test the Versius® system for its feasibility, performance, and safety of robotic abdominal and thoracic surgery in piglets simulating infants with a body weight lower than 10 kg. METHODS: A total of 24 procedures (from explorative laparoscopy to thoracoscopic esophageal repair) were performed in 4 piglets with a mean age of 12 days and a mean body weight of 6.4 (7-7.5) kg. Additional urological procedures were performed after euthanasia of the piglet. The Versius® robotic system was used with 5 mm wristed instruments and a 10 mm 3D 0° or 30° camera. The setup consisted of the master console and three to four separate arms. The performance of the procedure, the size, position, and the distance between the ports, the external and internal collisions, and complications of the procedures were recorded and analyzed. RESULTS: We were able to perform all surgical procedures as planned. We encountered neither surgical nor robot-associated complications in the live model. Whereas all abdominal procedures could be performed successfully under general anesthesia, one piglet was euthanized early before the thoracic interventions, likely due to pulmonary inflammatory response. Technical limitations were based on the size of the camera (10 mm) being too large and the minimal insertion depth of the instruments for calibration of the fulcrum point. CONCLUSIONS: Robotic surgery on newborns and infants appears technically feasible with the Versius® system. Software adjustments for fulcrum point calibration need to be implemented by the manufacturer as a result of our study. To further evaluate the Versius® system, prospective trials are needed, comparing it to open and laparoscopic surgery as well as to other robotic systems.

Minimally Invasive Bimanual Fetal Surgery-A Review.

BACKGROUND: The aim of this review is to discuss experimental and clinical techniques and interventions of fetal surgery which have been performed minimally invasively by the means of a three-port approach for the fetoscope and instruments for the left and right hand of the surgeon (bimanual minimally invasive fetal surgery). METHODS: a print and electronic literature search was performed; the titles and abstracts were screened and included reports were reviewed in a two-step approach. First, reports other than minimally invasive fetal surgery were excluded, then a full text review and analysis of the reported data was performed. RESULTS: 17 reports were included. The heterogeneity of the included reports was high. Although reports on human fetoscopic surgical procedures can be found, most of them do not pick out bimanual fetal surgery as a central theme but rather address interventions applying a fetoscope with a working channel for a laser fiber, needle or flexible instrument. Most reports were on experimentation in animal models, the human application of minimally invasive fetoscopic bimanual surgery is rare and has at best been explored for the prenatal treatment of spina bifida. Some reported bimanual fetoscopic procedures were performed on the exteriorized uterus via a maternal laparotomy and can therefore not be classified as being truly minimally invasive. DISCUSSION: our results demonstrate that minimally invasive fetoscopic bimanual surgery is rare, even in animal models, excluding many other techniques and procedures that are loosely termed 'minimally invasive fetal surgery' which we suggest to better label as 'interventions'. Thus, more research on percutaneous minimally invasive bimanual fetoscopic surgery is warranted, with the aim to reduce the maternal, uterine and fetal trauma for correction of congenital malformations.

Fetal Surgery for Gastroschisis-A Review with Emphasis on Minimally Invasive Procedures.

(1) Background: The morbidity of gastroschisis is defined by exposure of unprotected intestines to the amniotic fluid leading to inflammatory damage and consecutive intestinal dysmotility, the viscero-abdominal disproportion which results in an abdomen too small to incorporate the herniated and often swollen intestine, and by associated pathologies, such as in complex gastroschisis. To prevent intestinal damage and to provide for growth of the abdominal cavity, fetal interventions such as amnio exchange, gastroschisis repair or covering have been evaluated in several animal models and human trials. This review aims to evaluate the reported techniques for the fetal treatment of gastroschisis by focusing on minimally invasive procedures. (2) Methods: We conducted a systematic database search, quality assessment and analyzed relevant articles which evaluate or describe surgical techniques for the prenatal surgical management of gastroschisis in animal models or human application. (3) Results: Of 96 identified reports, 42 eligible studies were included. Fetal interventions for gastroschisis in humans are only reported for EXIT procedures and amnio exchange. In animal models, particularly in the fetal sheep model, several techniques of open or minimally invasive repair of gastroschisis or covering the intestine have been described, with fetoscopic covering being the most encouraging. (4) Discussion: Although some promising minimally invasive techniques have been demonstrated in human application and animal models, most of them are still associated with relevant fetal morbidity and mortality and barely appear to be currently applicable in humans. Further research on specific procedures, instruments and materials is needed before any human application.

Evaluation of the Versius Robotic Surgical System for Procedures in Small Cavities.

