A New Technique for Pelvic and Vaginal Reconstruction in Abdominoperineal Rectal Excision: Combination of Gluteus Maximus Flap and Fasciocutaneous Flap.

Resection of advanced rectal cancer might result in significant tissue loss, including pelvic floor and parts of the vaginal wall. Pelvic floor reconstruction using a musculocutaneous flap offers optimized healing abilities and the possibility of vaginal reconstruction. In Skåne University Hospital, two different flap techniques are used to reconstruct the perineum: the vertical rectus abdominis musculocutaneous flap and the gluteus maximus (GM) flap. A combination of a GM flap and a fasciocutanous flap, referred to locally as a GM special (GMS) flap, is used for posterior vaginal wall reconstruction in women undergoing abdominoperineal resections including parts of or the total posterior vaginal wall. The GMS flap was introduced through a national collaboration in Sweden in 2013. The aim of this article is to offer a detailed description and illustrations of the surgical technique used to construct the GMS flap, focusing on the posterior vaginal wall reconstruction. In our experience, the GMS flap is a resilient and cosmetically appealing choice that is technically easily harvested. The flap has acceptable morbidity and long-term results with adequate neovaginal measurements. Collaborative work is further encouraged.

Effectiveness of Single vs Multiple Doses of Prophylactic Intravenous Antibiotics in Implant-Based Breast Reconstruction: A Randomized Clinical Trial.

Importance: Multiple-dose antibiotic prophylaxis is widely used to prevent infection after implant-based breast reconstruction despite the lack of high-level evidence regarding its clinical benefit. Objective: To determine whether multiple-dose antibiotic prophylaxis is superior to single-dose antibiotic prophylaxis in preventing surgical site infection (SSI) after implant-based breast reconstruction. Design, Setting, and Participants: This prospective, multicenter, randomized clinical superiority trial was conducted at 7 hospitals (8 departments) in Sweden from April 25, 2013, to October 31, 2018. Eligible participants were women aged 18 years or older who were planned to undergo immediate or delayed implant-based breast reconstruction. Follow-up time was 12 months. Data analysis was performed from May to October 2021. Interventions: Multiple-dose intravenous antibiotic prophylaxis extending over 24 hours following surgery, compared with single-dose intravenous antibiotic. The first-choice drug was cloxacillin (2 g per dose). Clindamycin was used (600 mg per dose) for patients with penicillin allergy. Main Outcomes and Measures: The primary outcome was SSI leading to surgical removal of the implant within 6 months after surgery. Secondary outcomes were the rate of SSIs necessitating readmission and administration of intravenous antibiotics, and clinically suspected SSIs not necessitating readmission but oral antibiotics. Results: A total of 711 women were assessed for eligibility, and 698 were randomized (345 to single-dose and 353 to multiple-dose antibiotics). The median (range) age was 47 (19-78) years for those in the multiple-dose group and 46 (25-76) years for those in the single-dose group. The median (range) body mass index was 23 (18-38) for the single-dose group and 23 (17-37) for the multiple-dose group. Within 6 months of follow-up, 30 patients (4.3%) had their implant removed because of SSI. Readmission for intravenous antibiotics because of SSI occurred in 47 patients (7.0%), and 190 women (27.7%) received oral antibiotics because of clinically suspected SSI. There was no significant difference between the randomization groups for the primary outcome implant removal (odds ratio [OR], 1.26; 95% CI, 0.69-2.65; P = .53), or for the secondary outcomes readmission for intravenous antibiotics (OR, 1.18; 95% CI, 0.65-2.15; P = .58) and prescription of oral antibiotics (OR, 0.72; 95% CI, 0.51-1.02; P = .07). Adverse events associated with antibiotic treatment were more common in the multiple-dose group than in the single-dose group (16.4% [58 patients] vs 10.7% [37 patients]; OR, 1.64; 95% CI, 1.05-2.55; P = .03). Conclusions and Relevance: The findings of this randomized clinical trial suggest that multiple-dose antibiotic prophylaxis is not superior to a single-dose regimen in preventing SSI and implant removal after implant-based breast reconstruction but comes with a higher risk of adverse events associated with antibiotic treatment. Trial Registration: EudraCT 2012-004878-26.

Vaginal reconstruction using a gluteal transposition flap after abdominoperineal excision for anorectal malignancy.

