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1.
Comparative Analysis of Hemostatic Efficacy: Local Application of Lancehead Snake Venom Thrombin versus Hemostatic Forceps in Colon Polypectomy
Chen, D., Kou, J., Zhang, J.
Alternative therapies in health and medicine. 2024
Abstract
BACKGROUND Colon polypectomy often involves managing bleeding, and the choice of hemostatic methods is critical for patient outcomes. This study addresses the hemostatic effects of lancehead snake venom thrombin compared to hemostatic forceps in the context of colon polypectomy. OBJECTIVE To compare and assess the effectiveness and safety of local application of lancehead snake venom thrombin and hemostatic forceps in achieving hemostasis during colon polypectomy. DESIGN A randomized controlled trial was conducted to investigate and compare the hemostatic outcomes of two different approaches in colon polypectomy. SETTING The study was conducted at the Affiliated Hospital of Hebei University Hospital from January 2022 to June 2022. PARTICIPANTS A total of 80 patients with colon polyps who met the inclusion criteria were randomly assigned to either the lancehead snake venom thrombin group or the hemostatic forceps group. INTERVENTIONS In the hemostatic forceps group, hemostatic forceps were employed to seal the wound post-polyp resection. In the lancehead snake venom thrombin group, aluminium potassium sulfate gel, in conjunction with locally sprayed lancehead snake venom thrombin, was applied to the wound. PRIMARY OUTCOME MEASURES The study assessed (1) intraoperative immediate bleeding and hemostasis; (2) intraoperative hemostasis time; (3) postoperative delayed post-polypectomy bleeding (DPPB); and (4) adverse reactions as primary outcome measures. RESULTS No significant differences were observed in the incidence rate of intraoperative immediate bleeding and the success rate of intraoperative hemostasis between the two groups. The lancehead snake venom thrombin group exhibited a shorter intraoperative hemostasis time and a lower incidence rate of adverse reactions compared to the hemostatic forceps group. No significant difference was found in the incidence rate of postoperative DPPB between the two groups. CONCLUSION Local application of lancehead snake venom thrombin proves to be more effective and safer than hemostatic forceps in promptly managing bleeding during colon polypectomy.
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2.
Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial
Mumtaz, M., Thompson, R. B., Moon, M. R., Sultan, I., Reece, T. B., Keeling, W. B., DeLaRosa, J.
JTCVS open. 2023;14:134-144
Abstract
OBJECTIVE A kaolin-based nonresorbable hemostatic gauze, QuikClot Control+, has demonstrated effective hemostasis and safety when used for severe/life-threatening (grade 3/4) internal organ space bleeding. We evaluated the efficacy and safety of this gauze for mild to moderate (grade 1-2) bleeding in cardiac surgery compared with control gauze. METHODS This was a randomized, controlled, single-blinded study of patients who underwent cardiac surgery between June 2020 and September 2021 across 7 sites with 231 subjects randomized 2:1 to QuikClot Control+ or control. The primary efficacy end point was hemostasis rate (ie, subjects achieving grade 0 bleed) through up to 10 minutes of bleeding site application, assessed using a semiquantitative validated bleeding severity scale tool. The secondary efficacy end point was the proportion of subjects achieving hemostasis at 5 and 10 minutes. Adverse events, assessed up to 30 days postsurgery, were compared between arms. RESULTS The predominant procedure was coronary artery bypass grafting, and 69.7% and 29.4% were sternal edge and surgical site (suture line)/other bleeds, respectively. Of the QuikClot Control+ subjects, 121 of 153 (79.1%) achieved hemostasis within 5 minutes, compared with 45 of 78 (58.4%) controls (P < .001). At 10 minutes, 137 of 153 patients (89.8%) achieved hemostasis compared with 52 of 78 controls (68.4%) (P < .001). At 5 and 10 minutes, hemostasis was achieved in 20.7% and 21.4% more QuikClot Control+ subjects, respectively, compared with controls (P < .001). There were no significant differences in safety or adverse events between treatment arms. CONCLUSIONS QuikClot Control+ demonstrated superior performance in achieving hemostasis for mild to moderate cardiac surgery bleeding compared with control gauze. The proportion of subjects achieving hemostasis was more than 20% higher in QuikClot Control+ subjects at both timepoints compared with controls, with no significant difference in safety outcomes.