BACKGROUND: The Versius® is a recently approved robotic surgical system for general surgery procedures in adults. Before any application in children, data of its feasibility and safety in small cavities has to be compiled, beginning with inanimate models. Therefore, the aim of this preclinical study was to assess the Versius® system for its performance in small boxes simulating small body cavities. METHODS: In total, 8 cardboard boxes of decreasing volumes (15.75 L to 106 mL) were used. The procedures, two single stitches with two square knots each, were performed in every box, starting in the largest and consecutively exchanging the box to the next smaller one. The evaluation included procedure time, port placement and pivot point setup, arrangement of the robotic arms and instrumentation, amount of internal and external instrument-instrument collisions and instrument-box collisions. RESULTS: All procedures could be successfully performed in all boxes. The procedure time decreased due to the learning curve in the first four boxes (15.75 to 1.87 L) and consecutively increased from boxes of 1.22 L up to the smallest box with the dimensions of 4.4 × 4.9 × 4.9 cm3. This may be based on the progress of complexity of the procedures in small cavities, which is also depicted by the synchronous increase of the internal instrument-instrument and instrument-box collisions. CONCLUSION: With the use of the Versius® robotic surgical system, we were able to perform robotic reconstructive procedures, such as intracorporal suturing and knot tying, in cavities as small as 106 mL. Whether this system is comparable or even superior to conventional laparoscopic surgery in small cavities, such as in children, has to be evaluated. Furthermore, before any application in newborns or infants, ongoing evaluation of this system should be performed in a live animal model.

Robotic infant surgery with 3 mm instruments: a study in piglets of less than 10 kg body weight.

No data exist concerning the appication of a new robotic system with 3 mm instruments (Senhance®, Transenterix) in infants and small children. Therefore, the aim of this study was to test the system for its feasibility, performance and safety of robotic pediatric abdominal and thoracic surgery in piglets simulating infants with a body weight lower than 10 kg. 34 procedures (from explorative laparoscopy to thoracoscopic esophageal repair) were performed in 12 piglets with a median age of 23 (interquartile range: 12-28) days and a median body weight of 6.9 (6.1-7.3) kg. The Senhance® robotic system was used with 3 mm instruments, a 10 mm 3D 0° or 30° videoscope and advanced energy devices, the setup consisted of the master console and three separate arms. The amount, size, and position of the applied ports, their distance as well as the distance between the three operator arms of the robot, external and internal collisions, and complications of the procedures were recorded and analyzed. We were able to perform all planned surgical procedures with 3 mm robotic instruments in piglets with a median body weight of less than 7 kg. We encountered two non-robot associated complications (bleeding from the inferior caval and hepatic vein) which led to termination of the live procedures. Technical limitations were the reaction time and speed of robotic camera movement with eye tracking, the excessive bending of the 3 mm instruments and intermittent need of re-calibration of the fulcrum point. Robotic newborn and infant surgery appears technically feasible with the Senhance® system. Software adjustments for camera movement and sensitivity of the fulcrum point calibration algorithm to adjust for the increased compliance of the abdominal wall of infants, therefore reducing the bending of the instruments, need to be implemented by the manufacturer as a result of our study. To further evaluate the Senhance® system, prospective trials comparing it to open, laparoscopic and other robotic systems are needed.

Stereological Lung Parameters After Fetoscopic Abdominal Decompression of Congenital Diaphragmatic Hernia in an Ovine Model: A Pilot Study.

Background: Fetoscopic endoluminal tracheal occlusion (FETO) improves lung maturation in severe cases of congenital diaphragmatic hernia (CDH) but it does not ameliorate lung compression by herniated abdominal organs. Surgically opening the fetal abdomen (abdominal decompression [AD]) reduces the intrathoracic pressure by diverting the abdominal organs into the amniotic cavity-a probable causal therapy for lung hypoplasia and pulmonary hypertension in CDH. Open surgical abdominal decompression has been reported: we describe a minimally invasive approach in an ovine model of CDH as a probable fetoscopic intervention. Materials and Methods: Eight fetuses were included, 2 were kept as HEALTHY controls. A CDH (left side, liver down) was created by open fetal surgery at midgestation in 6 fetuses, 2 were taken as CDH controls. Fetoscopic abdominal decompression (fAD) was performed 21 days later in 4 animals. The fetuses were retrieved at the end of gestation and evaluated by lung stereology. Results: fAD led to a near total evacuation of the thoracic cavity in 2 of the 4 animals. Fetuses with CDH had a lower total volume and fraction of alveolar air space, a lower volume fraction of the parenchyma, and an increase of the volume fraction of the alveolar septa and atelectasis, as well as an increased mean thickness of alveolar septa compared with HEALTHY fetuses. Fetuses treated with abdominal decompression showed an improvement of stereological parameters. Conclusions: In spite of relevant limitations (pilot study, small groups, spontaneous closure of the abdominal incision) we were able to demonstrate that abdominal decompression for CDH can be performed by fetoscopy. Our results support the hypothesis of causally improving lung development by abdominal decompression, thus implying increased survival in extreme cases of CDH. A refinement of the fetoscopic techniques and direct comparison to FETO appears warranted.

