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Propose: This pilot study aimed to apply the central tenets of bloodless surgery and to analyze the effectiveness of specific preoperative, intraoperative, and postoperative strategies to minimize the risk for blood transfusion after gynecological surgery in a specific group of patients who refused blood products. Methods: A total of 83 patients undergoing gynecological surgery were included in the study. Forty-two patients received preoperatively oral iron, acid folic, and vitamin B12 supplementation in the 30 days before surgery, and 41 patients did not receive therapy. Results: No significant differences were found when comparing the two study groups. The implementation of all procedures to maintain a bloodless surgery has been helpful, in association with the other available procedures, in achieving optimal management and maintenance of hemoglobin levels, even in the most critical situations. Conclusion: In conclusion, implementing the bloodless approach as much as possible could guarantee the patient better and safer clinical and care management. Furthermore, well-designed research is required to clarify further the effects of bloodless surgery in gynecological patients

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Open camera or QR reader andscan code to access this articleand other resources online.ORIGINAL ARTICLE Open AccessBloodless Gynecological Surgeryin Blood Products Refusing Patients:Experience of a Single InstitutionDonatella Caserta,1 Flavia Costanzi,1,* Maria Paola De Marco,1 Aris Raad Besharat,1 Christian Napoli,2Maria Rosaria Aromatario,3 and Stefano Palomba1AbstractPropose: This pilot study aimed to apply the central tenets of bloodless surgery and to analyze the effectivenessof specific preoperative, intraoperative, and postoperative strategies to minimize the risk for blood transfusionafter gynecological surgery in a specific group of patients who refused blood products.Methods: A total of 83 patients undergoing gynecological surgery were included in the study. Forty-two pa-tients received preoperatively oral iron, acid folic, and vitamin B12 supplementation in the 30 days before surgery,and 41 patients did not receive therapy.Results: No significant differences were found when comparing the two study groups. The implementation of allprocedures to maintain a bloodless surgery has been helpful, in association with the other available procedures,in achieving optimal management and maintenance of hemoglobin levels, even in the most critical situations.Conclusion: In conclusion, implementing the bloodless approach as much as possible could guarantee the pa-tient better and safer clinical and care management. Furthermore, well-designed research is required to clarifyfurther the effects of bloodless surgery in gynecological patients.Keywords: bloodless surgery; gynecological; Jehovah’s Witness; iron; acid folic; vitamin B12IntroductionThe Italian National Blood Center promoted, in linewith the Resolution of the World Health Assembly,1an initiative aimed at systematizing innovative andmore effective methods and tools to ensure the appro-priateness of organizational and clinical managementof blood resources. This initiative is identified in an in-novative multiprofessional, multidisciplinary, and multi-modal project that summarizes in the Anglo-Saxondefinition of patient blood management (PBM).2,3 This1Gynecology Division, Department of Medical Surgical Sciences and Translational Medicine, Sant’Andrea University Hospital, Sapienza University of Rome, Rome, Italy.2Department of Medical Surgical Sciences and Translational Medicine, Sant’Andrea University Hospital, Sapienza University of Rome, Rome, Italy.3Department of Anatomical, Histological, Forensic Medicine and Orthopedic Science, Sant’Andrea University Hospital, Sapienza University of Rome, Rome, Italy.