TUmor-volume to breast-volume RAtio for improving COSmetic results in breast cancer patients (TURACOS); a randomized controlled trial.

BACKGROUND: Cosmetic result following breast conserving surgery (BCS) for cancer influences quality of life and psychosocial functioning in breast cancer patients. A preoperative prediction of expected cosmetic result following BCS is not (yet) standard clinical practice and therefore the choice for either mastectomy or BCS is still subjective. Recently, we showed that tumour volume to breast volume ratio as well as tumour location in the breast are independent predictors of superior cosmetic result following BCS. Implementation of a prediction model including both factors, has not been studied in a prospective manner. This study aims to improve cosmetic outcome by implementation of a prediction model in the treatment decision making for breast cancer patients opting for BCS. METHODS/DESIGN: Multicentre, single-blinded, randomized controlled trial comparing standard preoperative work-up to a preoperative work-up with addition of the prediction model. Tumour volume to breast volume ratio and tumour location in the breast will be used to predict cosmetic outcome in invasive breast cancer patients opting for BCS. Three dimensional (3D)-ultrasonography will be used to measure the tumour volume to breast volume ratio needed for the prediction model. Sample size was estimated based on a 14% improvement in incidence of superior cosmetic result one year after BCS (71% in the control group versus 85% in the intervention group). Primarily cosmetic outcome will be evaluated by a 6-member independent panel. Secondary endpoints include; (1) patient reported outcome measured by BREAST-Q, EORTC-QLQ-C30/BR23 and EQ-5D-5 L (2) cosmetic outcome as assessed through the BCCT.core software, (3) radiation-induced reaction (4) surgical treatment performed, (5) pathological result and (6) cost-effectiveness. Follow-up data will be collected for 3 years after surgery or finishing radiotherapy. DISCUSSION: This randomized controlled trial examines the value of a preoperative prediction model for the treatment-decision making. It aims for a superior cosmetic result in breast cancer patients opting for BCS. We expect improvement of patients' quality of life and psychosocial functioning in a cost-effective way. TRIAL REGISTRATION: Prospectively registered, February 17th 2015, at 'Nederlands Trialregister - NTR4997 '.

A prospective validation study of sentinel lymph node biopsy in multicentric breast cancer: SMMaC trial.

BACKGROUND: Multicentric breast cancer is often considered a contra-indication for sentinel lymph node (SLN) biopsy due to concerns with sensitivity and false negative rate. To assess SLN feasibility and accuracy in multicentric breast cancer, the multi-institutional SMMaC trial was conducted. METHODS: In this study 30 patients with multicentric breast cancer and a clinically negative axilla were prospectively included. Periareolar injection of radioisotope and blue dye was administered. In all patients SLN biopsy was validated by back-up completion axillary lymph node dissection. RESULTS: the SLN was successfully identified in 30 of 30 patients (identification rate 100%). The incidence of axillary metastases was 66.7% (20/30). The false negative rate was 0% (0/20) and the sensitivity was 100% (20/20). The negative predictive value was 100% (10/10). CONCLUSION: SLN biopsy in multicentric breast cancer seems feasible and accurate and should therefore be considered in patients with multicentric breast cancer and clinically negative axilla.

The influence of mechanical bowel preparation in elective colorectal surgery for diverticulitis.

BACKGROUND: Mechanical bowel preparation (MBP) has been shown to have no influence on the incidence of anastomotic leakage in overall colorectal surgery. The role of MBP in elective surgery in combination with an inflammatory component such as diverticulitis is yet unclear. This study evaluates the effects of MBP on anastomotic leakage and other septic complications in 190 patients who underwent elective surgery for colonic diverticulitis. METHODS: A subgroup analysis was performed in a prior multicenter (13 hospitals) randomized trial comparing clinical outcome of MBP versus no MBP in elective colorectal surgery. Primary endpoint was the occurrence of anastomotic leakage in patients operated on for diverticulitis, and secondary endpoints were septic complications and mortality. RESULTS: Out of a total of 1,354 patients, 190 underwent elective colorectal surgery (resection with primary anastomosis) for (recurrent or stenotic) diverticulitis. One hundred and three patients underwent MBP prior to surgery and 87 did not. Anastomotic leakage occurred in 7.8 % of patients treated with MBP and in 5.7 % of patients not treated with MBP (p = 0.79). There were no significant differences between the groups in septic complications and mortality. CONCLUSION: Mechanical bowel preparation has no influence on the incidence of anastomotic leakage, or other septic complications, and may be safely omitted in case of elective colorectal surgery for diverticulitis.

