Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5-7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial.

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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www. CLINICALTRIALS: gov/study/NCT06002737 .

Comparative Analysis of Hemostasis and Staple-Line Integrity between Medtronic Tri-StapleTM with Preloaded Buttress Material and the AEONTM Stapler in Bariatric Surgery.

Background and Objectives: 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. Methods: 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. Results: 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. Conclusion: 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.

Simultaneous sealing and bisection of porcine renal blood vessels, ex vivo, using a continuous-wave, infrared diode laser at 1470 nm.

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.

Clinical Safety and Performance of GATT-Patch for Hemostasis in Minimal to Moderate Bleeding During Open Liver Surgery.

INTRODUCTION: Intraoperative blood loss and postoperative hemorrhage affect outcomes after liver resection. GATT-Patch is a new flexible, pliable hemostatic sealant patch comprising fibrous gelatin carrier impregnated with N-hydroxy-succinimide polyoxazoline. We evaluated safety and performance of the GATT-Patch for hemostasis at the liver resection plane. METHODS: Adult patients undergoing elective open liver surgery were recruited in three centers. GATT-Patch was used for minimal to moderate bleeding at the liver resection plane. The primary endpoint was hemostasis of the first-treated bleeding site at 3 min versus a prespecified performance goal of 65.4%. RESULTS: Two trial stages were performed: I (n = 8) for initial safety and II (n = 39) as the primary outcome cohort. GATT-Patch was applied in 47 patients on 63 bleeding sites. Median age was 60.0 (range 25-80) years and 70% were male. Most (66%) surgeries were for colorectal cancer metastases. The primary endpoint was met in 38 out of 39 patients (97.4%; 95% confidence interval: 84.6%-99.9%) versus 65.4% (P < 0.001). Of all the 63 bleeding sites, hemostasis was 82.7% at 30, 93.7% at 60, and 96.8% at 180 s. No reoperations for rebleeding or device-related issues occurred. CONCLUSIONS: When compared to a performance goal derived from state-of-the-art hemostatic agents, GATT-Patch for the treatment of minimal to moderate bleeding during liver surgery successfully and quickly achieved hemostasis with acceptable safety outcomes. (ClinicalTrials.gov Identifier: NCT04819945).

Novel Image-Guided Percutaneous Lung Tissue Excision Device With Integrated Sealing of Blood Vessels and Airways: An In Vivo Preclinical Study.

OBJECTIVE: This study evaluated the efficacy of the Minimally Invasive Targeted Resection (MiTR) device, a novel electrosurgical instrument that allows for targeted excision of a lung abnormality while using bipolar radiofrequency (RF) energy to seal blood vessels and airways. METHODS: The MiTR system was evaluated in 7 acute and 2 chronic porcine (7-day) models to evaluate the efficacy of tissue excision with bipolar RF sealing of blood vessels and airways and application of an autologous blood patch into the excised tissue cavity. Air leak was recorded for all evaluations. The study was approved by the institutional ethical board. RESULTS: Nineteen lung tissue samples, measuring 2.5 cm long × 1.2 cm diameter, were excised. In 8 of 9 animals (89%), hemostasis and pneumostasis were observed visually at the completion of the procedure. In 2 of 2 chronic animals (100%), hemostasis and pneumostasis persisted for the 7-day observation period. Histologic examination of the excised samples showed preservation of the core parenchymal architecture without evident tissue damage of the samples that would impair pathologic analysis. CONCLUSIONS: Percutaneous resection of targeted lung tissue with the MiTR system demonstrated hemostasis and pneumostasis while obtaining a histologically intact sample. After regulatory approval, the use of this device could offer more tissue for analysis than a transthoracic needle biopsy or bronchoscopy and a far less invasive alternative to video-assisted thoracic surgery or thoracotomy. This may also expand patient and physician options for the early diagnosis and treatment of lung cancer.

Usefulness of endoscopic endonasal underwater surgery using a combination of coblation and a lens-cleaning system for hemostasis in hereditary hemorrhagic telangiectasia.