The purpose of this study is to present and evaluate a surgical method using gluteal flap for combined perineal and vaginal reconstruction after abdominoperineal excision (APE) with partial vaginectomy for anorectal malignancy. The method is a two-centre study of consecutive patients undergoing APE including partial vaginectomy for anorectal tumours, with immediate combined perineal and vaginal reconstruction using gluteal flaps. Follow-up data were retrieved via retrospective review of medical records, questionnaires and gynaecological examinations. Some 34 patients fulfilled the inclusion criteria. At the time of follow-up, 14 (78%) of the 18 patients alive responded to questionnaires. Seven (50%) of the survey responders agreed to undergo gynaecological examination. Major flap-specific complications (Clavien-Dindo > 2) were observed in 3 (9%) patients. Among survey responders, 11 (79%) had been sexually active preoperatively of which five (45%) resumed sexual activity postoperatively and three (27%) resumed vaginal intercourse. These three patients had all implemented an active vaginal health promotion strategy postoperatively. Perineo-vaginal reconstruction using gluteal flap after extended APE for anorectal malignancy is feasible. Although comparable to other methods of reconstruction, the rate of perineo-vaginal complications is high and post-operative sexual dysfunction is substantial. Postoperative strategies for vaginal health promotion may improve sexual function after vaginal reconstruction.

Effect of Immediate Implant-Based Breast Reconstruction After Mastectomy With and Without Acellular Dermal Matrix Among Women With Breast Cancer: A Randomized Clinical Trial.

Importance: The use of acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) is established practice. Existing evidence validating ADMs proposed advantages, including improved cosmetics and more single-stage IBBRs, is lacking. Objective: To evaluate whether IBBR with ADM results in fewer reoperations and increased health-related quality of life (HRQoL) compared with conventional IBBR without ADM. Design, Setting, and Participants: This was an open-label, multicenter, randomized clinical trial of women with primary breast cancer who planned for mastectomy and immediate IBBR, with a 2-year follow-up for all participants. Participants were enrolled at 5 breast cancer units in Sweden and the United Kingdom between 2014 and May 2017. Exclusion criteria included previous radiotherapy and neo-adjuvant chemotherapy. Data were analyzed until August 2017. Interventions: Participants were allocated to immediate IBBR with or without ADM. Main Outcomes and Measures: The primary trial end point was number of reoperations at 2 years. HRQoL, a secondary end point, was measured as patient-reported outcome measures using 3 instruments from the European Organization for Research and Treatment of Cancer Quality of life Questionnaire. Results: From start of enrollment on April 24, 2014, to close of trial on May 10, 2017, a total of 135 women were enrolled (mean [SD] age, 50.4 [9.5] years); 64 were assigned to have an IBBR procedure with ADM and 65 to the control group who had IBBR without ADM. There was no statistically significant difference between groups for the primary outcome. Of 129 patients analyzed at 2-year follow-up, 44 of 64 (69%) had at least 1 surgical event in the ADM group vs 43 of 65 (66%) in the control group. In the ADM group, 31 patients (48%) had at least 1 reoperation on the ipsilateral side vs 35 (54%) in the control group. The overall number of reoperations on the ipsilateral side were 42 and 43 respectively. Within the follow-up time of 24 months, 9 patients (14%) in the ADM group had the implant removed compared with 7 (11%) in the control group. We found no significant mean differences in postoperative patient-reported HRQoL domains, including perception of body image (mean difference, 3; 99% CI, -11 to 17; P = .57) and satisfaction with cosmetic outcome (mean difference, 8; 99% CI, -6 to 20; P = .11). Conclusions and Relevance: Immediate IBBR with ADM did not yield fewer reoperations compared with conventional IBBR without ADM, nor was IBBR with ADM superior in terms of HRQoL or patient-reported cosmetic outcomes. Patients treated for breast cancer contemplating ADM-supported IBBR should be informed about the lack of evidence validating ADM's suggested benefits. Trial Registration: ClinicalTrials.gov Identifier: NCT02061527.

Complications after pressure ulcer surgery - a study of 118 operations in spinal cord injured patients.

Our aim in this study was to examine which factors are associated with post-operative complications after surgery for pressure ulcers in individuals with spinal cord injury. We performed a retrospective cohort study including all spinal cord injured patients undergoing pressure ulcer surgery in our department between 2002 and 2019. Patient demographics and comorbidity were collected from medical records, as were treatment data and information on post-operative complications within 30 days. Assessment of outcomes was performed through t-tests, χ2-tests and ANOVA. Out of 118 operations, 51 (43%) had a post-operative complication of any kind. The vast majority (44 cases, 86% of all complications) had minor complications (Clavien-Dindo grade I or II). Seven patients (6%) had a complication of Clavien-Dindo grade III or higher, requiring return to theatre or ICU care. We found that a higher age, a low serum albumin (<3.5 g/dl), and over or underweight, were associated with an increased risk of complications (p < 0.05). Out of 143 treated ulcers, 132 were evaluated at a follow-up visit one to two months after surgery, and 99 of these (75%) were healed. Surgery of pressure ulcers in patients with spinal cord injury is not a low-risk venture, however, few patients will suffer serious post-operative complications. A majority of treated ulcers will heal shortly post-operatively. A number of risk factors are associated with post-operative complications, which can be of help to guide patient selection in the future.

