Radiol Oncol 2023; 57(1): 80-85. doi: 10.2478/raon-2022-0026 80 research article Does concurrent gynaecological surgery affect infectious complications rate after mastectomy with implant-based reconstruction? Nina Pislar1,2, Barbara Peric1,2, Uros Ahcan2,3, Romi Cencelj-Arnez1,2, Janez Zgajnar1,2, Andraz Perhavec1,2 1 Department of Surgical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia 2 Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia 3 Department of Plastic Surgery and Burns, University Medical Centre Ljubljana, Ljubljana, Slovenia Radiol Oncol 2023; 57(1): 80-85. Received 24 April 2022 Accepted 23 May 2022 Correspondence to: Asst. Prof. Andraz Perhavec, M.D., Ph.D., Department of Surgical Oncology, Institute of Oncology Ljubljana, Zaloška 2, SI-1000 Ljubljana, Slovenia. E-mail: aperhavec@onko-i.si Disclosure: No potential conflicts of interest were disclosed. This is an open access article distributed under the terms of the CC-BY license (https://creativecommons.org/licenses/by/4.0/). Background. Women who undergo breast cancer surgery often have an indication for gynaecological procedure. The aim of our study was to compare infectious complications rate after mastectomy with implant-based reconstruc- tion in patients with and without concurrent gynaecological procedure. Patients and methods. We retrospectively reviewed clinical records of 159 consecutively operated patients after mastectomy with implant-based reconstruction. The patients were divided in 2 groups: 102 patients without (Group 1) and 57 with (Group 2) concurrent gynaecological procedure. Infectious complications rates between the groups were compared using χ2-test. Logistic regression was performed to test for association of different variables with infec- tious complications. Results. There were 240 breast reconstructions performed. Median follow-up time was 297 days (10–1061 days). Mean patient age was 47.2 years (95% CI 32.8–65.9); 48.2 years (95% CI 46.1–50.3) in Group 1 and 45.8 years (95% CI 43.2–48.3) in Group 2; p = 0.002). Infectious complications rate was 17.6% (17.6% vs. 17.5%, p = 0.987), implant loss occurred in 5.7% (4.9% vs. 7.0%, p = 0.58). Obesity (body mass index [BMI] > 30 kg/m2), age, previous breast conserv- ing treatment (BCT) with radiotherapy (RT) were identified as risk factors for infectious complications in univariate analysis. Obesity (adjusted odds ratio [aOR] 3.319, 95% CI 1.085–10.157, p = 0.036) and BCT with RT (aOR 7.481, 95% CI 2.230–25.101, p = 0.001) were independently associated with infectious complications in multivariate model. Conclusions. Concurrent gynaecological procedure for patients undergoing mastectomy with implant-based re- construction did not carry an increased risk for infectious complications. Key words: breast cancer; infectious complications; implant-based reconstruction; concurrent surgical manage- ment; implant loss Introduction Combining a clean surgery that involves prosthetic material with a clean-contaminated surgery has always been controversial.1 Women who undergo mastectomy with implant reconstruction for risk reduction or cancer often have an indication for a gynaecological procedure.2 In premenopausal women with hormone receptor-positive tumours, ovarian suppression with surgical oophorectomy has been recognised as part of the treatment strat- egy for more than a century.3 In high-risk women, Radiol Oncol 2023; 57(1): 80-85. Pislar N et al. / Concurrent gynaecological surgery and infections after implant-based reconstruction 81 surgical intervention with prophylactic bilateral mastectomy reduces breast cancer risk by up to 95%, while bilateral salpingo-oophorectomy re- duces both breast and ovarian cancer risks by around 50% and 80%, respectively.4,5 It is also as- sociated with improved survival.6–8 When immediate implant-based breast recon- struction is planned, skin-sparing mastectomy (SSM) is most commonly performed, but nipple- sparing mastectomy (NSM) can be a safe option in selected cases.9–11 Infectious complications in implant-based re- constructions can cause prolonged