Hemostatic procedures for controlling nasal bleeding in refractory diseases such as hereditary hemorrhagic telangiectasia (HHT) can be challenging. In this report, we present a novel technique for underwater endoscopic endonasal hemostatic surgery, which was performed on a 69-year-old man with HHT. The patient had been experiencing frequent episodes of nasal bleeding and had many telangiectasias in the nasal cavity, which were the cause of the bleeding. These telangiectasias were effectively treated using a coblation device in combination with an endoscope lens-cleaning system that supplied saline to create stable underwater conditions. There are several advantages to this technique, including provision of a stable and clear endoscopic field of view, allowing for better visualization of the surgical site. This makes it easier to identify bleeding points and ensure accurate hemostasis. Additionally, the hydrostatic pressure created by the underwater environment helps to reduce bleeding during the procedure. However, it is important to take careful precautions to prevent water from entering the lower airway. With this precautionary measure, this technique is particularly useful in managing bleeding in patients with HHT.

Reloadable Stapler Use during Peripartum Hysterectomy for Placenta Accreta Spectrum: A Novel Surgical Technique and Case Series.

OBJECTIVE: This study aimed to describe a novel surgical technique for the management of antenatally suspected placenta accreta spectrum (PAS). STUDY DESIGN: This is a retrospective, case series of patients with suspected PAS undergoing peripartum hysterectomy with a reloadable articulating stapler at a tertiary care center. RESULTS: Eighteen patients with antenatally suspected PAS were identified and underwent peripartum hysterectomy with the aid of a reloadable stapler. Mean gestational age at delivery was 344/7 ± 11/7 weeks. Mean total operative time (skin-to-skin) was 117.3 ± 39.3 minutes, and 79.8 ± 19.8 minutes for the hysterectomy. Mean blood loss for the entire case was 1,809 ± 868 mL. Mean blood loss for the hysterectomy was 431 ± 421 mL. Mean units of intraoperative red blood cells transfused was 3 ± 1 units. Mean units of postoperative red blood cells transfused was 1 ± 0.5 units. Five cases were complicated by urological injury (two intentional cystotomies). Four patients were admitted to the intensive care unit (ICU) for a mean of ≤24 hours. Mean postoperative LOS was 4.11 ± 1.45 days. Three patients had final pathology that did not demonstrate PAS while four were consistent with accreta, six increta, and five percreta. CONCLUSION: Use of a reloadable articulating stapler device as part of the surgical management of antenatally suspected PAS results in a shorter operative time (117 ± 39 minutes vs. 140-254 minutes previously reported), lower average blood loss (1,809 ± 868 mL vs. 2,500-5,000 mL previously reported) and shorter LOS (4.11 ± 1.45 days vs. 9.8 ± 13.5 days previously reported) compared with traditional cesarean hysterectomy. The reloadable stapling device offers an advantage of more rapidly achieving hemostasis in the surgical management of PAS. KEY POINTS: · PAS is associated with severe maternal morbidity.. · Decreased operative time and blood loss have many clinical benefits.. · Reloadable stapler use for PAS decreases operative time.. · Reloadable stapler use for PAS decreases operative blood loss..

Topical Coagulant Agents.

Topical hemostatic agents have continued to develop as knowledge of coagulation physiology and pathophysiology has evolved. The addition of knowledge of hemostatic agents to a surgeon's armamentarium helps to push the boundaries of life-saving care. As the understanding of the complex physiology of coagulation and hemorrhage improves, so will the potential for developing hemostatic agents that are safe, affordable, and readily available. This article discusses topical coagulant agents and hemostatic materials currently available in the surgery. The relevant agents/materials, their characteristics, different utility in surgical hemostasis, and their relevant benefits and drawbacks are reviewed.

Extra Peritoneal Packing for Exsanguinating Pelvic Hemorrhage: Should We Do It in the Emergency Department?