Clinical experience of prophylactic mastectomy followed by immediate breast reconstruction in women at hereditary risk of breast cancer (HB(O)C) or a proven BRCA1 and BRCA2 germ-line mutation.

AIM: Women with a proven BRCA1 or BRCA2 germ-line mutation or with a 50% risk of carrying the mutation, have an increased risk of breast cancer. Regular surveillance, chemoprevention or prophylactic mastectomy (PM) are options to detect breast cancer at an early stage or to reduce the risk. We describe the management of women who have opted for PM, the postoperative complications of PM, especially in combination with immediate breast reconstruction (IBR), and the oncological follow-up. METHODS: The medical records of all women who underwent a PM from December 1993 to December 1999 have been reviewed with respect to management, patient characteristics, complications and oncological follow-up. RESULTS: During the study period 112 women with a median age of 38.8 years opted for a PM: 76 were germline mutation carriers. After PM, 79 women without breast or ovarian cancer in their medical history, were free of disease after 2.5 years (median). Before PM, 29 women had been treated for breast cancer, 3.9 years (median) previously; 5 of these women had developed metastatic disease by the last consultation. Before PM, 2 patients had been treated for DCIS and 2 patients for ovarian cancer. Four DCIS were found; none of these women had evidence of disease 4.0 years (median) after PM. In 59 women laparoscopic prophylactic bilateral oophorectomy (PBO) was performed; 36 simultaneously with PM and 23 separately. A total of 103 women (92%) opted for IBR. After PM, the complication rate for IBR was 21%: 11% within 6 weeks and 10% at long-term follow-up (median 3.5) after PM, including the removal of 10 prostheses. CONCLUSIONS: Women with an increased risk of breast cancer due to a genetic predisposition should be adequately informed about the different treatment options in the setting of a multidisciplinary approach. PM can simultaneously be combined with PBO and IBR. IBR can facilitate the decision to undergo a PM. PM followed by IBR has an acceptable complication rate.

A prospective study on silicone breast implants and the silicone-related symptom complex.

This cohort study prospectively evaluated the prevalence of the silicone-related symptom complex (SRSC) in relation to antinuclear antibodies (ANA) and magnetic resonance imaging (MRI) of silicone breast implants (SBI) 1 year after implantation. A total of 57 women undergoing mastectomy followed by immediate breast reconstruction (IBR) and SBI between March 1995 and March 1997 at the University Hospital Rotterdam/Daniel den Hoed Cancer Centre, were prospectively evaluated. Just before and 1 year after IBR the sera of these women were tested for the presence of ANA and they were screened for the prevalence of SRSC-related symptoms by questionnaire. All prostheses were evaluated by MRI 1 month and 1 year after IBR. Just before operation 11% of the women had a Sjögren score of more than 2, whereas 30% had such a score 1 year after IBR ( P = 0.01). One year postoperatively women had significantly more RA/Raynaud-related complaints: 21% preoperatively versus 40% 1 year after IBR ( P = 0.03). Within the undefined complaints-related group 19% had a score of 2 or more preoperatively and 33% 1 year after IBR ( P = 0.09). There were no new cases of ANA positivity 1 year after IBR. The linguine sign was seen by MRI in three implants: one 1 month after IBR and two 1 year after IBR. There was no relation to changes in SRSC expression and these MRI findings. In conclusion, 1 year after SBI implantation women had more SRSC-related complaints, especially Sjögren's and RA/Raynaud's. Moreover there was no correlation between elevated SRSC expression and changes in the presence of ANA or changes in MRI of the SBI 1 year after IBR.

Motivations, satisfaction, and information of immediate breast reconstruction following mastectomy.