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3.
Minimizing blood loss in laparoscopic myomectomy with temporary occlusion of the hypogastric artery
Balulescu, L., Nistor, S., Lungeanu, D., Brasoveanu, S., Pirtea, M., Secosan, C., Grigoras, D., Caprariu, R., Pasquini, A., Pirtea, L.
Frontiers in medicine. 2023;10:1216455
Abstract
INTRODUCTION Uterine leiomyomas are common benign pelvic tumors. Currently, laparoscopic myomectomy (LM) is the preferred treatment option for women in the fertile age group with symptomatic myomas. The authors hypothesize that combining LM with a bilateral temporary occlusion of the hypogastric artery (TOHA) using vascular clips minimizes uterine blood flow during surgery and can significantly reduce surgery-associated blood loss. MATERIALS AND METHODS This single-center, prospective randomized study was conducted at the Department of Obstetrics and Gynecology, Municipal Emergency Clinical Hospital Timisoara, Romania. Patients aged between 18 and 49 who preferred laparoscopic myomectomy and wished to preserve fertility were included, provided they had intramural uterine leiomyomas larger than 4 cm in diameter that deformed the uterine cavity. The study analyzed data from 60 laparoscopic myomectomies performed by a single surgeon between January 2018 and December 2020. Patients were randomly assigned to either: "LM + TOHA" group (29 patients), and "LM" group (31 patients). The study's main objective was to evaluate the impact of TOHA on perioperative blood loss, expressed as mean differences in Hb (delta Hb). RESULTS Delta Hb was statistically lower in the "LM + TOHA" group compared to "LM" group, with mean ± standard (min-max): 1.68 ± 0.67 (0.39-3.99) vs. 2.63 ± 1.06 (0.83-4.92) g/dL, respectively (p < 0.001). There was a statistically significant higher need for postoperative iron perfusion in the "LM" group, specifically 0 vs. 12 patients (p < 0.001), and lower postoperative anemia in "LM + TOHA" group (p < 0.001). Necessary artery clipping time was 10.62 ± 2.47 (7-15) minutes, with no significant impact on overall operative time: 110.2 ± 13.65 vs. 106.3 ± 16.48 (p = 0.21). There was no difference in the length of hospitalization or 12-month post-intervention fertility. DISCUSSION Performing bilateral TOHA prior to laparoscopic myomectomy has proven to be a valuable technique in reducing surgery-associated blood loss, while minimizing complications during surgery, with no significant increase in the overall operative time. CLINICAL TRIAL REGISTRATION ISRCTN registry, (www.isrctn.com), identifier ISRCTN66897343.
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4.
The Efficiency of a Uterine Isthmus Tourniquet in Minimizing Blood Loss during a Myomectomy-A Prospective Study
Balulescu, L., Brasoveanu, S., Pirtea, M., Balint, O., Ilian, A., Grigoras, D., Olaru, F., Margan, M. M., Alexandru, A., Pirtea, L.
Medicina (Kaunas, Lithuania). 2023;59(11)
Abstract
Background and Objectives: The objective of this study was to assess the effectiveness of using a peri-cervical tourniquet in reducing blood loss during a laparoscopic myomectomy. Materials and Methods: This prospective study evaluated the impact of performing a concomitant tourniquet placement during a laparoscopic myomectomy (LM). A total of 60 patients were randomly allocated to one of two groups: 30 patients who underwent an LM with a tourniquet placement (the TLM group) and 30 patients who benefited from a standard LM (the SLM group). This study's main objective was to evaluate the impact of tourniquet use on perioperative blood loss, which is quantified as the difference in the pre- and postoperative hemoglobin levels (Delta Hb) and the postoperative blood transfusion rate. Results: The mean Delta Hb was statistically lower in the TLM group compared to the SLM group: 1.38 g/dL vs. 2.41 g/dL (p < 0.001). The rate of postoperative iron perfusion in the TLM group was significantly lower compared to the SLM group (4 vs. 13 patients; p = 0.02). All four patients that required a blood transfusion were from the SLM group. On average, the peri-cervical tourniquet fastening time was 10.62 min (between 7 and 15 min), with no significant impact on the overall operative time: 98.50 min for the TLM group compared to 94.66 min for the SLM group. Conclusions: Fastening a tourniquet during a laparoscopic myomectomy is a valuable technique to effectively control intraoperative bleeding and enhance surgical outcomes.