antibiotic treat- ment and can result in implant removal.12,13 This may delay adjuvant treatments for breast cancer and cause scarring that can affect functional as well as aesthetic outcome. Therefore, a low infec- tious complications rate is important.14 Infectious complications rate varies between centres and is around 20%.15 Due to increased operating time and an intraab- dominal procedure, coordinated surgical manage- ment of the breast with a concurrent gynaecologi- cal procedure could increase the likelihood of in- fectious complications.16 On the other hand, com- bining the procedures adds to patient satisfaction and optimises the time and cost management.17 The aim of our study was to compare infectious complications rate after mastectomy with implant- based reconstruction in a group of patients with and without concurrent gynaecological procedure. Patients and methods Study cohort and data collection We conducted a retrospective analysis of infec- tious complications in patients after implant-based reconstruction with or without concurrent gy- naecological procedure and followed them until the date of complication, expander-prosthesis ex- change surgery, or until last follow-up visit. We retrospectively reviewed records of 159 women (and 240 breast reconstructions) that were con- secutively operated at the Institute of Oncology Ljubljana, Slovenia between February 2014 and June 2020 for a new or previously diagnosed breast cancer and/or had an increased risk for developing breast cancer, mainly due to a recognised BRCA1/2 mutation. Unilateral or bilateral mastectomy was performed, either SSM or NSM, followed by breast reconstruction with either tissue expander or pros- thesis. Fifty-seven patients had a laparoscopic gynaecological procedure (salpingectomy, oopho- rectomy, hysterectomy or a combination) during the same anaesthesia. Postoperative complications were tracked reviewing follow-up visits with sur- gical oncologist and reconstructive surgeon. We recorded infectious complications requiring the use of oral or parenteral antibiotics, infectious and wound healing complications requiring surgical treatment under general anaesthesia (necrectomy, debridement) and implant loss due to infection. Treatment protocol As part of standard treatment protocol at our cen- tre immediate reconstruction is offered after pro- phylactic or therapeutic mastectomy, either au- tologous or implant-based. Patients’ cases are dis- cussed prior to surgery at a multidisciplinary team meeting between a surgical oncologist, a radiation therapist and a reconstructive surgeon. The pa- tients are operated under general anaesthesia with perioperative antibiotic prophylaxis. Two grams of cephazolin are given for prophylaxis and the an- tibiotics are continued post-operatively, typically until drains are removed. If a gynaecological pro- cedure is planned, it is performed first, followed by breast surgery. The gynaecological procedure is performed laparoscopically. Mastectomy with or without axillary lymph node surgery is performed by a surgical oncologist, followed by the recon- structive procedure that is performed by a recon- structive surgeon. A tissue implant is inserted in a pocket, which consists of pectoralis major and serratus anterior muscle. Prior to implant inser- tion, the area is irrigated with antibiotic solution. The drainage stays in place until less than approxi- mately 50 ml discharge daily for two consecutive days. After the drains are removed and the wounds heal, tissue expanders are filled gradually with sa- line solution in an outpatient setting every two to three weeks. Statistical analysis Patients’ characteristics were compared between the two groups (with and without gynaecological procedure) with χ2 test or Fisher’s exact test for categorical variables and Student t-test for continu- ous variables. Data were reported as counts and frequencies for categorical and as median with sample range or mean with 95% confidence inter- val (CI) for continuous variables. Univariate binary logistic regression was performed