Endoscopic submucosal dissection with adaptive traction strategy: first prospective multicenter study (with video).

BACKGROUND AND AIMS: Traction has become the reference strategy for colorectal endoscopic submucosal dissection (ESD). One of its major limitations is that the force of traction decreases as dissection progresses. The ATRACT traction device (ATRACT Device and Co, Lyon, France) uses a pulley system to increase traction during the procedure, making it easier and faster. A retrospective study of 54 cases showed interesting results in terms of efficacy and safety throughout the digestive tract. We sought to confirm these initial results with a prospective study of resections of colorectal lesions. METHODS: In this prospective multicenter study, 5 experienced operators from 3 different centers each performed 10 procedures using the ATRACT device consecutively for all conventional colorectal ESDs measuring between 4 and 10 cm in conventional locations (no recurrent lesions, appendicular, of the ileocecal valve, in contact with the pectinate line, or measuring more than two-thirds of the circumference). RESULTS: Between November 2022 and April 2023, 50 ESDs were performed in 49 patients. On average, the main diameter of the lesions was 66.6 mm, with a surface area of 3066 mm2. The mean operating time was 55.2 minutes, resulting in a mean resection speed of 61.4 mm2/min. En bloc and R0 resection rates were 100% and 98%, respectively. Resections were curative in 94% of cases. Four (8%) perforations occurred, all of which were closed endoscopically without the need for surgery. One (2%) case of delayed hemorrhage was noted. To date, this is the series with the highest resection speeds in the literature for colorectal ESD. For comparison, previous studies reported a speed of 23.5 mm2/min using the "pocket" strategy and a speed of 39.1 mm2/min using the double-clip traction technique. These results need to be confirmed in larger studies and in nonexpert centers. CONCLUSIONS: This prospective evaluation confirms the efficacy and safety of the adaptive traction strategy with the ATRACT device for colorectal ESD with high resection speed.

Multicenter prospective randomized controlled clinical trial comparing the pocket-creation method with and without single-clip traction of colonic endoscopic submucosal dissection.

BACKGROUND: The pocket-creation method (PCM) was developed to overcome the technical difficulties of endoscopic submucosal dissection (ESD), although opening the pocket remains challenging. We developed a novel technique of PCM with single-clip traction (PCM-CT), which uses a reopenable clip as a traction device to maintain stability during the procedure. No prospective study has compared the efficacy of PCM-CT and PCM. This study aimed to investigate the effectiveness of PCM-CT vs. PCM in a randomized controlled trial. METHODS: This randomized controlled clinical trial was conducted at four Japanese institutions. Patients with superficial colorectal neoplastic lesions were included following Japanese guidelines for colorectal cancer. Seven moderately experienced endoscopists performed the ESD procedures using either PCM-CT or PCM. RESULTS: 100 patients were enrolled in the study. Compared with PCM, PCM-CT achieved significantly faster mean (SD) dissection speed (21.4 [10.8] vs. 27.0 [14.5] mm2/min [95%CI 0.5 to 10.7], P = 0.03), and reduced the mean procedure time (81.8 [57.9] vs. 64.8 [47.6] minutes [95%CI -38.2 to 4.3], P = 0.12) and pocket-opening time (37.8 [33.0] vs. 30.0 [28.9] minutes [95%CI -20.2 to 4.6], P = 0.22). En bloc and R0 resection rates were not significantly different between the two groups (100% vs. 100%, P >0.99; 100% vs. 96%, P = 0.50, respectively). No significant differences were observed in adverse events between the two groups. CONCLUSION: ESD facilitated by the novel PCM-CT method appeared to be significantly faster than PCM. Both methods achieved high R0 resection rates.

Development of a novel multipoint traction device for gastric and colorectal endoscopic submucosal dissection and evaluation of its efficacy and safety.