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5.
Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection (DEFeND): A Randomised External Pilot Trial
Bajwa, M. S., Jackson, R., Dhanda, J., Tudur Smith, C., Shaw, R. J., Schache, A. G.
Cancers. 2023;15(20)
Abstract
OBJECTIVES High-quality randomised controlled trials (RCT) to support the use of Fibrin Sealants (FS) in neck dissection (ND) are lacking. The DEFeND trial assessed critical pilot/feasibility questions and signals from clinical outcomes to inform a future definitive trial. PATIENTS AND METHODS The study design piloted was a blinded surgical RCT. All participants underwent unilateral ND for head and neck cancer. Interventional arm: ND with application of FS. CONTROL ARM ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administrative processes. Clinical outcomes included surgical complications (primary outcome), drainage volume, time to drain removal, length of hospital stay, pain and the Neck Dissection Impairment Index. RESULTS Recruitment completed ahead of time. Fifty-three patients were recruited, and 48 were randomised at a rate of 5.3 patients/month. Blinding of patients, research nurses and outcome assessors was effective. Two protocol deviations occurred. Two patients were lost to follow-up. The mean (SD) Comprehensive Complication Index in the interventional arm was 6.5 (12.8), and it was 9.9 (14.2) in the control arm. The median (IQR) time to drain removal (days) was shorter in the interventional arm (2.67 (2.42, 3.58) vs. 3.40 (2.50, 4.27)). However, this did not translate to a clinically significant reduction in median (IQR) length of hospital stay in days (intervention: 3.48 (2.64, 4.54), control: 3.74 (3.11, 4.62)). CONCLUSION The proposed trial design was effective, and a definitive surgical trial is feasible. Whilst there was a tendency for FS to improve clinical outcomes, the effect size did not reach clinical or statistical significance. (ISRCTN99181100).
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6.
The Impact of Tourniquet Usage on TKA Outcome: A Single-Center Prospective Trial
Dragosloveanu S, Dragosloveanu C, Petre M, Gherghe ME, Cotor DC
Medicina (Kaunas, Lithuania). 2023;59(5)
Abstract
Background and Objectives: Total knee arthroplasties (TKAs) are the most effective surgical treatment for end-stage knee osteoarthritis. The tourniquet is used to reduce intraoperative blood loss, improving surgical field visualization. There is much controversy regarding the effectiveness and safety of using a tourniquet during total knee arthroplasties. The purpose of this prospective study is to determine the effect of tourniquet usage during TKAs on early functional outcomes and pain in our center. Materials and Methods: We conducted a randomized controlled trial of patients following a primary total knee replacement between October 2020 and August 2021. We recorded presurgical data, which included age, sex and knee range of motion. Intraoperatively, we measured the amount of blood aspiration and the surgical room time. After the surgery, we measured the amount of blood aspirated through the drains and the hemoglobin. We measured flexion, extension, Visual Analogue Scale (VAS) scores, and Western Ontario and McMaster Universities Arthritis Index (WOMAC score) scores for the functional evaluation. Results: We included 96 patients in the T group and 94 in the NT group, respectively, who remained until the last follow-up. Regarding blood loss, the NT group demonstrated significantly lower levels: 245 ± 97.8 mL intraoperative and 324.8 ± 151.65 mL postoperative, compared to the T group, where we recorded 276 ± 109.2 mL during the surgical procedures and 353.44 ± 101.55 mL after the surgery, (p < 0.05). We also recorded significantly shorter operative room time for the NT group, (p < 0.05). During the follow-up, we noticed postoperative improvements but without significant differences between the groups. Conclusions: We found a significant decrease in bleeding after no tourniquet usage during total knee replacements and shorter operative times. On the other hand, the knee function demonstrated no significant differences between the groups. Further studies may be required in order to assess complications.
