BACKGROUND: The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5-7 mm blood vessels in thoracic surgery.
METHODS: This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed.
CONCLUSIONS: This clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5-7 mm blood vessels in thoracic surgery.
BACKGROUND: ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www.
RESULTS: gov/study/NCT06002737 .

OBJECTIVE: To evaluate the effectiveness of selective bipolar plasmakinetic technology based on bladder irrigation fluid color on hemostasis in HoLEP surgwery METHODS: A total of 209 patients who underwent HoLEP surgery from October 2021 to July 2023 were included and divided into Hemostasis Management Group and control group. the color of the irrigation fluid was categorized into 5 levels and the bipolar plasmakinetic technology was applied when the color came to level 4 or up. The following was analyzed: postoperative use of balloon compression, blood loss, irrigation time, length of hospital stay, and the number of a second operation.
RESULTS: Only 4 patients in Hemostasis Management Group required postoperative urinary catheter balloon compression, while there are 15 in the control group(p=0.03). The average irrigation time for patients in the HM Group with bipolar plasmakinetic hemostasis was 21.88±13.76 hours, compared to that in patients with catheter balloon compression(p=0.007).
CONCLUSIONS: Based on the bladder irrigation color chart, the selective application of bipolar plasmakinetic hemostasis led to a significant reduction in the number of patients requiring postoperative bladder catheter balloon compression. Secondly, the irrigation time of patients who underwent bipolar plasmakinetic hemostasis also decreased.

暂无摘要。

UNASSIGNED: Haemostasis-related complications associated with Medtronic Tri-stapleTM with preloaded buttress material and the novel, naked AEONTM gastrointestinal staplers have not been extensively studied in bariatric surgery. The study aimed to assess and compare the 30-day haemostasis-related complications between Medtronic Tri-stapleTM and AEONTM GIA staplers.
UNASSIGNED: A retrospective analysis was performed on data from patients who underwent primary or revision sleeve gastrectomy (SG) or the sleeve component of single anastomosis duodeno-ileal bypass with SG (SADI-S) in a private hospital in Australia between November 2021 and December 2022. The surgeries were performed by a single surgeon, using either Medtronic Tri-stapleTM or AEONTM staplers.
UNASSIGNED: The analysis included 250 patients, with the first 125 consecutive patients receiving staple line using the Medtronic Tri-stapleTM GIA stapler and the subsequent 125 patients receiving staple line using the AEONTM GIA stapler. Statistical analysis revealed no significant differences in the distribution of surgical procedures between the Medtronic and AEON groups. In the AEON group, there were statistically higher numbers of diabetics and former tobacco users, while other preoperative characteristics did not significantly differ between the two groups. The AEON group had a significantly longer mean operative time, while the length of hospital stay was significantly shorter. No intraoperative or 30-day complications, deaths, emergency room visits, readmissions, or reoperations were observed in either group.
UNASSIGNED: The novel, naked AEONTM stapler demonstrated non-inferiority to the established Medtronic Tri-StapleTM with preloaded buttress material in achieving hemostasis and maintaining staple-line integrity in bariatric surgery.

Electrosurgical and ultrasonic devices are used in surgical procedures for hemostatic sealing and bisection of vascular tissues. Previous benchtop studies alternatively demonstrated successful infrared laser sealing and cutting of blood vessels, in a sequential, two-step approach. This study describes a smaller, laparoscopic device compatible design, and simultaneous approach to sealing and bisection of vessels, with potential optical feedback. A 1470-nm infrared diode laser sealed and bisected 40 porcine renal arteries, ex vivo. A reciprocating, side-firing, optical fiber, housed in a transparent square quartz optical chamber (2.7 × 2.7 × 25 mm outer dimensions), delivered laser energy over an 11 mm scan length, with a range of incident powers (41-59 W) and treatment times (5-21 s). Vessel diameters ranged from 2.5 to 4.8 mm. Vessel burst pressure measurements were performed on each cut end (n = 80) with success indicated by pressures exceeding 360 mmHg. All vessel ends were successfully sealed and bisected (80/80). The highest incident power, 59 W, yielded short treatment times of 5-6 s. Peak temperatures on the external chamber surface reached 103 oC. Time to cool down to body temperature measured 37 s. Infrared lasers simultaneously seal and bisect blood vessels, with treatment times comparable to, and temperatures and cooling times lower than reported for conventional devices. Future work will focus on integrating the fiber and chamber into a standard 5-mm-outer-diameter laparoscopic device. Customization of fiber scan length to match vessel size may also reduce laser energy deposition, enabling lower peak temperatures, treatment times, and cooling times.

During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an \'anastomosis\', may be necessary. Vascular anastomoses can bleed from the needle holes that result from the creation of the anastomoses. Various surgical options are available for achieving hemostasis, or the stopping of bleeding, including the application of sealants directly onto the bleeding vessels or tissues. Sealants are designed for use in vascular surgery as adjuncts when conventional interventions are ineffective and are applied directly by the surgeon to seal bleeding anastomoses. Despite the availability of several different types of sealants, the evidence for the clinical efficacy of these hemostatic adjuncts has not been definitively established in vascular surgery patients.
To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery.
The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023.
We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients.
We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome.
We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes.
Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.