BACKGROUND: Proper traction allows safer and easier endoscopic submucosal dissection; however, single-point traction may not be sufficient. In this study we assessed the safety, efficacy, and feasibility of our newly developed multipoint traction device. METHODS: During an ex vivo study using a Konjac training model, two experts and two trainees resected 80 mock lesions of 20-mm diameter by performing endoscopic submucosal dissection with and without multipoint traction. The primary outcome was the success rate of the procedure involving traction. The secondary outcomes were the submucosal dissection time, dissection speed, and perforation during endoscopic submucosal dissection. During the in vivo study, to clarify the initial clinical outcomes, we used data from the electronic medical record of patients at our institution who underwent gastric and colorectal endoscopic submucosal dissection, which was performed by experts with our newly developed multipoint traction device, from March to December 2022. RESULTS: The ex vivo study indicated that all traction procedures were successful. Higher resection speeds were observed with endoscopic submucosal dissection with traction than without traction (P < 0.001). Perforations were not observed. During the first in vivo clinical study, traction was feasible during 20 gastric and colorectal endoscopic submucosal dissection procedures. No adverse events occurred. CONCLUSIONS: Our multitraction device can increase the submucosal dissection speed and simplify endoscopic submucosal dissection techniques, thus safely reducing technical challenges. The application of this device for endoscopic submucosal dissection could lead to safer and more efficient procedures. Clinical registration UMIN Clinical Trials Registry, Japan (registration number UMIN000053384).

A Retrospective Study of 290 Patients with Resectable Benign and Malignant Gastric Neoplasms to Compare Postoperative Outcomes of Endoscopic Resection with and without the Internal Traction Method Using a Spring-and-Loop with Clip (S-O Clip).

BACKGROUND The spring-and-loop with clip (S-O clip) consists of a spring and a nylon loop located on one side of the claws of the clip, and is used in gastric endoscopic submucosal dissection (ESD) to allow countertraction. This retrospective study included 290 patients with early gastric neoplasms (eGNs) and aimed to compare postoperative outcomes of ESD with and without the use of the S-O clip. MATERIAL AND METHODS We retrospectively reviewed the data of 347 patients with eGN who underwent ESD, with or without an S-O clip, at our institution between April 1, 2017 and March 31, 2023. Overall, 290 patients were analyzed after excluding ineligible participants. The control group (n=149; adenoma: 1, carcinoma: 148) underwent ESD without an S-O clip between April 2017 and March 2020, while the S-O group (n=141; adenoma: 4, carcinoma: 137) used the clip between April 2020 and March 2023. Primary outcomes included procedure time, en bloc resection rate, and complete resection rate. Subgroup analysis for examined procedure time concerning endoscopist expertise, submucosal fibrosis, and neoplasm locations. RESULTS The S-O group had a shorter procedure time (44.4±23.9 vs 61.1±40.9 min, P<0.001) and a higher complete resection rate (97.9% vs 92.6%, P<0.05) than the control group. Subgroup analysis revealed that the S-O clip significantly reduced procedure time for trainees compared to the control group (40.8±18.3 vs 61.1±35.6 min, P<0.05). CONCLUSIONS The scheduled use of S-O clips in gastric ESD is effective in improving procedural time and complete resection rates, benefiting endoscopists across all experience levels.

Postoperative Intermaxillary Elastic Traction Contributes to the Stability of Absorbable Plates Fixation for Bilateral Mandibular Fracture.

The use of absorbable plates can be challenging for mandibular fractures involving bilateral dentition. Chewing and mouth opening movements may cause loosening or breakage of absorbable materials, leading to displacement of bone segments and resulting in malocclusion. The use of absorbable materials for bilateral mandibular fracture surgery itself raises concerns for surgeons. Timely intermaxillary elastic traction is essential for these patients after surgery to maintain correct occlusion. The surgical approaches were performed with intraoral mandibular sulcus incisions. During the surgery, intermaxillary fixation screws were implanted and steel wires were used for intermaxillary ligation and fixation to restore the occlusal. After the fractured segments were sequentially reduced, they were fixed with inion 2.0 absorbable plates. The patient underwent intermaxillary elastic traction for 1 week. Elastic mask was used to assist in stabilizing the position of the jawbone and maintaining occlusion. After discharge, the patient continued traction at home for 3 weeks before removing the intermaxillary fixation screws. The patient recovered well after surgery without any complications. The postoperative occlusal relationship is good. Postoperative CT showed good reduction of the fractured segments. For the case reported in this article, elastic traction was promptly implemented after surgery. We emphasize that restoring occlusion is always the treatment goal for jawbone fractures. We believe that keeping the intermaxillary fixation screws for a month is a wise choice to be prepared for unexpected needs.

Use of a new vertical traction device for early traction-assisted staged closure of congenital abdominal wall defects: a prospective series of 16 patients.