*Address correspondence to: Flavia Costanzi, MD, PhD fellow, Gynecology Division, Department of Medical and Surgical Sciences and Translational Medicine, Sant’AndreaUniversity Hospital, Sapienza University of Rome, Via di Grottarossa 1035, Rome 00189, Italy.ª Donatella Caserta et al., 2024; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative CommonsLicense [CC-BY] (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, providedthe original work is properly cited.Women’s Health ReportsVolume 5.1, 2024DOI: 10.1089/whr.2023.0156Accepted February 8, 2024346strategy was already envisaged in the regional and na-tional self-sufficiency program of the blood and its prod-ucts of 2012.4 This program was aimed to give thedefinition and the implementation of ‘‘innovative andmore effective methods and tools to ensure the appro-priateness of the blood resource management, organiza-tional and clinical.’’In November 2015, the Italian minister of health de-fined and implemented specific programs throughoutthe country, with particular reference to the prepara-tion of the patient for scheduled surgical interventions.The PBM approach is based on the implementation ofthe three fundamental pillars: the optimization oferythropoiesis, the containment of blood loss, and theoptimization of tolerance to anemia in the three essen-tial phases of preoperative, operative, and postoperativepatient management.5–8 A programmatic approach toPBM was associated with improved clinical outcomes,optimization of economic resources, and reducedtransfusions.9In the clinical practice, several concerns may beraised to refuse a transfusion of whole blood or otherblood components, such as plasma, erythrocyte con-centrates, leukocytes, and platelets. Those concerns in-clude religious reasons (i.e., Jehovah’s Witnesses),possible blood transfusion-related complications, animmunological incompatibility (rare groups and pres-ence of alloimmunization), or unjustified fear. Thisproblem cannot be overlooked in consideration of theneed of specific and extensive informed consent fortransfusion and its related medicolegal issues.10Considering the specific group of Jehovah’s Wit-nesses patients, it is also necessary to consider the piv-otal role of the specific consensus that plays afundamental role.11 Inviolability remains the moregeneral principle of undoubted constitutional impor-tance, by which the patient must be recognized as hav-ing the choice to be not treated even if such conductexposes him to a high risk of life.12 Life belongs tothe patient, who can decide whether or not to undergoa specific health treatment. The doctor should informthe patient of the consequences of the decision that ex-poses him/her to the risk of life.It follows that any blood transfusion that is not per-mitted becomes unlawful because it violates the consti-tutional rules on freedom of conscience and theinconvertibility of individual health treatments. Con-sidering the increasingly wide application of bloodlesssurgery in clinical practice, especially in cardiac and ab-dominal surgery,13–16 and due to the lack of specificdata relating to gynecological surgery,17–19 this studyaimed to analyze the effects of preoperatory manage-ment in specific blood products refusing patientsscheduled for gynecological surgery. Therefore, ourstudy reported our experiences related to the impactof an integrated strategy to minimize the risk of severeanemia in specific populations.20Materials and MethodsBlood products refusing patients scheduled for gyneco-logical surgery were identified and screened before sur-gery between January 2016 and June 2022 at thegynecological division of the S. Andrea Hospital, Sapi-enza University of Rome, starting from digitalizingclinical data.Inclusion criteria were age >18 years and signed re-fusal of blood products.Exclusion criteria were previous surgery in the lastyear, iron deficiency without iron store replacement,myelodysplasia, myeloid cancers, ore pure red cell aplasia,uncontrolled hypertension, and history of thrombosis.The study included 83 patients. All patients haveexpressed their willingness not to receive blood trans-fusions and products and signed a detailed informedconsent.All patients were subjected to a careful clinical eval-uation and preoperative planning based on differentpoints to search for risk factors and unrecognizedpathologies.