The QUILT study: quilting sutures in patients undergoing breast cancer surgery: a stepped wedge cluster randomized trial study.

BACKGROUND: Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting suture technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. However, implementation is lagging due to unknown side effects, increase in operation time and cost effectiveness. Main objective of this study is to assess the impact of large scale implementation of the quilting suture technique in patients undergoing mastectomy and/or axillary lymph node dissection (ALND). METHODS: The QUILT study is a stepped wedge design study performed among nine teaching hospitals in the Netherlands. The study consists of nine steps, with each step one hospital will implement the quilting suture technique. Allocation of the order of implementation will be randomization-based. Primary outcome is 'textbook outcome', i.e.no wound complications, no re-admission, re-operation or unscheduled visit to the outpatient clinic and no increased use of postoperative analgesics. A total of 113 patients is required based on a sample size calculation. Secondary outcomes are shoulder function, cosmetic outcome, satisfaction with thoracic wall and health care consumption. Follow-up lasts for 6 months. DISCUSSION: This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. We hypothesize that quilting is a simple technique to increase textbook outcome, enhance patient comfort and reduce health care consumption.

Sentinel lymph node biopsy can be omitted in DCIS patients treated with breast conserving therapy.

Breast cancer guidelines advise sentinel lymph node biopsy (SLNB) in patients with ductal carcinoma in situ (DCIS) on core biopsy at high risk of invasive cancer or in case of mastectomy. This study investigates the incidence of SLNB and SLN metastases and the relevance of indications in guidelines and literature to perform SLNB in order to validate whether SLNB is justified in patients with DCIS on core biopsy in current era. Clinically node negative patients diagnosed from 2004 to 2013 with only DCIS on core needle biopsy were selected from a national database. Incidence of SLN biopsy and metastases was calculated. With Fisher exact tests correlation between SLNB indications and actual presence of SLN metastases was studied. Further, underestimation rate for invasive cancer and correlation with SLN metastases was analysed. 910 patients were included. SLNB was performed in 471 patients (51.8 %): 94.5 % had pN0, 3.0 % pN1mi and 2.5 % pN1. Patients undergoing mastectomy had 7 % SLN metastases versus 3.5 % for breast conserving surgery (BCS) (p = 0.107). The only factors correlating to SLN metastases were smaller core needle size (p = 0.01) and invasive cancer (p < 0.001). Invasive cancer was detected in 16.7 % by histopathology with 15.6 % SLN metastases versus only 2 % in pure DCIS. SLNB showed metastases in 5.5 % of patients; 3.5 % in case of BCS (any histopathology) and 2 % when pure DCIS was found at definitive histopathology (BCS and mastectomy). Consequently, SLNB should no longer be performed in patients diagnosed with DCIS on core biopsy undergoing BCS. If definitive histopathology shows invasive cancer, SLNB can still be considered after initial surgery.

Repeat sentinel node biopsy should be considered in patients with locally recurrent breast cancer.

Most patients with locally recurrent breast cancer undergo axillary lymph node dissection (ALND). However, repeat sentinel node biopsy (SNB) could provide regional nodal staging and obviate the need for standard ALND. The Sentinel Node and Recurrent Breast Cancer (SNARB) study is a Dutch nationwide registration study conducted to determine feasibility, aberrant drainage rates, and clinical consequences of repeat SNB. A total of 536 patients with locally recurrent non-metastatic breast cancer underwent lymphatic mapping and repeat SNB in 29 Dutch hospitals. A repeat sentinel node (SN) was identified in 333 of 536 patients (62.1 %) and surgically harvested in 287 patients (53.5 %). Aberrant lymph drainage was observed in 180 (54.1 %) of the 333 patients, more often after previous ALND (81.9 %) than SNB (28.4 %; P < 0.001). In 230 patients (80.1 %), the retrieved SN was tumor negative; 17 SNs (5.9 %) contained a micrometastasis and 29 (10.1 %) a macrometastasis. Confirmation ALND in 31 repeat SN-negative patients revealed a macrometastasis in two patients (6.5 %). The negative predictive value (NPV) of repeat SNB was 93.6 %, and ALND was omitted in 109 of the 248 patients (44.0 %) with a negative repeat SN. In 29 of the 44 patients (63.0 %) with a positive SN, adjuvant treatment plans were altered based on the repeat SNB. Repeat SNB is a feasible procedure with a high NPV, leading to a change in management in a substantial proportion of patients. Therefore, repeat SNB should replace routine ALND and serve as the standard of care in recurrent breast cancer.

Improving the Success Rate of Repeat Sentinel Node Biopsy in Recurrent Breast Cancer.