PURPOSE: Abdominal wall closure in patients with giant omphalocele (GOC) and complicated gastroschisis (GS) remains to be a surgical challenge. To facilitate an early complete abdominal wall closure, we investigated the combination of a staged closure technique with continuous traction to the abdominal wall using a newly designed vertical traction device for newborns. METHODS: Four tertiary pediatric surgery departments participated in the study between 04/2022 and 11/2023. In case primary organ reduction and abdominal wall closure were not amenable, patients underwent a traction-assisted abdominal wall closure applying fasciotens®Pediatric. Outcome parameters were time to closure, surgical complications, infections, and hernia formation. RESULTS: Ten patients with GOC and 6 patients with GS were included. Complete fascial closure was achieved after a median time of 7 days (range 4-22) in GOC and 5 days (range 4-11) in GS. There were two cases of tear-outs of traction sutures and one skin suture line dehiscence after fascial closure. No surgical site infection or signs of abdominal compartment syndrome were seen. No ventral or umbilical hernia occurred after a median follow-up of 12 months (range 4-22). CONCLUSION: Traction-assisted staged closure using fasciotens®Pediatric enabled an early tension-less fascial closure in GOC and GS in the newborn period.

Traumatic vertebral artery dissection associated with cervical neck traction devices.

Cervical arterial dissection (CAD) is a common cause of stroke in young people which can be classified as either spontaneous or traumatic. The primary initial symptoms are headache, neck pain, and dizziness. Recently, a 57-year-old woman experienced a severe headache after using a cervical neck traction device. Radiological examination of the head and neck revealed right vertebral artery dissection, which emphasizes the importance of recognizing that using cervical neck traction devices increases the risk of traumatic vertebral artery dissection.

The Use of Halo Gravity Traction in Severe, Stiff Scoliosis.

PURPOSE: The correction of severe, stiff scoliosis in children is challenging. One method used to reduce the risk is preoperative halo gravity traction (HGT). In this study, the authors sought to define the efficiency and safety of HGT and characterize the chronology of the correction seen. METHOD: A consecutive group of pediatric patients with severe spinal deformities was treated with HGT before definitive correction. A standard protocol with the daily addition of weight to 50% of body weight at 3 weeks was used. Traction remained in place until signs of impending neurological complication or 6 weeks, whichever was sooner. RESULTS: Twenty-four patients were included with a mean age of 11.8 years. The mean coronal deformity was 123 degrees, with a T1-L5 height of 234 mm. The mean duration of traction was 42 days with a mean improvement in height of 72 mm with 82% occurring over the first 3 weeks. Hundred percent of the angular and 98% of T1-L5 height correction was reached by 6 weeks.One patient showed early signs of a cranial nerve palsy prompting early surgery and 8 patients showed pin loosening, 1 of which required revision of their halo. One patient underwent a slower progression of traction because of transitory urinary disturbance. Following fusion, angular correction of the major curve was 49%. CONCLUSION: HGT is a safe treatment for severe, stiff scoliosis because it can respond to early signs of impending neurological impairment. The first 3 weeks of treatment, reaching 50% of body weight as a traction force accounts for 80% of correction, with the remaining 20% in the following 2 weeks. At least 4 weeks of traction is recommended when following this protocol.

Successful endotracheal intubation using i-gel supraglottic airway device and ultrasonography in a patient with bedside cervical traction: A case report.

We report a case of successful endotracheal intubation using i-gel and ultrasonography without a laryngoscope in a patient with a bedside cervical traction device. A 57-year-old man was referred to the emergency department because of quadriparesis following a motor vehicle accident, who was confirmed to have cervical dislocation with spinal cord compression. For ventilation support, the i-gel rescue airway device was placed to secure the patient airway temporarily. Then, an endotracheal tube was passed through the stem of the i-gel while observing the optimal tube position with ultrasonography. This case showed that ultrasonography can be used for early confirmation of endotracheal tube placement into the trachea via the i-gel.

Evaluation of a robotic arm-assisted endoscope to facilitate endoscopic submucosal dissection (with video).