to test for asso- ciation of different variables with infectious com- plications. Variables with a statistical significance Radiol Oncol 2023; 57(1): 80-85. Pislar N et al. / Concurrent gynaecological surgery and infections after implant-based reconstruction82 of p < 0.1 were included in a multivariate binary logistic regression model. Data were analysed us- ing IBM SPSS Statistics software (Statistical pack- age for the Social Sciences Statistical Software, IBM Corporation, Armonk, NY, USA). Statistical signifi- cance was set at p < 0.05. The study was reviewed and approved by the Institutional Review Board and Ethics Committee. Results In 159 patients, 240 breast reconstructions were performed with 214 tissue expanders and 26 pros- theses. All patients were women. Median follow- up time was 297 days (10–1061 days), 321 days (14–712 days) in Group 1 and 273 days (10–1061 days) in Group 2. Expander-prosthesis exchange surgery was mostly performed within a year from initial surgery, median 333.5 days (74 – 712 days). Fifty-seven patients (35.8%) had a concurrent laparoscopic gynaecological procedure (Group 2). These patients were younger at the time of surgery (Group 1 48.2 years, 95% CI 46.1–50.3 vs. Group 2 45.8 years, 95% CI 43.2–48.3, p = 0.002) and more likely to have been previously treated with breast conserving therapy (BCT) including radiotherapy (RT) for breast cancer (Group 1 7.8% vs. Group 2 36.8%, p = 0.001). Patients without combined proce- dures (Group 1) were more likely treated with neo- adjuvant chemotherapy (NACT) (21.6% vs. 5.3%, p = 0.007) and more likely received adjuvant RT (31.4% vs. 5.3%, p = 0.001). We present the patients’ characteristics in Table 1. TABLE 1. Patients characteristics Variable All Group 1 Group 2 p N = 159 N = 102 (64.2%) N = 57 (35.8%) Age (years) 47.2 (95% CI 32.8–65,9) 48.2 (95% CI 46.1–50.3) 45.8 (95% CI 43.2–48.3) 0.002 BMI (kg/m2) 24.7 (95% CI 18.9–34,8) 24.4 (95% CI 23.4–25.4) 25.8 (95% CI 24.1–27.4) 0.189 Smoking 37 (23.3%) 22 (21.6%) 15 (26.3%) 0.497 Diabetes mellitus 3 (1.9%) 3 (2.9%) 0 0.191 ASA score 0.622 1 31 (19.5%) 24 (23.5%) 7 (12.3%) 2 80 (50.3%) 56 (54.9%) 24 (42.1%) 3 11 (6.9%) 7 (6.9%) 4 (7.0%) Unknown 37 (23.3%) 15 (14.7%) 22 (38.6%) Previous BCT with RT 29 (18.2%) 8 (7.8%) 21 (36.8%) 0.001 NACT 25 (15.7%) 22 (21.6%) 3 (5.3%) 0.007 Adjuvant RT 35 (22.0%) 32 (31.4%) 3 (5.3%) 0.001 ACT 33 (20.8%) 23 (22.5%) 10 (17.5%) 0.455 Group 1: Patients without gynaecological procedure; Group 2: Patients with gynaecological procedure. ACT = adjuvant chemotherapy; ASA = American Society of Anaesthesiology; BC = breast cancer; BCT = breast conserving therapy; BMI = body mass index; NACT = neoadjuvant chemotherapy; RT = radiotherapy TABLE 2. Surgical site infections after implant reconstruction All (%) Group 1 (%) Group 2 (%) p-value All* 28 (17.6) 18 (17.6) 10 (17.5) 0.987 Surgical intervention needed** 13 (8.2) 8 (7.8) 5 (8.8) 0.84 Implant loss*** 9 (5.7) 5 (4.9) 4 (7.0) 0.58 Group 1: Patients without gynaecological procedure; Group 2: Patients with gynaecological procedure. *all surgical site infectious complications requiring oral or i.v. antibiotic, surgical debridement under general anaesthesia or implant removal surgery**surgical intervention requiring general anaesthesia ***tissue-expander or prosthesis removal due to infection. Radiol Oncol 2023; 57(1): 80-85. Pislar N et al. / Concurrent gynaecological surgery and infections after implant-based reconstruction 83 Overall infectious complication rate in our co- hort of 159 women was 17.6% and did not signifi- cantly differ between the groups (17.6% vs. 17.5%, p = 0.987). Tissue implants had to be removed due to infection in 5.7% (4.9% vs. 7.9%, p = 0.58). We present the comparison between groups in Table 2. Several covariates were tested for association with overall infectious complications in the en- tire cohort. Obesity (body mass index [BMI] > 30 kg/m2), age and previous BCT with RT for breast cancer were identified as risk factors for infec- tious complications. Concurrent gynaecological procedure, smoking, diabetes, American