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7.
Polyethylene glycol-coated haemostatic patch for prevention of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy: randomized clinical trial
Serradilla-Martin M, Paterna-Lopez S, Palomares-Cano A, Cantalejo-Diaz M, Abadia-Forcen T, Gutierrez-Diez ML, Artigas-Marco C, Serrablo-Requejo A
BJS open. 2023;7(2)
Abstract
BACKGROUND The potential of haemostatic patches to reduce the rate of postoperative pancreatic fistula remains unclear. The aim of this trial was to evaluate the impact of a polyethylene glycol-coated haemostatic patch on the incidence of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy. METHODS In this randomized, single-centre, clinical trial, patients undergoing pancreatoduodenectomy were randomized 1 : 1 to receive pancreatojejunostomy reinforced with two polyethylene glycol-coated haemostatic patches (patch group) or without any reinforcement (control group). The primary outcome was clinically relevant postoperative pancreatic fistula, defined as grade B/C according to International Study Group of Pancreatic Surgery criteria, within 90 days. Key secondary outcomes were length of hospital stay, total rate of postoperative pancreatic fistula, and overall complication rate. RESULTS From 15 May 2018 to 22 June 2020, 72 patients were randomized, and 64 were included in the analyses (31 in the patch group and 33 in the control group). The risk of clinically relevant postoperative pancreatic fistula was reduced by 90 per cent (OR 0.10, 95 per cent c.i. 0.01 to 0.89, P = 0.039). Moreover, the use of the polyethylene glycol-coated patch retained its protective effect on clinically relevant postoperative pancreatic fistula in a multivariable regression model, significantly reducing the risk of clinically relevant postoperative pancreatic fistula by 93 per cent (OR 0.07, 95 per cent c.i. 0.01 to 0.67, P = 0.021), regardless of patient age, sex, or fistula risk score. The incidence of secondary outcomes did not significantly differ between the groups. One patient died within 90 days in the patch group versus three patients in the control group. CONCLUSIONS A polyethylene glycol-coated haemostatic patch reduced the incidence of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy. REGISTRATION NUMBER NCT03419676 (http://www.clinicaltrials.gov).
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8.
Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial
Martel, G., Lenet, T., Wherrett, C., Carrier, F. M., Monette, L., Workneh, A., Brousseau, K., Ruel, M., Chassé, M., Collin, Y., et al
Trials. 2023;24(1):38
Abstract
INTRODUCTION Blood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection. METHODS This study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment. DISCUSSION The results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs. TRIAL REGISTRATION ClinicalTrials.gov NCT03651154 . Registered on August 29 2018.
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9.
Efficacy of a New Hemostatic Dental Sponge in Controlling Bleeding, Pain, and Dry Socket Following Mandibular Posterior Teeth Extraction-A Split-Mouth Randomized Double-Blind Clinical Trial
Mahmoudi, A., Ghavimi, M. A., Maleki Dizaj, S., Sharifi, S., Sajjadi, S. S., Jamei Khosroshahi, A. R.