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is considered technically difficult and challenging using a conventional flexible endoscope, mainly due to the lack of proper countertraction to expose the submucosal dissection plane. This study aimed to evaluate the feasibility of a traction method using a dexterous robotic arm in ex vivo gastric ESD. METHODS: ESD was performed in a total of 45 procedures using a portable endoscopic tool handler (PETH) (n = 30) and using the conventional method (n = 15) at various locations in the stomach. For each procedure, the performance data were recorded, including the total procedure time (minutes), incision time (minutes), dissection speed (mm2/minute), and blind dissection rate (%), to enable a comparison of the 2 ESD methods. RESULTS: The total procedure time was significantly shorter with PETH-ESD than in conventional ESD (23 vs 36 minutes, P = .011). This result is mainly attributed to the dissection speed, which was significantly faster, by more than 2.5 times, using the PETH (122.3 ± 76.5 vs 47.5 ± 26.9 mm2/minute, P < .001). The blind dissection rate was greatly decreased in PETH-ESD (0 vs 20%, P < .001). There was no significant difference in the incision time (6.1 ± 5.0 vs 5.5 ± 2.9 min, P = .612). CONCLUSIONS: The countertraction method using the PETH significantly improved the dissection speed and reduced blind dissection by enhancing direct visualization of the submucosal plane. With the advantages of multidirectional traction, fine tension control, and regrasping, this new device is expected to improve the performance of ESD and further facilitate advanced endoscopic procedures.

Multiloop as a novel traction method in accelerating colorectal endoscopic submucosal dissection.

BACKGROUND AND AIMS: Traction methods have been reported to speed up endoscopic submucosal dissection (ESD). We used the multiloop (M-loop) method as a traction method for colorectal ESD and recorded the submucosal dissection time (SDT) and submucosal dissection speed (SDS). METHODS: From January to August 2018, we used the M-loop method for colorectal ESD procedures and timed the duration and recorded the outcomes. Two experts and eight nonexperts performed the procedures, which were carried out at a tertiary endoscopic center in Japan. RESULTS: A total of 50 patients were treated by colorectal ESD using the M-loop method. The mean SDT was 42.1 ± 4.16 minutes and the mean SDS was 28.0 ± 2.89 mm2/minutes. The mean SDS was 38.9 ± 6.9 mm2/minutes for experts and 25.3 ± 3.1 mm2/minutes for nonexperts. En bloc resection was achieved in 100% of cases. There were 3 adverse events and unfavorable outcomes. CONCLUSIONS: Traction by the M-loop method improved SDS in colorectal ESD. The method can be an effective tool to assist colorectal ESD. Further evaluation of the usefulness of the M-loop method is required in direct comparison with conventional ESD.

Internal traction method using a spring-and-loop with clip (S-O clip) allows countertraction in gastric endoscopic submucosal dissection.

BACKGROUND: Insufficient countertraction and poor field of vision make endoscopic submucosal dissection (ESD) difficult. Internal traction method using a spring-and-loop with clip (SLC) allows sufficient traction in any direction and good field of vision. However, the attachment procedure is difficult and interference with the endoscope can occur in the retroflexed endoscopic position. We have developed a new use of SLC that simplifies the attachment procedure, eliminating interference with the endoscope. The aim of this study was to investigate the efficacy of SLC for gastric ESD. METHODS: We retrospectively recruited 140 patients with gastric neoplasms who underwent ESD between November 2015 and October 2018 at our department. Among them, 51 patients treated using SLC-assisted ESD (SLC-ESD) and 89 patients treated using conventional ESD (C-ESD) were compared. Propensity score matching was performed to compensate for the differences in age, sex, lesion location, lesion position, specimen size, and ulcer findings. The primary outcome was ESD procedure time. RESULTS: Propensity score matching generated 51 matched pairs. The procedure time in the SLC-ESD group was significantly shorter than that in the C-ESD group (median [interquartile], 40.0 [27.0-81.5] minutes versus 69.0 [46.5-113.5] minutes, P = 0.008). The mean SLC attachment time was 2.08 min. There were no significant differences in complete en bloc resection rate between SLC-ESD and C-ESD groups (100% versus 96.1%, P = 0.495). There were not perforation cases in either group. CONCLUSIONS: SLC may offer an efficient method for gastric ESD, with a short attachment procedure time.

Intraoperative Issues and Clinical and Radiographic Outcomes of Femur Fractures Treated With Flexible Nails: A Comparison of Cases Utilizing Skeletal Traction and a Traction Table to Cases Using Manual Traction Only.