Society of Anaesthesiology (ASA) score, neo-/adjuvant systemic therapy and adjuvant RT were not sig- nificantly associated with infectious complications (Table 3). Age at the time of surgery, BMI and previous BCT with RT were included in the multivariate model. Obesity (BMI > 30 kg/m2) and previous BCT with RT were independently associated with infec- tious complications. Women with a history of BCT and RT for breast cancer had approximately three times higher odds for infectious complications compared to those without previous BCT with RT (adjusted odd ratio [aOR] 3.319, 95% CI 1.085– 10.157, p = 0.036). Obese patients (BMI > 30 kg/m2) had about 7.5-times higher odds for infectious complications compared to women who had a BMI in the normal range between 19 and 25 kg/m2 (aOR 7.481, 95% CI 2.230–25.101, p = 0.001) (Table3). Discussion In presented retrospective single centre series of 159 women, who underwent mastectomy with implant-based reconstruction there was no asso- ciation between infectious complications rate and concurrent gynaecological procedure. The results are consistent with other studies. In a group of seventy breast cancer patients that under- went laparoscopic oophorectomy, among which 29 had a concurrent breast surgery, Willshire et al. have shown it is safe to carry out the gynaeco- logical procedure in a combined setting. However, only four patients in this cohort had mastectomy with implant-based reconstruction and the focus on postoperative complications was the gynaeco- logical procedure.2 For 62 high-risk women that opted for breast and ovarian risk-reducing sur- gery, post-operative complications rate was no different between sequential vs. coordinated surgi- cal management. The study included autologous reconstructions.18 Furthermore, a new approach has been described for performing laparoscopy via a transmammary route to improve aesthetic out- come and avoid abdominal scars.19 In a recently published study, the rates of post- operative complications for implant-based recon- structions were comparable between 141 patients with concurrent gynaecological and 29 patients without gynaecological procedure.20 The complica- tions only represent the perioperative period, but the sample size is comparable to our study. Overall, infectious complications rate in our co- hort was 17.6% and implant loss occurred in 5.7%. In a recent case series of 16 patients with coordi- nated surgical management, a 37% 30-day postop- erative complication rate was observed, but minor complications, such as seroma and excessive drain- age were also included.21 In a subgroup of 19 co- ordinately managed patients with implant-based reconstruction, implant loss was observed in two women (11%). In larger series, implant loss rates are comparable to our centre.22 TABLE 3. Variables associated with infectious complications Variable OR P aOR p Gynaecological procedure 1.116 (0.486–2.564) 0.796 NA NA BMI < 25 1 1 25–30 3.000 (0.974–9.239) 0.056 2.552 (0.777–8.382) 0.122 > 30 8.100 (2.540–25.826) < 0.001 7.481 (2.230–25.101) 0.001 Age > 45 2.707 (1.118–6.552) 0.027 1.939 (0.497–3.907) 0.529 Smoking 1.061 (0.413–2.724) 0.903 NA NA Diabetes 2.286 (0.200-26.094) 0.506 NA NA ASA 1 1 2 1.821 (0.560-5.921) 0.319 NA NA 3 0.675 (0.067-6.789) 0.739 NA NA Previous BCT with RT 3.802 (1.546-9.354) 0.004 3.319 (1.085–10.157) 0.036 NACT 0.345 (0.076-1.553) 0.165 NA NA ACT 0.995 (0.369-2.687) 0.992 NA NA Adj. RT 0.909 (0.338-2.442) 0.849 NA NA aOR = adjusted odds ratio; ASA = American Society of Anaesthesiology; ACT = adjuvant chemotherapy; BC = breast cancer; BCT = breast conserving therapy; BMI = body mass index; NACT = neoadjuvant chemotherapy; RT = radiotherapy Radiol Oncol 2023; 57(1): 80-85. Pislar N et al. / Concurrent gynaecological surgery and infections after implant-based reconstruction84 In our study, patients in the two groups were different for age, history of BCT with RT, NACT and adjuvant RT. Patients that had combined pro- cedures were younger, which is consistent with the fact that gynaecological risk reduction surgery