Implant Based Breast Reconstruction With Acellular Dermal Matrix: Safety Data From an Open-label, Multicenter, Randomized, Controlled Trial in the Setting of Breast Cancer Treatment.

OBJECTIVE: To evaluate clinical outcomes of using acellular dermal matrix (ADM) with implant based breast reconstructions (IBBRs) in a randomized controlled trial. SUMMARY BACKGROUND DATA: The use of ADMs in IBBRs is widespread, but link between ADM and complications remain a controversial topic. In view of reports concerning harm, we present 6-months safety data of ADM-assisted IBBR in the setting of breast cancer treatment. METHODS: An open-label, randomized, controlled trial recruiting patients from 4 centers in Sweden and 1 in UK. Eligible were women with breast cancer planned for mastectomy with immediate IBBR. Participants were randomly allocated to IBBR with or without ADM (Strattice, Branchburg, NJ), with stratification by center in blocks of 6. Main primary endpoint was number of unplanned reoperations at 24 months, and safety expressed as the incidence of adverse events with a 6-month follow-up time for all participants. Analysis were done per protocol using Fisher exact test for complications and reoperations. RESULTS: From start of enrolment on April 24, 2014, to close of trial on May 10, 2017, 135 women were enrolled, of whom 64 with ADM and 65 without ADM were included in the final analysis. Four patients (6%) in each group had reconstructive failure with implant loss, but IBBR with ADM exhibited a trend of more overall complications and reoperations (difference 0·16, 95% CI, -0·01 to 0·32, P = 0·070), and with higher risk of wound healing problems (P = 0·013). CONCLUSIONS: With 6-months follow-up for all participants, immediate IBBR with ADM carried a risk of implant loss equal to conventional IBBR without ADM, but was associated with more adverse outcomes requiring surgical intervention. Further investigation of risk factors and patient selection in a long-term follow-up is warranted.

Surgery for pressure ulcers in spinal cord-injured patients following a structured treatment programme: a 10-year follow-up.

With the aim to improve the outcomes for spinal cord-injured patients undergoing surgery for pressure ulcers, a structured treatment programme regulating pre- and postoperative care and rehabilitation was introduced in 2002 in Stockholm. Fifty-one consecutive patients operated on between 2002 and 2007 were included in a 10-year follow-up to evaluate the programme regarding initial healing results and long-term ulcer and health status. At one month postoperatively, 49 out of 51 (96%) patients were completely healed. Five patients (5/44, 11%) developed recurrent or new ulcers within 3 years of surgery. Two patients were re-operated on (2/44, 5%). Between 3 and 10 years after surgery, 9 patients (9/33, 27%) had a history of recurrent ulcers, and 6 (6/33, 18%) had a history of new ulcers, a total of 15 patients (15/33, 45%). Of these, three needed re-operation (3/33, 9 %). The health status values using a visual analogue rating scale were 70 (median) at 3 and 10 years compared with 30 (median) preoperatively. The good initial healing, the low ulcer recurrence rate and the raise in health status indicate the value of a structured treatment programme, especially for the first few postoperative years.

Radiotherapy in implant-based immediate breast reconstruction: risk factors, surgical outcomes, and patient-reported outcome measures in a large Swedish multicenter cohort.

The purpose of this large cohort study was to analyze the effects of prior and postoperative radiotherapy (RT) on surgical outcomes and patient-reported outcome measures (PROMs) in implant-based immediate breast reconstruction (IBR). All breast cancer patients (n = 725, of whom 29 had bilateral IBR) operated with implant-based IBR at four Stockholm hospitals from 2007 to 2011 were included. The median follow-up was 43 months. Three groups were compared: no RT (n = 386), prior RT (n = 64), and postoperative RT (n = 304). Outcomes were IBR failure (implant loss with or without secondary autologous reconstruction), unplanned reoperations, and PROMs, as measured by the BreastQ(®) questionnaire. IBR failure occurred in 22/386 (6 %) of non-irradiated cases, 16/64 (25 %) after prior and 45/304 (15 %) after postoperative RT (p < 0.001). Failure risk was higher after prior than postoperative RT (HR 9.28 vs. 3.08). Further risk factors were high BMI, less surgeon reconstructive experience, and postoperative infection, while the use of permanent implants lowered the risk of IBR failure. The estimated 5 years IBR failure rate was 10.4 % for non-irradiated, 28.2 % for previously and 25.2 % for postoperatively irradiated patients (p < 0.001). At least one unplanned reoperation occurred in 169/384 of non-irradiated (44 %), 42/64 (66 %) of previously, and 180/303 (59 %) of postoperatively irradiated breasts (p < 0.001). Further contributing factors were the use of one-stage expander and permanent implants, less surgeon reconstructive experience, and smoking. RT significantly impaired scores on all scales of the BreastQ(®). However, a clear majority of women in all groups would choose IBR again. Implant-based IBR remains a feasible option for women undergoing mastectomy as patient satisfaction levels are high. After prior RT, however, autologous alternatives should be considered.