BACKGROUND: Extra peritoneal packing (EPP) is a quick and highly effective method to control pelvic hemorrhage. OBJECTIVES: To determine whether EPP can be as safely and efficiently performed in the emergency department (ED) as in the operating room (OR). METHODS: Retrospective study of 29 patients who underwent EPP in the ED or OR in two trauma centers in Israel 2008-2018. RESULTS: Our study included 29 patients, 13 in the ED-EPP group and 16 in the OR-EPP group. The mean injury severity score (ISS) was 34.9 ± 11.8. Following EPP, hemodynamic stability was successfully achieved in 25 of 29 patients (86.2%). A raise in the mean arterial pressure (MAP) with a median of 25 mmHg (mean 30.0 ± 27.5, P < 0.001) was documented. All patients who did not achieve hemodynamic stability after EPP had multiple sources of bleeding or fatal head injury and eventually succumbed. Patients who underwent EPP in the ED showed higher change in MAP (P = 0.0458). The overall mortality rate was 27.5% (8/29) with no difference between the OR and ED-EPP. No differences were found between ED and OR-EPP in the amount of transfused blood products, surgical site infections, and length of stay in the hospital. However, patients who underwent ED-EPP were more prone to develop deep vein thrombosis (DVT): 50% (5/10) vs. 9% (1/11) in ED and OR-EPP groups respectively (P = 0.038). CONCLUSIONS: EPP is equally effective when performed in the ED or OR with similar surgical site infection rates but higher incidence of DVT.

The accuracy of dry surgical field sublabial biopsy in the diagnosis of sicca syndrome.

BACKGROUND: Sublabial gland biopsy is the 'gold standard' in establishing the diagnosis of primary Sjögren's syndrome. Bleeding and nerve damage are complications. Our centre has adopted the use of the chalazion clamp to provide a dry surgical field to address these challenges. This study aimed to assess the accuracy of minor salivary gland harvest rate using this technique. METHOD: A retrospective review of all minor salivary gland biopsies was carried out in a single tertiary referral centre over a five-year period. RESULTS: Forty-one biopsy patients were identified, with a mean age of 56.1 years. There was 100 per cent accuracy in harvest rate in our series. Twelve patients (29 per cent) were positive for primary Sjögren's syndrome. No patients had a complication immediately or at one month follow up. CONCLUSION: Dry surgical field sublabial gland biopsy is a safe and highly effective technique in the diagnosis of primary Sjögren's syndrome. Initial results indicate it may provide a higher harvest rate with fewer complications than traditional non-ischaemic techniques.

Haemostatic devices in parotid surgery: a systematic review.

OBJECTIVE: The Harmonic Scalpel and Ligasure (Covidien) devices are commonly used in head and neck surgery. Parotidectomy is a complex and intricate surgery that requires careful dissection of the facial nerve. This study aimed to compare surgical outcomes in parotidectomy using these haemostatic devices with traditional scalpel and cautery. METHOD: A systematic review of the literature was performed with subsequent meta-analysis of seven studies that compared the use of haemostatic devices to traditional scalpel and cautery in parotidectomy. Outcome measures included: temporary facial paresis, operating time, intra-operative blood loss, post-operative drain output and length of hospital stay. RESULTS: A total of 7 studies representing 675 patients were identified: 372 patients were treated with haemostatic devices, and 303 patients were treated with scalpel and cautery. Statistically significant outcomes favouring the use of haemostatic devices included operating time, intra-operative blood loss and post-operative drain output. Outcome measures that did not favour either treatment included facial nerve paresis and length of hospital stay. CONCLUSION: Overall, haemostatic devices were found to reduce operating time, intra-operative blood loss and post-operative drain output.

How we do it: 'tonsil swabs please' - an alternative use in open neck surgery.

BACKGROUND: Thyroid and parathyroid surgery often involves the use of heated instruments for dissection. Whilst these are beneficial, accidental thermal damage to the exposed skin edges can occur, resulting in an unsatisfactory cosmetic outcome. Tonsil swabs can be used in head and neck surgery intra-operatively to control bleeding. This paper describes an alternative use for them in protecting wound edges during the procedure. METHOD: Damp tonsil swabs are sutured onto the wound edges after the initial skin incision. They remain present for the duration of the surgery and are removed at the time of skin closure. RESULTS: The tonsil swabs provide protection and help avoid accidental injury to the skin. No complications with this technique have been experienced. CONCLUSION: This paper describes a simple, effective and practical technique for protecting the skin during neck procedures using resources readily available in a standard ENT operating theatre.

Use of 8Fr angio-seal for closure of femoral arteriotomy following use of 8Fr and 9Fr sheaths in patients undergoing mechanical thrombectomy for acute ischaemic stroke.