Journal of clinical medicine. 2023;12(14)
Abstract
AIMS: This study aimed to clinically evaluate of a novel gelatin-based biodegradable sponge after mandibular posterior teeth extraction to assess its abilities in controlling bleeding, pain, and dry socket compared a commercial sponge. TRIAL DESIGN In this study, 26 patients who needed the extraction of two mandibular molar teeth were selected and, in each patient, after tooth extraction, the prepared gelatin sponge was used in the test group and the commercial sponge was used in the control group in the form of a randomized, double-blind, split-mouth clinical trial. The sterile gauzes were used on top of each sponge to absorb the extra blood (unabsorbed blood of sponges) to assess the blood absorption amount. Also, the amount of bleeding was recorded for 1 and 4 h after extraction for two groups. The amount of pain was measured for 12, 24, and 48 h after tooth extraction by Visual Analogue Scale (VAS). All patients also returned for examination four days after extraction to assess the occurrence of dry socket. RESULTS The results showed that the average weight of absorbed blood by sterile gauze in the control group (6.32 ± 1.06 g) was higher than in test group (3.97 ± 1.1 g), e.g., the bleeding control was better for the test group (p < 0.05). Bleeding was observed to be significantly reduced in the test group within 1 h (p = 0.003), within 1-4 h (p = 0.002), and after 4 h (p = 0.042) post-operatively in comparison to the control group. The average pain decreased significantly over time in both groups and the reduction of the pain was significantly higher for the test group (p < 0.05). Just one dry socket case occurred in the control group. CONCLUSION The prepared sponge is recommended for use in dental surgeries because of its abilities in bleeding, pain, and dry socket control.
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10.
Analysis of Hemostatic Effect and Safety of Local Spray Treatment With Hemocoagulase Bothrops Atrox for Injection After Resection of Colon Polyps
Chen, D., Chen, Y., Wang, M.
Alternative therapies in health and medicine. 2023
Abstract
CONTEXT Postoperative bleeding after resection of colon polyps (CPs) is an extremely common adverse event with endoscopic treatment. Hemocoagulase Bothrops Atrox (HBA) is a newly discovered hemostatic substance that contains thrombin-like and coagulation kinase-like enzymes. However, research is lacking about its use for the treatment of intestinal polyps. OBJECTIVE The study intended to examine the hemostatic efficacy and safety of a local spray treatment with HBA, derived from HBA for injection, after CP resection, to provide a new hemostatic method, support HBA's use, and provide evidence for clinical decision making. DESIGN The research team performed a randomized controlled study. SETTING The study took place at the Affiliated Hospital of Hebei University in Baoding, Hebei, China. PARTICIPANTS Participants were 200 patients with CP who received treatment at the hospital between December 2020 and December 2022. INTERVENTION The research team divided participants into two groups with 100 participants each, an intervention group and a control group, using the random number expression method. For hemostasis, the intervention group received a local spray treatment that used HBA for injection, and the control group received metal-clip closure or electrocoagulation. OUTCOME MEASURES The research team measured: (1) the hemostatic efficacy; (2) clinical outcomes-time to hemostasis, hemostasis rate, rebleeding rate, and incidence of late postoperative bleeding; (3) at baseline and at 24h postintervention, the coagulation function-prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen (FIB); (4) at baseline and at 24h postintervention, PLT parameters-platelet count (PLT), procalcitonin (PCT), and mean platelet volume (MPV); (5) economic effects-total number of participants with hemostasis, hospital days, and total hospital costs; and (6) adverse reactions. RESULTS The total hemostatic efficacy for the intervention group was significantly higher than that of the control group (P = .027), and the time to hemostasis was significantly shorter (P < .001) and the hemostasis rate, rebleeding rate, and incidence of late postoperative bleeding were all significantly lower than those of the control group, at P = .009, P = .009, and P = .048, respectively. In addition, the intervention group's postoperative PT, TT, APTT, FIB, and MPV were all significantly lower than those of the control group (all P < .05), while its PLT and PCT were significantly higher than those of the control group (both P < .05). The intervention group's total number of participants with hemostasis, participants with hemostasis, hospital days, and total cost were significantly lower than those of the control group (all P < .05), while no significant difference existed between the groups in the incidence of adverse effects (P > .05). CONCLUSIONS HBA has an excellent hemostatic effect on intestinal polypectomy, with convenient use and high safety. In the future, popularizing the use of HBA in the treatment of intestinal polypectomy can not only effectively guarantee the postoperative safety of patients but also could reduce their economic burden and improve the quality of clinical medical services.