Sensation Following Immediate Breast Reconstruction with Implants.

Sensation is a neglected aspect of the outcome of breast reconstructions with implants. The aim of this prospective study was to evaluate the cutaneous somatosensory status in breasts following mastectomy and immediate reconstruction with permanent adjustable prostheses and to analyze the patients' subjective experience of the sensation. Twenty-four consecutive patients diagnosed with invasive or in situ breast carcinoma were examined preoperatively and 2 years after mastectomy and reconstruction, for assessment of perception thresholds for touch, cold, warmth, and heat pain above and below the areola. Von Frey filaments and a Peltier element-based thermode were used. The patients completed a questionnaire concerning their experienced sensation in the reconstructed breast. Using quantitative somato-sensory testing, the sensation to all the examined modalities was significantly impaired compared to preoperatively. Most affected was the area above the areola. Patients given postoperative radiotherapy (n = 9) did not differ from those without radiotherapy (n = 15) regarding any of the modalities. All patients reported reduced sensation in the reconstructed breast compared to that preoperatively. Twenty-three patients stated that the reconstructed breast felt different from the other breast; nevertheless 16 reported that the reconstructed breast felt like a real breast. The study revealed sensation impairment following mastectomy and immediate reconstruction with implants. Patients should be informed about this effect preoperatively to allow adequate expectations regarding the sensation outcome. However, two-thirds of the study patients considered that the reconstructed breast felt like a real breast, which must be one of the main purposes of a breast reconstruction.

Long-term sensibility following nonautologous, immediate breast reconstruction.

Immediate breast reconstruction after mastectomy, using submuscular expander prostheses, is well established in the treatment of breast cancer. The aim of this study was to survey the postoperative cutaneous somatosensory status and to analyze the patients' subjective opinion about the sensibility in the reconstructed breast. Fourteen patients were included and examined 3-6 years after reconstruction. The untreated contralateral breast served as control. None of the patients had received any locoregional radiotherapy. The perception thresholds to touch, cold, warmth, and heat pain were assessed and a questionnaire about the patients' subjective experience of sensibility was completed. In the quantitative somatosensory testing, statistically significant impairment concerning all the examined modalities was demonstrated. The least affected was the heat pain modality. In the questionnaire, the patients reported weaker nonmodality specific sensibility from the reconstructed breast compared with the control breast. More than half of the patients reported that the reconstructed breast felt like a real breast. In conclusion, the study revealed long-term, overall sensibility impairment following nonautologous, immediate breast reconstruction.

Technical aspects of immediate breast reconstruction with implants: five year follow-up.

We describe the technical aspects of 249 patients who had immediate breast reconstruction with implants and a follow-up of at least five years. The type of reconstruction was permanent expander prostheses (n=208), permanent prostheses (n=32), and temporary expander prostheses (n=9). The median total number of operations required to complete the reconstruction was 3 (range 1-6) with nipple-reconstruction included. Thirty-two patients developed local complications (13%) and three had systemic complications (1%). Eighteen implants were lost, so the failure rate of reconstruction was 7%. The technique of immediate breast reconstruction with implants is associated with a low overall morbidity. This, combined with earlier reported psychological advantages, no increased risk of cancer relapse, and reasonable cost, indicates the importance of immediate reconstruction with implants in the treatment of breast cancer.

Quality of life and patient satisfaction in breast cancer patients after immediate breast reconstruction: a prospective study.

The aim of immediate breast reconstruction is to improve well-being and quality of life for women undergoing mastectomy for breast cancer. This prospective study used the SF-36 Health Survey questionnaire to assess quality of life before and 12 months after mastectomy and immediate breast reconstruction together with patients' expectations of and satisfaction with the immediate breast reconstruction with implant. Scores for 76 participants were compared with those in 920 age-matched women from the general population. Preoperative scores for emotional well-being and physical role functioning were lower than in the reference population, while after 12 months the scores in all domains had improved and were comparable with those in the reference population. The most common reason for immediate reconstruction was the desire to avoid an external prosthesis. Most women were satisfied with immediate reconstruction, and the major determinant of aesthetic satisfaction was completion of the procedure. Although many factors may influence quality of life, 1 year after breast cancer surgery with immediate reconstruction scores are equivalent to those of the normal population.