This study evaluated patients' motivations for, and satisfaction with, the treatment and information of immediate breast reconstruction (IBR) with a silicone prosthesis. It studied satisfaction more deeply by relating it to the quality of life, body-image and sexual functioning. Seventy-three patients who received mastectomy, followed by IBR with a subpectoral silicone prosthesis, completed a self-report questionnaire concerning their motivations for, perceived advantages of and satisfaction with IBR, the information received, quality of life, body image, and sexual functioning. Despite the fact that 50% of the reconstructions resulted in complications or complaints, 70% of the women were satisfied with the reconstruction and only 12% would never choose IBR again. Satisfaction was strongly correlated with the need for information. The higher the patient's expectations, the higher their need for information. The most common perceived advantage of IBR was the avoidance of an external prosthesis. A majority of patients were satisfied with the breast reconstruction. However, a sizeable proportion needed more information about breast reconstruction and the use of the silicone prosthesis. To avoid too high expectations more attention should be given to possible complications and the moderate cosmetic results.

Morbidity of immediate breast reconstruction (IBR) after mastectomy by a subpectorally placed silicone prosthesis: the adverse effect of radiotherapy.

AIMS: This study evaluates the incidence of local complications after immediate breast reconstruction (IBR) following mastectomy with a subpectorally placed silicone prosthesis, with emphasis on the effect of radiation treatment on IBR. METHODS: The medical records of 100 women, who underwent a mastectomy followed by IBR with a subpectorally placed silicone prosthesis at the University Hospital Rotterdam/Daniel den Hoed Cancer Center, between March 1990 and March 1995, were reviewed. Thirteen prostheses were implanted prior to radiation treatment, and 15 prostheses were implanted after irradiation of the chest wall. RESULTS: Early complications were seen in 15% of the IBR and were more often in irradiated women. At long-term follow-up, the most common complication was capsular contracture (21%). This occurred significantly more around prostheses placed in a previously irradiated area (P<0.0005), or which were irradiated after IBR (P=0.001). Loss of prosthesis was seen in 11 cases, and was significantly (P<0.005) more in irradiated women (n=5; 18%) compared to women who were not irradiated (n=6; 7%). CONCLUSIONS: Complications after IBR with a silicone prosthesis were more common in women who were treated with radiotherapy prior to or after IBR following mastectomy than in women who were not irradiated. In particular, capsular contracture around a prosthesis placed in a previously irradiated area was significantly increased. The use of musculocutaneous flaps, such as the transverse rectus abdominis muscle or latissimus dorsi flap, is preferable for reconstruction of previously irradiated breasts. There is no indication to remove the prosthesis before radiation therapy of the chest wall.

First evaluation study of the Dutch Working Party on silicone breast implants (SBI) and the silicone-related symptom complex (SRSC).

This cohort study evaluates the postoperative prevalence of antinuclear antibodies (ANA) in relation to symptoms related to the so-called silicone-related symptom complex (SRSC). A total of 63 women who underwent mastectomy followed by immediate breast reconstruction with a silicone implant (SBI) between Septembber 1990 and May 1995 at the University Hospital Rotterdam/Daniel den Hoed Cancer Center, participated voluntarily in the study. Their sera were tested for the presence of antinuclear antibodies (ANA) and at the same time they were screened for the prevalence of SRSC-related symptoms by questionnaire. All patients were also examined physically. Sixteen per cent of the women were ANA positive. There was no difference in SRSC expression between ANA-positive and ANA-negative women. The lack of difference in symptom expression between the ANA-positive and ANA-negative women and the rather low complaint percentage proves that if ANA positivity is related to the SRSC, we found no evidence that patients with a SBI with a positive ANA differed from the ANA-negative patients.

Prognostic value of the TNM-classification for small bowel cancer.