BACKGROUND: Little is known about the safety of off-label use of an 8Fr Angio-Seal VIP for large-bore arteriotomies in patients treated with mechanical thrombectomy (MT) and intravenous thrombolysis (IVT) for acute ischaemic stroke (AIS). We aimed to identify differences in the groin complication rate using an 8Fr Angio-Seal VIP for common femoral arteriotomy closures following the use of 8Fr and 9Fr sheaths. METHODS: All AIS patients who underwent MT at our tertiary neuroscience unit between January 2018 and March 2020 were retrospectively reviewed. RESULTS: 161 patients were included in the study, of whom 56 and 105 patients underwent an arteriotomy using an 8Fr sheath (36 of them receiving IVT) and a 9Fr sheath (57 of them receiving IVT). Overall, 17 groin complications were identified (10.5%) in 5 patients (8.9%) who had had 8Fr sheaths inserted and 12 patients (11.4%) who had had 9Fr sheaths inserted. Major complications were identified in only 2 patients (1.2%), one patient in each of the 8Fr and 9Fr cohorts suffering a pseudoaneurysm requiring intervention. No retroperitoneal haematoma, infection, acute limb ischaemia or ipsilateral DVT was identified. No significant difference in groin complications was observed between the 8Fr and 9Fr femoral arteriotomy cohorts or between the MT patients that did or did not receive adjunctive IVT. CONCLUSION: In the setting of MT with IVT, off-label use of an 8Fr Angio-Seal VIP for closure of a femoral arteriotomy following use of a 9Fr sheath has a similar safety profile to the licensed use of an 8Fr Angio-Seal VIP for closure of a femoral arteriotomy following use of an 8Fr sheath or smaller.

Literature review of primary versus patching versus eversion as carotid endarterectomy closure.

BACKGROUND: Which type of closure after carotid endarterectomy (CEA), whether primary, patching, or eversion, will provide the optimal results has remained controversial. In the present study, we compared the results of randomized controlled trials (RCTs) and systematic meta-analyses of the various types of closure. METHODS: We conducted a PubMed literature review search to find studies that had compared CEA with primary closure, CEA with patching, and/or eversion CEA (ECEA) during the previous three decades with an emphasis on RCTs, previously reported systematic meta-analyses, large multicenter observational studies (Vascular Quality Initiative data), and recent single-center large studies. RESULTS: The results from RCTs comparing primary patching vs primary closure were as follows. Most of the randomized trials showed CEA with patching was superior to CEA with primary closure in lowering the perioperative stroke rates, stroke and death rates, carotid thrombosis rates, and late restenosis rates. These studies also showed no significant differences between the preferential use of several patch materials, including synthetic patches (polyethylene terephthalate [Dacron; DuPont, Wilmington, Del], Acuseal [Gore Medical, Flagstaff, Ariz], polytetrafluoroethylene, or pericardial patches) and vein patches (saphenous or jugular). The results from observational studies comparing patching vs primary closure were as follows. The Vascular Study Group of New England data showed that the use of patching increased from 71% to 91% (P < .001). Also, the 1-year restenosis and occlusion (P < .01) and 1-year stroke and transient ischemic attack (P < .03) rates were significantly lower statistically with patch closure. The results from the RCTs comparing ECEA vs conventional CEA (CCEA) were as follows. Several RCTs that had compared ECEA with CCEA showed equivalency of CCEA vs ECEA (level 1 evidence) with patching in the perioperative carotid thrombosis and stroke rates. At 4 years after treatment, the incidence of carotid stenosis was lower for ECEA than for primary closure (3.6% vs 9.2%; P = .01) but was comparable between patching and eversion (1.5% for patching vs 2.8% for eversion). CONCLUSIONS: Routine carotid patching or ECEA was superior to primary closure (level 1 evidence). We found no significant differences between the preferential use of several patch materials. The rates of significant post-CEA stenosis for CEA with patching was similar to that with ECEA, and both were superior to primary closure.

Comparison of Surgical Complications Rates Between LigaSure Small Jaw and Clamp-and-Tie Hemostatic Technique in 1,000 Neuro-Monitored Thyroidectomies.