- Anamnestic evaluation: The history of anemia,hereditary or acquired bleeding disorders, con-comitant diseases, and careful assessment of thepharmacological history were evaluated.- Investigate the manifestations of the disease ma-terially associated with hemostatic dysfunctions(purpura, petechiae, ecchymosis, hepatomegaly,and splenomegaly).- Specific laboratory tests: The risk of anemia withcomplete blood count and martial structures(serum ferritin receptor and transferrin receptorand estimation of bleeding risk by evaluation ofcoagulation factors and more detailed studies toidentify coagulation disorder including specifictests for coagulation factors if risk factors) wereassessed.Our department developed a preoperative optimiza-tion protocol for patients refusing blood products, in-cluding oral iron and vitamin supplementation (folicacid and B12). The patients who did not perform orCaserta, et al.; Women’s Health Reports 2024, 5.1http://online.liebertpub.com/doi/10.1089/whr.2023.0156347refused treatment were included in the control group(group 2). Therefore, patients were divided into twogroups: 42 patients (group 1) in the 30 days before sur-gery were administered daily 1 tablet of oral iron(325 mg ferrous sulfate), 5 mg of folic acid, and vitaminB12 (methylcobalamin 1000 mcg). Group 2 (41 patients)did not receive any therapy. All included patients had astarting hemoglobin (Hb) between 10.8 and 14.3 g/dL.The institutional review board (IRB) approval of theS. Andrea Hospital—Sapienza University of Rome wasobtained and a careful informed consent was signed byeach patient enrolled in the study protocol.Statistical analysis was performed using SPSS version26.0 (SPSS, Inc., Chicago, IL). Data are expressed asmean (–standard deviation) or as proportion (percent-age, %). The changes in Hb levels were assessed withanalysis of variance. Pearson chi-square test was usedto assess the difference in proportions. A p-value<0.05 was considered statistically significant.ResultsA total of 83 patients’ afferent at the gynecology depart-ment of the hospital S. Andrea were included betweenJanuary 2016 and June 2022. Preoperative patient char-acteristics are described in Table 1. All the blood prod-ucts refusing patients were Jehovah’s Witness.In 43.4% of cases, patients were selected for surgicalprocedure for abnormal uterine bleeding, 25.1% forfibromatosis, 12% for benign adnexal disease, 3.6%for a tumor diagnosis, and 12% of cases for endometrialpathology (polyp, dysplasia) detected. The surgery pro-cedure performed were 22 hysterectomies, 15 myomec-tomies, 30 hysteroscopies, 13 interventions in theannex site, 2 vulvar surgery, and 1 uterine revision.The main complications were one severe with acutebleeding, treated with uterine artery embolization,and five minor complications (three hyperpyrexia trea-ted with paracetamol and two surgical site infections).The gynecological division of S. Andrea Hospitalmanaged preoperative optimization of the patient’s Hb.The patients were divided into two groups. Forty-twoof the patients received preoperative iron, folic acid,and vitamin B12 therapy in the 30 days before the surgi-cal procedure (Group 1), whereas 41 received no therapy(group 2). The Hb value was assessed at the beginning ofthe study, the day before surgery, and after surgery.Comparing group 1 and group 2 Hb presurgical val-ues (13.7 – 0.49 vs. 13.3 – 0.28; p = 0.0768) and postsur-gical values (13.3 – 0.28 vs. 12.17 – 0.57; p = 0.9453) andthe values of the individual groups (group 1: 13.7 – 0.49vs. 13.3 – 0.28; p = 0.4805; group 2: 13.3 – 