BACKGROUND/AIMS: To examine the relationship between the pathological stage and survival for adenocarcinoma of the small bowel. MATERIALS AND METHODS: The medical records of 99 patients with small bowel cancer, diagnosed between January 1984 and December 1993, were reviewed retrospectively. Lymphomas and carcinomas of the ampulla of Vater were excluded from this study. All operated patients with adenocarcinomas were staged by the TNM-classification using pathological and surgical reports. RESULTS: Sixty-four adenocarcinomas, 24 carcinoid tumours and 11 sarcomas were analysed. The cancer-specific 5-year survival rate for patients with adenocarcinoma, carcinoid tumours and sarcomas was 22%, 39% and 55%, respectively. Twenty-eight patients with adenocarcinoma underwent radical tumor resection: segmental resection in 20, pancreaticoduodenectomy in 7 and ileocoecal resection in one patient. In the remaining 34 patients "curative" resection was not feasible and none of them survived for more than 3 years. The 5-year survival rate of the curatively resected patients was 46%. Actuarial 3-year survival rate for stage I was 38%, 70% for stage II and 0% for stage III. CONCLUSION: Our results demonstrate that survival is poor for patients with lymph node metastasis, despite apparently curative surgery.

Repair of aortic arch interruption by direct anastomosis.

OBJECTIVE: Evaluation of surgical treatment of interrupted aortic arch (IAA) by direct anastomosis. METHODS: A consecutive series of 17 infants with IAA (type A in eight patients, type B in nine) were operated upon. The mean age at arch repair was 1.0 month (range 0.2-7.7), mean weight was 3.7 kg (range 2.2-6.2). All arch repairs were done by direct anastomosis. This included a persistent arterial duct in one and a subclavian turnup in another case. The aortic reconstruction included reimplantation of a lusoric artery in three patients, patch enlargement of the ascending aorta in three and of the complete arch in one patient. The arch repair was done through a lateral thoracotomy in three patients. In 14 patients the aortic repair was part of a single-stage approach through a median sternotomy using cardiopulmonary bypass and circulatory arrest. RESULTS: There was no operative mortality. One patient (single-stage approach) died 2 days after operation due to respiratory problems caused by tracheobronchomalacy. One patient (lateral approach) died suddenly 3 months after aortic repair and banding. Median follow up was 4.8 years (range 0.1-12.9). In five patients restenosis of the aortic arch developed, all within 1.5 years after repair. This was not correlated with the type of interruption, weight at operation, age at operation or the surgical approach. The actuarial freedom from restenosis was 61% at 5 years with a 70% confidence limit (CL70%) of 46-75. All restenoses were balloon dilated, but two needed redo surgery, which was done by the median approach. In three patients discrete subaortic stenosis developed. This was not correlated with the type of interruption, weight at operation, age at operation or the surgical approach. The actuarial freedom from subaortic stenosis was 68% at 5 years (CL70% = 54-83). These stenoses were treated by enucleation, followed in one patient by a pulmonary autograft procedure for recurrent root stenosis after another year. At the end of follow up all patients were thriving well, lacked symptoms, were normotensive and had normal femoral artery pulsations. CONCLUSIONS: IAA can be treated well with primary anastomosis. Possible restenosis of the aortic arch can adequately be treated by percutaneous balloon dilatation or redo surgery if necessary. Arch repair by median single-stage approach has our preference.

The pedicled omentoplasty and split skin graft (POSSG) for reconstruction of large chest wall defects. A validity study of 34 patients.

The aim of this study was to evaluate retrospectively the results of pedicled omentoplasty and split skin graft (POSSG) in reconstructing (full thickness) chest wall defects, and to define its role as a palliative procedure for local symptom control. Thirty-four patients with recurrent breast cancer (n = 25), radiation-induced necrosis (n = 5) or sarcoma (n = 4) of the chest wall were selected for the study. All patients underwent curative or palliative chest wall resection with reconstruction by pedicled omentoplasty and split skin graft (POSSG), between 1986 and 1994. Reconstructive outcome, complications, local tumour and symptom control following surgery was measured. The most common complication was shown to be partial necrosis of the omental flap (35%), followed by respiratory problems (26%), facial hernia (26%) and thoracic wound problems (15%), which were mostly treated in a conservative way (68%). The 3-year local tumour-free interval after POSSG in patients curatively treated for breast cancer is 16%. Seventy per cent of the patients who underwent palliative resection had longstanding relief of local pain, bleeding or foetor due to local tumour growth. It can be concluded that large (full thickness) chest wall defects after resection of local recurrence, primary malignancy or osteoradionecrosis of the chest wall can successfully be reconstructed by POSSG. Chest wall resection in patients treated with palliative intention is effective in local symptom control.