PURPOSE: Repeat sentinel node biopsy (SNB) is an alternative to axillary lymph node dissection (ALND) for axillary staging in recurrent breast cancer. This study was conducted to determine factors associated with technical success of repeat SNB. METHODS: A total of 536 patients with locally recurrent nonmetastatic breast cancer underwent lymphatic mapping (LM) and repeat SNB in 29 Dutch hospitals. RESULTS: A total of 179 patients previously underwent breast-conserving surgery (BCS) with SNB, 262 patients BCS with ALND and 61 patients mastectomy, 35 with SNB and 26 with ALND. Another 34 patients underwent breast surgery without axillary interventions. A repeat sentinel node (SN) was identified in 333 patients (62.1 %) and was successfully removed in 235 (53.5 %). The overall repeat SN identification rate was 62.1 %, varying from 35 to 100 % in the participating hospitals. Previous radiotherapy of the breast [odds ratio (OR) 0.16; 95 % confidence interval (CI) 0.03-0.84], subareolar tracer injection (OR 0.34; 95 % CI 0.16-0.73), and a 2-day LM protocol (OR 0.57; 95 % CI 0.33-0.97) after previous BCS were independently associated with failure of SN identification. Injection of a larger amount of tracer (>180 MBq) led to a higher identification rate (OR 4.40; 95 % CI 1.45-13.32). CONCLUSIONS: Repeat SNB is a technically feasible procedure for axillary staging in recurrent breast cancer patients. Previous radiotherapy appears to be associated with failure of SN identification. Injection with a larger amount of tracer (>180 MBq) leads to a higher identification rate; subareolar injection and a 2-day LM protocol after previous BCS appear to be less adequate.

Nurse-led telephone follow-up and an educational group programme after breast cancer treatment: results of a 2 × 2 randomised controlled trial.

OBJECTIVE: To investigate whether frequent hospital follow-up in the first year after breast cancer treatment might partly be replaced by nurse-led telephone follow-up without deteriorating health-related quality of life (HRQoL), and whether a short educational group programme (EGP) would enhance HRQoL. PATIENTS AND METHODS: A multicentre pragmatic randomised controlled trial (RCT) with a 2×2 factorial design was performed among 320 breast cancer patients who were treated with curative intent. Participants were randomised to follow-up care as usual (3-monthly outpatient clinic visits), nurse-led telephone follow-up, or the former strategies combined with an educational group programme. The primary outcome for both interventions was HRQoL, measured by EORTC QLQ-C30. Secondary outcomes were role and emotional functioning and feelings of control and anxiety. RESULTS: Data of 299 patients were available for evaluation. There was no significant difference in HRQoL between nurse-led telephone and hospital follow-up at 12 months after treatment (p = 0.42; 95% confidence interval (CI) for difference: -1.93-4.64) and neither between follow-up with or without EGP (p = 0.86; 95% CI for difference: -3.59-3.00). Furthermore, no differences between the intervention groups and their corresponding control groups were found in role and emotional functioning, and feelings of control and anxiety (all p-values > 0.05). CONCLUSION: Replacement of most hospital follow-up visits in the first year after breast cancer treatment by nurse-led telephone follow-up does not impede patient outcomes. Hence, nurse-led telephone follow-up seems an appropriate way to reduce clinic visits and represents an accepted alternative strategy. An EGP does not unequivocally affect positive HRQoL outcomes.

Economic evaluation of four follow-up strategies after curative treatment for breast cancer: results of an RCT.

BACKGROUND: An economic evaluation was performed alongside a randomised controlled trial (ISRCTN 74071417) investigating the cost-effectiveness of nurse-led telephone follow-up instead of hospital visits, and of a short educational group programme (EGP) in the first year after breast cancer treatment. METHOD: This economic evaluation (n = 299) compared the one-year costs and the effects of four follow-up strategies: (1) hospital follow-up; (2) nurse-led telephone follow-up; (3) hospital follow-up plus EGP; and (4) nurse-led telephone follow-up plus EGP. Costs were measured using cost diaries and hospital registrations. Quality-adjusted life years (QALYs) were measured using the EQ-5D. Outcomes were expressed in incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves. RESULTS: Hospital follow-up plus EGP yielded most QALYs (0.776), but also incurred the highest mean annual costs (€4914). The ICER of this strategy versus the next best alternative, nurse-led telephone follow-up plus EGP (0.772 QALYs and €3971), amounted to €235.750/QALY. Hospital and telephone follow-up without EGP both incurred higher costs and less QALYs than telephone follow-up plus EGP and were judged inferior. Hospital follow-up plus EGP was not considered cost-effective, therefore, telephone follow-up plus EGP was the preferred strategy. The probability of telephone follow-up plus EGP being cost-effective ranged from 49% to 62% for different QALY threshold values. Secondary and sensitivity analyses showed that results were robust. CONCLUSION: Nurse-led telephone follow-up plus EGP seems an appropriate and cost-effective alternative to hospital follow-up for breast cancer patients during their first year after treatment.