0.28 vs.12.17 – 0.57; p = 0.0790), no significant statistical differ-ence was found (Table 2). No difference in the twostudy groups was found in Hb values before and aftersurgery after treatment.Furthermore, no differences were found by stratifyingthe value by type of intervention. Comparing the pre-and postoperative Hb values in the two study groups,no statistically significant differences were found, stratify-ing for the different types of intervention such as hyster-ectomy ( p = 0.915; p = 0.295), myomectomy ( p = 0.902;p = 0.435), hysteroscopy ( p = 0.932; p = 0.531), and inter-ventions in the annex site ( p = 0.773; p = 0.778) (Table 3).Of the 83 patients who had ‘‘bloodless’’ gynecologicalsurgery at S. Andrea University between January 2016and June 2022, none died before hospital discharge orwithin the 90-day follow-up.Depending on the clinical case, all procedures wereimplemented during the surgical procedure to mini-mize the risk of bleeding. Acute normovolemic modu-lation (depending on Hb values), performed in 8interventions, intraoperative recovery of blood per-formed in 14 interventions, the use of minimally inva-sive surgical techniques in 42 surgical procedure, andtopical hemostatic agents and electrocoagulation ele-ments performed in all the intervention, has allowed,in most cases, to control and minimize bleeding.Relating to the complications detected, a single se-vere complication after a multiple myomectomy hasbeen found. Severe anemia at the end of the surgicalprocedure was managed through uterine vessel embo-lization by an interventional radiology unit, determin-ing a resolution of bleeding. The Hb values improvedfrom 5.4 g/dL on the postoperative day to 7.8 g/dL onregistration (on the 12th day). The average numberof days of hospitalization was 1 day for minor surgeryperformed in day surgery (hysteroscopy, vulvar sur-gery, and uterine revision).Major surgery was 3.1 days for a hysterectomy, 3.4days for a myomectomy, and 2.1 days for interventionsin the annex site. Concerning the side effects reportedafter preoperative therapy, four patients reportedmild abdominal or stomach pain, two registered nau-sea, and one notified constipation. No patients stoppedtherapy during the study period.DiscussionThis retrospective study reported no difference in thetwo patient groups analysed. No significant differencein haemoglobin levels between patients who performedCaserta, et al.; Women’s Health Reports 2024, 5.1http://online.liebertpub.com/doi/10.1089/whr.2023.0156348Table 1. Patients’ CharacteristicsPatients’ characteristics (n) Total: Mean (–SD)/n (%) Group 1 n:42 Group 2 n:41 pAge 51.78 – 12.02 (30–82) 52.11 – 13.9 (30–82) 51.91 – 11.53 (34–82) 0.943Parity0 20 (24.1%) 7 (16.6%) 13 (31.7%) 0.0541 28 (33.7%) 12 (28.6%) 16 (39%)>2 35 (42.2%) 23 (54.8%) 12 (29.3%)SmokeYes 44 (53%) 29 (69.1%) 15 (36.6%) 0.030No 39 (47%) 13 (30.9%) 26 (63.4%)DiabetesNo 65 (78.3%) 40 (95.2%) 15 (36.6%) 0.001Yes 18(21.7%) 2 (4.7%) 16 (39%)HypertensionNo 61 (73.5%) 25 (59.5%) 36 (87.8%) 0.076Yes 22 (26.5%) 17 (40.4%) 5 (2.2%)DyslipidemiaNo 65 (78.3%) 34 (80.9%) 31 (75.6%) 0.745Yes 18 (21.7%) 8 (19%) 10 (24.4%)Previous cardiovascular eventNo 79 (95.2%) 38 (90.5%) 41 (100%) 0.270Yes 4(4.8%) 4 (9.5%) 0DysthyroidNo 72 (86.7%) 33 (78.6%) 39 (16.6%) 0.057Yes 11 (13.3%) 9 (21.4%) 2 (4.8%)Previous surgery 40 (48.2%) 18 (42.8%) 22 (53.6%)No 0.054Abdominal surgery 26 (31.3%) 16 (38.1%) 10 (24.4%)No abdominal surgery 17 (15.7%) 7 (16.6%) 10 (24.4%)SymptomatologyNone 5 (6%) 4 (9.5%) 1 (2.4%) 0.316Dysmenorrhea 2 (2.4%) 0 2 (4.8%)Pelvic pain 23 (27.7%) 13 (30.9%) 10 (24.4%)AUB 53 (63.9%) 25 (59.5%) 28 (16.6%)Cause of surgery 0.165AUB 36 (43.4%) 14 (33.3%) 22 (53.6%)Fibromatosis 21 (25.1%) 11 (26.2%) 10 (24.4%)Ovarian cyst 10 (12%) 8 (19%) 2 (4.8%)Endometrial disease 10 (12%) 6 (14.3%) 4 (9.7%)Cancer 3 (3.6%) 1 (2.3%) 2 (4.8%)Miscarriage 2 (2.4%) 2 (4.7%) 0Endometriosis 1 (1.2%) 0 1 (2.4%)Surgery procedureHysterectomy 