INTRODUCTION: The use of the orthopaedic traction table (OTT) during elastic stable intramedullary nailing (ESIN) in the management of displaced diaphyseal femur fractures (DFFs) is still debated. In most centers, children with displaced DFF are treated using an OTT. In some other institutions, however, fracture reduction and stabilization by ESIN are performed on a radiolucent table without an OTT. The aim of this study was to evaluate the clinical and radiologic outcome of children with displaced DFF managed by ESIN with and without the use of an OTT. METHODS: Charts and radiographs were retrospectively reviewed for all pediatric patients sustaining DFF managed by ESIN from 2011 to 2017 at 2 different institutions. In all, 69 consecutive children with displaced DFF were recorded, of whom 35 underwent operative treatment by ESIN with the use of an OTT with skeletal traction (Group A), and 34 by ESIN without OTT (Group B). The titanium elastic nails outcome measure scale score and Beaty radiologic criteria were used to evaluate the results. RESULTS: Average patient age at time of injury was 9 years (range, 5 to 13) and 10 years (range, 4 to 15) in Groups A and B, respectively. The mean follow-up was 54 months (range, 24 to 96). Overall, complications were observed in 6 patients (8.6%). Complication rate was higher among children managed without OTT (11.8%) than among children treated with OTT (2.5%); no complication related to pin insertion for skeletal traction was recorded. However, the number of patients with a poor outcome according to the titanium elastic nails outcome score was higher in Group A (20%) than in Group B (5.8%). Beaty radiologic criteria were comparable between the 2 groups. Mean length of surgery and mean cumulative time of radiation exposure during surgery were similar between the 2 groups. CONCLUSIONS: Overall, both techniques work equally well although patients treated by ESIN with the use of an OTT and skeletal traction tended to have a lower rate of complications and radiologic outcome was worse than for patients treated without using an OTT; however, no statistically significant difference was found.Despite their limitations, the results of this study suggest that displaced DFF can be safely managed by ESIN with or without the use of intraoperative OTT and skeletal traction, according to the surgeon's preference. Further studies are now needed to consolidate these conclusions and clarify the role of the OTT. LEVEL OF EVIDENCE: Level III.

Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial.

PURPOSE: Current penile traction therapy devices have significant limitations, including the need to use them for 3 to 8 hours per day. Given these issues, the novel RestoreX® penile traction therapy device was developed in cooperation with Mayo Clinic. MATERIALS AND METHODS: We performed a randomized, controlled, single-blind, intent to treat trial (ClinicalTrials.gov NCT03389854) in men with Peyronie's disease who were assigned to the penile traction therapy device for 30 to 90 minutes per day or to no therapy for 3 months. Study inclusion criteria were curvature 30 degrees or greater with no study exclusions due to complex curvature, hourglass deformity, prior Peyronie's disease therapy or surgery, or calcification. The primary outcome was safety and secondary outcomes were penile length and curvature, and questionnaire responses. RESULTS: A total of 110 men were randomized 3:1 to the penile traction therapy group or the control group. The cohorts were well matched with a mean age of 58.4 years, a 49.7-month Peyronie's disease history and 59.3 degree curvature. Overall penile traction therapy was well tolerated with only transient and mild adverse events reported. At 3 months men undergoing penile traction therapy demonstrated significant improvements over controls in penile length (1.5 vs 0 cm, p <0.001), curvature (-11.7 vs 1.3 degrees, p <0.01) and erectile function (4.3 vs -0.7, p = 0.01) according to the International Index of Erectile Function-Erectile Function among men with erectile dysfunction. Overall 77% of the men on penile traction therapy experienced improved curvature (mean -17.2 degrees in 28.2% of responders) while 94% achieved increased length (1.6 cm in 10.9%). Counter bending and the white line indicator improved efficacy, validating key device innovations. Of men who had previously used other penile traction therapy devices 100% preferred the RestoreX device. CONCLUSIONS: Penile traction therapy with the RestoreX device for 30 to 90 minutes per day was safe, and resulted in significant and clinically meaningful improvements in penile curvature and length in men with Peyronie's disease, and in erectile function in men with erectile dysfunction and Peyronie's disease with no significant adverse events. To our knowledge these data represent the only reported improvements for any device used less than 3 to 8 hours per day.