Over the past decade, the use of neuromonitoring in thyroid surgery has become well established and is increasing accepted across the world. In addition, new developments in energy devices have significantly improved efficacy in achieving hemostasis in thyroid surgery. Few studies focused on the complication rates in energy device-assisted sutureless neuro-monitored thyroidectomy. This study investigates a novel LigaSure Small Jaw (LSJ) technique for sutureless thyroidectomy and compares the surgical complication rates between LSJ and conventional clamp-and-tie technique in one thousand consecutive neuro-monitored thyroidectomy patients. Five hundred patients received sutureless thyroidectomy performed with LSJ (Group L), and 500 patients received surgery performed with conventional clamp-and-tie technique (Group C). Complication rates of postoperative hematoma, hypocalcemia and recurrent laryngeal nerve (RLN) palsy were compared between groups. The overall complication rates of hematoma, hypocalcemia (temporary/ permanent), and RLN (temporary/ permanent) palsy were 0.9%, 24.9% (24.6%/0.3%), and 1.7% (1.5%/0.2%), respectively. Group L and Group C significantly differed in postoperative hematoma rate (0.0% vs. 1.8%, respectively; p = 0.0026) and in postoperative hypocalcemia rate (20.1% vs. 30.0%, respectively; p = 0.0032). The incidence of RLN palsy did not significantly differ between Group L and Group C (1.38% vs. 2.08%; p = 0.2652). The overall surgical complication rates are low in neuro-monitored thyroidectomy. The LSJ is feasible for performing completely sutureless thyroidectomy and obtains superior outcomes of postoperative hematoma and hypocalcemia in comparison with clamp-and-tie hemostatic technique. The novel LSJ technique using double or overlapped sealing is useful for sutureless thyroidectomy. However, surgeons must carefully observe the tissue contraction that may reduce the LSJ-RLN distance and increase the risk of thermal injury during the LSJ activation.

LigaSure small jaw versus conventional neck dissection: a systematic review and meta-analysis.

BACKGROUND: Neck dissection has a central role in the management of head and neck cancers. This systematic review aimed to compare the intraoperative and postoperative parameters between conventional and LigaSure Small Jaw (LSJ)-assisted neck dissection. METHODS: PubMed (MEDLINE), Embase, and the Cochrane Library were searched. independently by two authors for relevant articles comparing the outcomes of conventional and LSJ-assisted neck dissection. Data from each study were extracted, and a random-effects model was used in the pooled analysis. RESULTS: Compared with conventional techniques, LSJ-assisted neck dissection was associated with a significantly reduced operative time. The rates of postoperative hematoma, infection, amount of intraoperative blood loss, the length of hospital stay and the drainage amount showed no significant intergroup differences. CONCLUSIONS: The meta-analysis provides evidence that properly using LSJ may reduce the operative time compared with that of conventional techniques. Surgeons may consider using LSJ in neck dissection according to personal experiences.

Time to reconsider the routine use of tourniquets in total knee arthroplasty surgery.

AIMS: Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery. METHODS: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, and trial registries up to 26 March 2020. We included randomized controlled trials (RCTs), comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: pain, function, serious adverse events (SAEs), blood loss, implant stability, duration of surgery, and length of hospital stay. RESULTS: We included 41 RCTs with 2,819 participants. SAEs were significantly more common in the tourniquet group (53/901 vs 26/898, tourniquet vs no tourniquet respectively) (risk ratio 1.73 (95% confidence interval (CI) 1.10 to 2.73). The mean pain score on the first postoperative day was 1.25 points higher (95% CI 0.32 to 2.19) in the tourniquet group. Overall blood loss did not differ between groups (mean difference 8.61 ml; 95% CI -83.76 to 100.97). The mean length of hospital stay was 0.34 days longer in the group that had surgery with a tourniquet (95% CI 0.03 to 0.64) and the mean duration of surgery was 3.7 minutes shorter (95% CI -5.53 to -1.87). CONCLUSION: TKA with a tourniquet is associated with an increased risk of SAEs, pain, and a marginally longer hospital stay. The only finding in favour of tourniquet use was a shorter time in theatre. The results make it difficult to justify the routine use of a tourniquet in TKA surgery. Cite this article: Bone Joint J 2021;103-B(5):830-839.