22 (26.5%) 8 (19%) 14 (16.6%) 0.010Myomectomy 15 (18,2%) 8 (19%) 7 (16.6%)Hysteroscopy 30 (36.1%) 14 (33.3%) 16 (39%)Interventions in the annex site 13 (15.6%) 7 (16.6%) 6 (16.6%)Vulvar surgery 2 (2.4%) 2 (4.7%) 0RCU 1 (1.2%) 1 (2.3%) 0AUB, abnormal uterine bleeding; SD, standard deviation.Table 2. Pre- and Postoperative Comparison of Hemoglobin ValuesMean (–SD) pHb at start of the study 12.91 – 0.88 (10.6–14.4)Hb pre (total population) 13.03 – 0.86 (10.8–14.3)Hb post (total population) 12.04 – 1.67 (5.4–14.3)Hb pre vs. Hb post (group 1) 13.7 – 0.49(10.8–13.2) vs. 13.3 – 0.28(5.4–14.0) 0.4805Hb pre vs. Hb post (group 2) 13.3 – 0.28 (12.6–14.1) vs. 12.17 – 0.57 (9.8–10.3) 0.0790Hb pre (group 1) vs. Hb pre (group 2) 13.7 – 0.49(10.8–13.2) vs. 13.3 – 0.28 (12.6–14.1) 0.0768Hb post (group 1) vs. Hb post (group 2) 13.3 – 0.28(5.4–14.0) vs. 12.17 – 0.57 (9.8–10.3) 0.9453Hb, hemoglobin.349pre-operative therapy with iron, folic acid and vitamin Bcompared with patients who did not receive treatment.We considered a number of generic, medical, and sur-gical variables. In 2021, *2.9 million blood transfu-sions were performed in Italy (data from the ministryof health).In addition, the blood transfusion or its componentsmay pose a risk to the recipient related to the appear-ance of both immediate and late undesirable reactions.Because the possible risks are not always predictable,transfusion therapy should be prescribed only aftercarefully analysing the risks and benefits associatedwith it.21 The transfusion of blood cells could be con-sidered, from an immunological point of view, a realtransplant with the possibility of rejection reactions isalso very harmful to the recipient.22It should also be considered as, for a growing subsetof patients, such procedures are not an option due topersonal preferences, religious beliefs, or biologicalconditions such as advanced sickle cell anemia withantibodies. In such circumstances, doctors may turnto a bloodless approach that avoids the need for trans-fusions. Surprisingly, such approaches, which use a va-riety of clinical and laboratory methods, have beenshown to reduce blood loss and accelerate recovery,minimize infection, and reduce the length of hospitalstays.23,24 A vital aspect of bloodless preoperative careis identifying and treating any pre-existing anemiawell before the surgical procedure.Methods range from oral iron therapy to intrave-nous iron treatment combined with erythropoiesis-stimulating agents. In our study group, no state ofsevere anemia was found in the preoperative period.These data can determine why there are no significantdifferences between treated and nontreated patients.These results follow the current literature meta-analytical data concerning iron oral administration,25especially confirming how a bloodless approach in anadequately prepared and selected population deter-mines a similar performance in the study groups.It is essential to underline that our pilot study hassome limitations, including a small study sample anda more significant risk of a type II error. In addition,a comparison with a control group that does not refuseblood products will be a target of future evaluations.Concerning informed consent, it should be notedthat in the current Italian legal system, the patienthas the choice not to receive treatment (Article 32 ofthe Constitutional Charter, Article 35 of the Code ofMedical Ethics, and Article 5 of the 1997 Oviedo Con-vention on the Rights of the Union and Biomedicine).There is a conflict between subjective assumptionsand health. The doctor must treat and respect thepatient’s decision (without any legislation, administra-tive or judicial authority, being able to change things).Great attention must be paid to the hierarchicalorder of the sources of law between the right of self-determination of the patient for the refusal to care(right to let himself die, not to want death) and theduties incumbent on the doctor