BACKGROUND: Intractable postpartum hemorrhage (PPH) during cesarean section has been a significant concern for obstetricians. We aimed to explore the effectiveness and safety of a new type of uterine compression suture, the step-wise surgical technique of knapsack-like sutures for treating intractable PPH caused by uterine atony and placenta factors in cesarean section.
METHODS: The step-wise surgical technique of knapsack-like sutures was established on the basis of the artful combination of vertical strap-like sutures and an annular suture-ligation technique. This novel surgical technique was applied to 34 patients diagnosed with PPH during cesarean section due to severe uterine atony and placental factors in our department. The hemostatic effects, clinical outcomes and follow-up visit results were all reviewed and analyzed.
RESULTS: This new uterine compression suture successfully stopped bleeding in 33 patients, and the effective rate was 97.06%. Only 1 patient failed and was changed to use bilateral uterine arterial embolization and internal iliac artery embolization. The follow-up visits indicated that 33 patients restored menstruation except for 1 who was diagnosed with amenorrhea. The gynecological ultrasound tests of all the patients suggested good uterine involutions, and they had no obvious complaints such as hypogastralgia.
CONCLUSIONS: This step-wise surgical technique of knapsack-like uterine compression sutures can compress the uterus completely. It is a technique that can conserve the uterus and fertility function without special equipment in caesarean section for PPH, with the characteristics of being safe, simple and stable (3 S) with rapid surgery, reliable hemostasis and resident doctor to operation (3R).

BACKGROUND: Advanced vessel sealing electrosurgical systems have been widely adopted for grasping, cutting, and sealing vessels. Data remain sparse with regard to its use in thoracic procedures. Thus, a prospective case series, utilizing the ENSEAL X1 Curved Jaw Tissue Sealer (X1CJ) and its companion energy source, the Generator 11 (GEN11), in thoracic procedures was performed in a Japanese cohort.
METHODS: Subjects were recruited at two Japanese surgical sites. The primary endpoint of this post-market study was the achievement of hemostasis (≤ Grade 3) for each thoracic vessel transection. Performance endpoints included scores for tasks completed with X1CJ (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection); hemostasis grading vessel transected; additional products required to achieve hemostasis for Grade 4 vessel transections. Safety was evaluated by evaluating device-related adverse events. All endpoint data were summarized.
RESULTS: Forty subjects (50.0% female) of Asian ethnicity with a mean age of 67.6 ± 11.3 years underwent a lung resection. Estimated mean blood loss was 39.5 mL. Hemostasis was achieved in 97.5% of vessel transections. Thirty-seven vessel sealings resulted in a hemostatic Grade 1 (92.5%). All surgeons reported satisfaction/neutral in terms of tissue grasping (100.0%) while most reported satisfaction/neutral with tissue cutting (95.7%). One device-related serious adverse event was reported (2.5%), a chylothorax requiring an extension of hospitalization. There was no post-operative bleeding or deaths reported during the study period.
CONCLUSIONS: The X1CJ demonstrated safe and effective performance without any reports of significant intra-operative or post-operative hemorrhage in thoracic vessel sealing.

OBJECTIVE: Matsudaito is a unique surgical sealant with a powerful hemostatic effect that works independent of a patient\'s blood coagulation function. Because of its mechanism, this sealant is expected to be particularly useful in patients with a poor blood coagulation function, such as in cases of acute aortic syndrome requiring emergency surgery. We, therefore, evaluated the hemostatic static effect of the sealant in both emergency and elective surgery of the thoracic aorta.
METHODS: We used data obtained from post-marketing surveillance of the sealant. Patients who underwent replacement of the thoracic aorta were enrolled. The hemostatic effect was evaluated as effective if a further hemostatic procedure was not performed after applying the sealant.
RESULTS: From 46 hospitals in Japan, a total of 542 patients (327 elective and 215 emergency cases) were enrolled. Hospital mortality was 4.0% and 11.6% in elective and emergency cases, respectively (p < 0.05). Among the 1039 anastomoses (609 elective and 430 emergency cases), effective hemostasis was confirmed in 436 (71.6%) elective and 259 (60.2%) emergency cases. The data from the clinical trial of the sealant showed a hemostatic rate of 44.4% in elective control cases without the sealant.
CONCLUSIONS: Given that the hemostatic rate in emergency surgery with the sealant seemed to be better than that in elective surgery without the sealant (determined from the clinical trial), we concluded that the sealant was effective in both emergency and elective thoracic surgery of the aorta.

OBJECTIVE: In current literature, no studies evaluated effect of energy-based vessel-sealing-devices on quality of life after sutureless total thyroidectomies. This study aimed to identify any potential differences between two energy-based vessel-sealing-devices (Harmonic Focus, Ligasure LF1212) in patients with benign thyroid disorders who underwent sutureless total thyroidectomy.
METHODS: Differences in quality of life of patients were evaluated using data obtained by Thy-PRO-39-Tr questionnaire prior to and four-week after surgery. Total and domain-based alterations in quality of life were compared between groups according to energy-based vessel-sealing-devices type (Group L, Group H). Additionally, data including demographics, height, weight, body mass index, neck circumference, sternomental distance were collected.
RESULTS: Of 1032 patients, 200 were eligible for study, at the end 193 were analysed. There were no differences between groups in terms of age, sex, body mass index, tobacco use. Analysis did not reveal any differences in overall quality of life between groups (P = .42). However, in \"eye symptoms\" (P < .001) and \"cognitive functions\" (P = .002) domains, Harmonic provided statistically improved quality of life. Effect on cognitive function was greater in patients of advanced age.
CONCLUSIONS: Especially in elderly patients with worsening eye conditions and cognitive functions, use of Harmonic may enhance patients\' outcome by increasing quality of life in addition to optimizing surgical outcome when compared to Ligasure.