has greater survival gain if performed earlier.23 A higher proportion of women with a history of BCT in Group 2 is also reasonable, as they would more often have an indication for either endocrine or prophylactic gynaecological procedure.2 Obesity, defined as BMI > 30 kg/m2 is an estab- lished risk factor for surgical site infection and our study results are in accordance with this.12,24 Confidence intervals are relatively large due to low absolute number of obese patients in our study co- hort. We can explain the low numbers with the fact that obese patients are more often advised against breast reconstruction at the multidisciplinary team meeting. They often have other comorbidities that can be associated with complications during and after surgery. The association with obesity in our study is statistically significant and displays more than seven times higher odds for infectious com- plications compared to baseline BMI. Obesity is also a risk factor for implant loss and reduces self- image after reconstructive procedure.25 Similar is known for age; however, the effect in our cohort was small in univariate and lost in multivariate analysis. This could be because median age was below 50 years and patients in our cohort did not have many comorbidities. Smoking has also been recognised as a risk factor for complications, but in our cohort, no association was observed. The data on smoking was inconsistent due to retrospective data recollection and loose definition of smoking status. A history of BCT with RT has been associated with an increased complication rate after tissue expander surgery in previous studies and our study shows similar results.26,27 Postoperative RT is also often recognised as a risk factor for infection and implant loss.15,28 In a large systematic review, Momoh et al. reported no difference in reconstruc- tion failure rates between patients with a history of BCT with RT and postoperative RT.29 In our cohort, adjuvant RT was not associated with an increased risk for infectious complications. In univariate analysis, it even displayed a protective effect, al- though not statistically significant, and was there- fore not included in the multivariate analysis. Neither NACT nor adjuvant chemotherapy were associated with infectious complications and the results are consistent with other studies.30 In a large meta-analysis, NACT was shown to slightly increase implant loss rates, but no delay in starting adjuvant treatment was observed.31 The main limitation of our study is retrospective data collection, including quality of data and selec- tion bias. Patients that were at higher risk for com- plications, were more likely advised against co- ordinated surgical management in the first place. Sample size was sufficient, but small numbers in subcategories resulted in large confidence inter- vals. The study was conducted at the only referral centre for breast cancer cases requiring reconstruc- tion in Slovenia. Follow-up is continued in the out- patient setting and patients are seldom lost during follow-up. Other strengths of the study are recent data and a long follow-up time; most patients have been followed until expander-prosthesis exchange surgery. Concurrent laparoscopic gynaecological pro- cedure for patients undergoing mastectomy with implant-based reconstruction was safe and did not carry an increased risk for postoperative infectious complications. Obesity and previous BCT with RT were independent risk factors for infectious com- plications. Acknowledgments The authors acknowledge the financial support from the Slovenian Research Agency (research core funding No. P3-0352 (C). References 1. Altemeier W, Burke J, Pruitt B, Sandusky W. Manual on control of infection in surgical patients. 2nd edition. Philadelphia: JB Lippincott; 1984. 2. Willsher P, Ali A, Jackson L. Laparoscopic oophorectomy in the manage- ment of breast disease. ANZ J Surg 2008; 78: 670-2. doi: 10.1111/j.1445- 2197.2008.04614.x 3. McDonald Wade S, Hackney MH, Khatcheressian J, Lyckholm LJ. 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