who must take actionand do, according to science and conscience, every-thing possible to safeguard the patient’s health. The re-fusal to treatment (in this case, blood transfusions)must be the subject of a clearly expressed, unequivocal,current, informed, and understood manifestation.These considerations must also draw attention tohow this increases the need to implement all possiblealternatives to rejected procedures.In conclusion, there is a lack of high-quality evidencefor managing patients who refuse blood products andperform gynecological surgery.17–19 Blood transfusionis a fundamental and pivotal means of managing ahemorrhagic patient. However, considering its risks,costs, and the risk of limited blood supply, knowingTable 3. Pre- and Postoperative Comparison of Hemoglobin Values for Different Surgical ProceduresTotal population Mean (–SD) Group 1 Mean (–SD) Group 2 Mean (–SD) pHysterectomy (n) Tot: 22 8/22 14/22Hb pre 13.02 – 0.85 (10.8–14.3) 13.23 – 0.87 (11.8–14.3) 13.19 – 0.83 (12.7–14.3) 0.915Hb post 12.01 – 1.41 (5.4–14.2) 11.60 – 2.60 (5.4–13.7) 12.40 – 0.84 (11–14.2) 0.295Myomectomy (n) n = 15 8/15 7/15Hb pre 12.67 – 0.80 (10.8–14.2) 12.63 – 0.80 (10.8–13.8) 12.69 – 1.06 (11.3–14.3) 0.902Hb post 10.76 – 1.80 (5.5–13.7) 11.81 – 2.09 (9.8–13.2) 11.14 – 0.71 (10.8–14.2) 0.435Hysteroscopy (n) n = 30 14/30 16/30Hb pre 13.22 – 0.72 (11.8–14.3) 13.26 – 0.72 (11.8–14.3) 13.18 – 0.74 (12.1–14.3) 0.932Hb post 12.56 – 1.03 (10.8–14.3) 13.53 – 1.02 (10.8–14) 12.59 – 1.06 (10.8–14.2) 0.531Interventions in the annex site (n) n = 13 4/13 9/13Hb pre 12.88 – 1.11 (10.8–13.8) 12.72 – 1.20 (10.8–13.8) 12.33 – 1.05 (10.8–13.9) 0.773Hb post 12.14 – 1.43 (9.8–13.2) 11.96 – 1.51 (9.8–13.2) 11.20 – 1.78 (9.8–13.3) 0.776Caserta, et al.; Women’s Health Reports 2024, 5.1http://online.liebertpub.com/doi/10.1089/whr.2023.0156350and implementing the PBM approach as much as pos-sible are essential to guarantee the patient better andsafer clinical and care management, as underlined byour pilot study. Further well-designed randomizedstudies are required to provide further definitive infor-mation about the benefits and potential harms of pre-,intra-, and postsurgical management of gynecologicalpatients.Author Disclosure StatementNo competing financial interests exist.Funding InformationNo funding was received for this article.Reference1. WHO. Sixty-Third World Health Assembly. Availability, safety and qualityof blood. WHA63.12. Available from: https://www.who.int/publications/i/item/WHA63.12 [Accessed March 01, 2024].2. Farmer S, Towler S, Hofmann A. The Australian PBM Concept—A SuccessStory. In: Patient Blood Management. (Gombotz H, Zacharowski K, SpahnD. eds) Stuttgart: Germany; 2016; pp. 207–217.3. Isbister J. The three-pillar matrix of patient blood management. ISBT SciSeries 2015;27(1):69–84; doi: 10.1016/j.bpa.2013.02.0024. Vaglio S, Gentili S, Marano G, Pupella S, et al. The Italian RegulatoryGuidelines for the implementation of Patient Blood Management. 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Iron therapy for pre-operative anaemia.Cochrane Database Syst Rev 2019;12(12):CD011588; doi: 10.1002/14651858.CD011588.pub3Cite this article as: Caserta D, Costanzi F, De Marco MP, Besharat AR,Napoli C, Aromatario MR, Palomba S (2024) Bloodless gynecologicalsurgery in blood products refusing patients: experience of a singleinstitution, Women’s Health Reports 5:1, 346–351, DOI: 10.1089/whr.2023.0156.Abbreviations UsedAUB ¼ abnormal uterine bleedingHb ¼ hemoglobinIRB ¼ institutional review boardPBM ¼ patient blood managementPublish in Women’s Health Reports- Immediate, unrestricted online access- Rigorous peer review- Compliance with open access mandates- Authors retain copyright- Highly indexed- Targeted email marketingliebertpub.com/whrCaserta, et al.; Women’s Health Reports 2024, 5.1http://online.liebertpub.com/doi/10.1089/whr.2023.0156351

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