Advances and Trends in Pediatric Minimally Invasive Surgery.

As many meta-analyses comparing pediatric minimally invasive to open surgery can be found in the literature, the aim of this review is to summarize the current state of minimally invasive pediatric surgery and specifically focus on the trends and developments which we expect in the upcoming years. Print and electronic databases were systematically searched for specific keywords, and cross-link searches with references found in the literature were added. Full-text articles were obtained, and eligibility criteria were applied independently. Pediatric minimally invasive surgery is a wide field, ranging from minimally invasive fetal surgery over microlaparoscopy in newborns to robotic surgery in adolescents. New techniques and devices, like natural orifice transluminal endoscopic surgery (NOTES), single-incision and endoscopic surgery, as well as the artificial uterus as a backup for surgery in preterm fetuses, all contribute to the development of less invasive procedures for children. In spite of all promising technical developments which will definitely change the way pediatric surgeons will perform minimally invasive procedures in the upcoming years, one must bear in mind that only hard data of prospective randomized controlled and double-blind trials can validate whether these techniques and devices really improve the surgical outcome of our patients.

Prognostic value of radiobiological hypoxia during fractionated irradiation for local tumor control.

BACKGROUND AND PURPOSE: Previous experiments showed that the fraction of radiobiologically hypoxic tumor cells (rHF) in un-treated tumors did not accurately predict local tumor control after fractionated irradiation. Thus, the prognostic value of rHF determined during fractionated irradiation was investigated. MATERIALS AND METHODS: Six human squamous cell carcinoma lines were transplanted into nude mice and then irradiated with 15 fractions over 3 weeks. Thereafter, single dose irradiation under normal and clamped blood flow was given. Local tumor control rates were used to calculate the rHF and the TCD50, i.e., the radiation dose necessary to control 50% of the tumors, after single dose irradiation. These values were compared with the in parallel determined TCD50 after 30 fractions in 6 weeks. RESULTS: The rHF after 15 fractions varied between 28% and 100%. No correlation was found with the TCD50 after 30 fractions in 6 weeks. Single dose top-up TCD50 under ambient and clamp conditions after 15 fractions significantly correlated with TCD50 after 30 fractions in 6 weeks. CONCLUSION: rHF after 15 fractions is not a prognostic parameter for the outcome after fractionated irradiation. In contrast, the radiobiological parameters number of tumor stem cells, intrinsic radiosensitivity, and number of radiobiologically hypoxic tumor cells appear promising to predict outcome after fractionated irradiation.

Exploratory study of the prognostic value of microenvironmental parameters during fractionated irradiation in human squamous cell carcinoma xenografts.

PURPOSE: To explore the prognostic value of microenvironmental parameters for local tumor control determined before and during fractionated irradiation. METHODS AND MATERIALS: Six human squamous cell carcinoma (hSCC) lines were transplanted subcutaneously into the right hind leg of nude mice. Tumors were irradiated with 30 fractions within 6 weeks. Local tumor control was determined 120 days after irradiation. Radiation response was quantified as dose to cure 50% of tumors (TCD(50)). In parallel, untreated and irradiated tumors were excised after injection of pimonidazole (hypoxia marker) and Hoechst 33342 (perfusion marker) for histological evaluation. RESULTS: Pimonidazole hypoxia decreased during fractionated irradiation in the majority of tumor lines. Fraction of perfused vessels and vascular area showed modest changes during fractionated irradiation. Histological parameters before treatment and after three and five fractions did not significantly correlate with TCD(50) after irradiation with 30 fractions within 6 weeks (p > 0.05). Hypoxic volume and perfused vessels after 10 fractions showed a significant association with local tumor control after fractionated irradiation (p = 0.018 and p = 0.019, respectively). None of these parameters remained statistically significant when the p value was adjusted for multiple comparisons. CONCLUSIONS: The results from this exploratory study suggest that determination of microenvironmental parameters during treatment provides better prognostic information for the outcome after fractionated radiotherapy than pretreatment parameters, which warrants further investigation and confirmation in experimental and clinical studies.