Localization of non-palpable breast cancer using a radiolabelled titanium seed.

BACKGROUND: Resection guided by a radiologically placed hookwire is the most common surgical technique for non-palpable breast cancer. This technique has several well described disadvantages such as incidental migration, kinking or fracture of the wire, and difficult logistics between the radiology, surgical and nuclear medicine departments. Use of an iodine-125-radiolabelled (I-125) seed for localization of non-palpable breast tumours could potentially prevent these problems. METHODS: Data on use of the I-125 seed localization technique in 325 consecutive women were collected prospectively between October 2003 and June 2009. All patients with screen-detected, histologically proven malignancy were included. Patients with a preoperative core biopsy showing either ductal carcinoma in situ or unclear pathology were excluded from this study. RESULTS: The mean(s.d.) age of the women was 59.5(11.9) years. Localization was guided ultrasonographically in 275 procedures, stereotactically in 45 and by both techniques in five. The I-125 seed was removed by surgery after a mean of 4(5) days. The mean duration of operation was 62.9(21.2) min. Complete tumour removal was achieved in 310 procedures (95.4 per cent). CONCLUSION: Localization of impalpable breast cancer using a I-125 seed was safe and led to a high proportion of radical lumpectomies.

Identification of residual breast tumour localization after neo-adjuvant chemotherapy using a radioactive 125 Iodine seed.

INTRODUCTION: The use of neo-adjuvant chemotherapy has increased in the treatment of loco-regionally advanced primarily operable breast cancer. As a result of improved neo-adjuvant chemotherapy regimes the number of clinical as well as radiological responses have increased. In case of a complete response it is difficult to identify residual disease and to perform an adequate radical breast-conserving surgery. Therefore localization of the original tumour bed is mandatory. In this study we propose a novel technique with a seed containing radioactive 125 Iodine ((125)I). The (125)I has a half-time of 60 days and is therefore still recognisable with a gamma probe after admittance of several courses of neo-adjuvant chemotherapy. MATERIAL AND METHODS: In the period from July 2003 and November 2008, 47 consecutive patients had successful (125)I seed localization of a breast tumour before starting neo-adjuvant chemotherapy. RESULTS: The overall clinical response rate to neo-adjuvant chemotherapy was 100%. Complete clinical response occurred in 34 patients, partial clinical response occurred in 13 patients. Complete radiological response occurred in 18 patients, partial radiological response occurred in 29 patients. The initial surgical treatment consisted of breast-conserving surgery for all 47 patients, after a mean of 170 days (range: 70-220) after (125)I seed localization. In 19 patients pathology revealed no residual tumour, 23 patients showed a partial response. Only 3 lumpectomies were irradical. CONCLUSION: This study has shown that (125)I seed localization is a novel and highly successful technique in localizing the tumour bed in patients who receive neo-adjuvant chemotherapy for breast cancer leading to a high percentage of radical margins in case of breast-conserving surgery.

COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer.

INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. TRIAL DESIGN: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. TRIAL REGISTRATION: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).

[Fewer x-rays while maintaining quality of clinical care using clinical protocols for physical diagnosis of ankle injuries]. / Minder röntgenfoto's en toch goede klinische zorg door geprotocolleerde fysische diagnostiek bij enkelletsels.

OBJECTIVE: To determine whether it is possible to decrease the number of X-rays in acute ankle injury while keeping the health care constant, using a scoring system. DESIGN: Prospective. METHOD: Patients presenting in the emergency department of the University Hospital Utrecht (AZU), the Netherlands, over a one-year period of time with acute ankle injuries were subjected to a thorough physical examination based on a scoring system developed at Leiden University Hospital. The score was calculated and X-ray examination was indicated when this score was > or = 8 points. Radiological investigation or telephone interviews six weeks after injury achieved verification of the clinically relevant ankle fractures. Specificity and sensitivity were calculated from every possible cut-off point and drawn in a 'receiver operating characteristics' (ROC) curve. RESULTS: Of the 514 patients included 81 patients had a score of 8 or higher and 24 of them had a clinically relevant fracture. In 34 patients an ankle X-ray was made although their score was < 8 points. The positive and negative predictive values of the system were 30% (95% confidence interval (95% CI): 20-41) and 99% (95% CI: 97-100) respectively. The score yielded an area under the ROC curve of 91% (95% CI: 84-98). A cut-off point of 8 led to a reduction of X-rays by 60% (using the 'Ottawa ankle rules' the decrease in this population would have been 28%). On the other hand, 5 clinically relevant fractures were missed. CONCLUSION: Radiological examination in patients wit acute ankle complaints was reduced while health care remained almost constant. In the AZU, a decision was made for a major reduction in X-rays while accepting that some fractures would be missed.

Three-dimensional dynamic external fixation of distal radial fractures. A prospective study.

This prospective study describes the experience with a new dynamic external fixator which provides three degrees of freedom, while the centre of rotation of all these movements is located in the wrist. 44 patients with unstable fractures of the distal radius were included. During the period of dynamisation, with a median flexion of 30 degrees, extension of 18 degrees, radial deviation of 0 degree and ulnar deviation of 20 degrees the range of motion needed to perform activities of daily living was approached. In spite of early mobilisation reduction was maintained. The radiological result was excellent or good in 82% of the patients and the functional result was excellent or good in 92% of the cases. Pin track infections were noted rather frequently, possibly related to the interaction between the soft tissues and the fixator pins. Based on the experiences of the study the device needs further improvement.

Subfascial plate fixation of comminuted diaphyseal femoral fractures: a report of three cases utilizing biological osteosynthesis.

Internal fixation with preservation of tissues and vascularization, as in intramedullary fixation and bridging plate osteosynthesis, so-called biological osteosynthesis, has become increasingly popular. Our experiences, in three patients, using a technique of internal fixation of comminuted diaphyseal femoral fractures with an AO plate in subfascial position without exposure of the fracture site is presented. Though based on unorthodox mechanical principles, the safety and efficacy of bridging plates, even when applied in unusual situations, are illustrated.

[Moderate results of the treatment of femoral shaft fractures in children using intramedullary fixation]. / Matig resultaat van de behandeling van femurschachtfracturen bij kinderen door intramedullaire fixatie.

OBJECTIVE: To evaluate the results of treatment of femoral shaft fractures in children with intramedullary nailing. DESIGN: Retrospective. SETTING: Department of Surgery, University Hospital Utrecht, Department of Paediatric Surgery, Wilhelmina Children's Hospital, Utrecht. METHOD: Between 1982 and 1993, 27 femoral shaft fractures in 27 patients under the age of 16 were treated by intramedullary nailing. The charts and radiographs of these patients were reviewed and 24 patients were seen for follow-up examination (mean 7.5 years). Leg length was measured radiographically and anteversion of the affected and normal femora was determined by a standard computed tomography (CT) study. RESULTS: The average hospital stay was 34 days. There were no postoperative complications. At follow-up 10 patients had a leg length discrepancy < 1 cm and a rotational deformity < 10 degrees. Three patients had a shortening of the injured leg > 1 cm (max. 1.7 cm), in 6 patients the injured leg was more than 1 cm longer (max. 3.5 cm). The difference in rotation between fracture side and unaffected side was > 10 degrees in 9 patients. In 6 patients this was due to increased exorotation (max. 22 degrees) and in 3 patients to increased endorotation (max. 27 degrees). Iatrogenic injury of the epiphyseal line was not seen. CONCLUSION: Regarding leg length differences and rotational deformities intramedullary nailing was not superior to the known results of conservative treatment. The indication for operation should be carefully considered and during an operation there should be perfect control of reduction.

Bursae communicating with the hip joint. A report on 2 cases.

We present two patients in whom abnormal masses in the groin caused diagnostic difficulty. Synovial cysts and iliopsoas bursa enlargement may be more common than previously reported and should be considered in patients with unexplained hip pain and unusual ilioinguinal swelling.

Dynamic circle traction for severely comminuted intra-articular finger fractures.

Treatment of severely comminuted unstable intra-articular finger fractures has three goals: reconstruction of the articular surfaces, prevention of redislocation of those surfaces, and proper healing of the capsuloligamentous apparatus. Dynamic circle traction (DCT), as described by Schenck (1986), is based on these principles and is the first method of treatment combining traction with intermittent or continuous passive motion. In order to improve on this method we applied continuous, instead of intermittent, passive motion in a newly developed DCT-device (continuous dynamic circle-traction = CDCT). Its first clinical use is discussed below. Our results with DCT, in eight patients, and CDCT, in four patients, are encouraging. Full function was regained at follow-up, in both groups, in three-quarters of the metacarpophalangeal (MCP) and half of the proximal interphalangeal (PIP) joints involved. Average loss of range of motion of the other MCP and PIP joints was 3.7 degrees and 5.6 degrees respectively. Treatment with CDCT may yield better results than DCT; the small number of patients treated and the relatively short period of follow-up does not justify comparison of both methods.