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.

Patient-reported cosmetic satisfaction and the long-term association with quality of life in irradiated breast cancer patients.

PURPOSE: To evaluate patient-reported cosmetic satisfaction in women treated with radiation therapy for breast cancer and to determine the association between dissatisfaction and quality of life (QoL) and depression. METHODS: Within the prospective UMBRELLA breast cancer cohort, all patients ≥ 1 year after breast conserving treatment or mastectomy with immediate reconstruction were selected. Self-reported cosmetic satisfaction was measured on a 5-point Likert scale. QoL, social functioning, and emotional functioning were measured using EORTC QLQ-C30 and BR23 at 1, 2, and 3 years after inclusion. Mixed model analysis was performed to assess the difference in different domains of QoL between patients with good versus poor self-reported cosmetic satisfaction over time after adjustment for potential confounders. Depression scores were collected by means of the HADS-NL questionnaire. Chi-square test or Fisher's exact test was used to assess the difference in proportions of HADS score ≥ 8, indicating increased depression risk, between satisfied and dissatisfied patients. RESULTS: 808 patients were selected for analysis. Respectively one, two, and three years after surgery, 8% (63/808), 7% (45/626), and 8% (31/409) of patients were dissatisfied with their cosmetic outcome. Poor patient-reported cosmetic satisfaction was independently associated with impaired QoL, body image, and lower emotional and social functioning. Scores ≥ 8 on the HADS depression subscale were significantly more common in dissatisfied patients. CONCLUSIONS: Dissatisfaction with cosmetic outcome was low after breast cancer surgery followed by radiation therapy during 3 years follow-up. Knowing the association between dissatisfaction with cosmetic outcome and QoL and depression could help to improve the preoperative counseling of breast cancer patients.

Short-term follow-up after laparoscopic versus conventional total mesorectal excision for low rectal cancer in a large teaching hospital.

PURPOSE: Laparoscopic resection for low rectal cancer remains controversial, and large randomized studies on oncologic outcome are lacking. The objective of this study was to analyze the short-term results of laparoscopic resection versus conventional total mesorectal excision (TME) for low rectal cancer (≤10 cm from the anal verge). METHODS: The institutional colorectal surgery database was reviewed, and 166 consecutive patients operated for low rectal cancer between 2006 and 2011 were included in this analysis which focuses on the first 18 months of follow-up. RESULTS: Eighty patients underwent conventional TME, whereas 86 patients underwent laparoscopic TME. Patient characteristics were comparable between groups. Conversion rate was 17 %. Laparoscopic rectal resection resulted in significantly less blood loss (200 versus 475 ml, p = <0.001) and a 3-day shorter hospital stay (median, 7 versus 10 days; p = 0.06). Oncologic results from resected specimens were comparable, although significantly more lymph nodes were harvested in laparoscopic resections (median, 13 versus 11; p = 0.005). Disease-free survival after curative resection was better in the laparoscopic group (p = 0.04), but this was no longer significant after correction for potential confounders. CONCLUSIONS: This analysis of short-term results of laparoscopic versus conventional TME for low rectal cancer demonstrates that laparoscopic surgery is feasible and safe, resulting in similar oncologic outcomes with less blood loss, a trend towards less postoperative complications and shorter duration of hospital stay. Further randomized studies are needed to attribute to the body of evidence of equivalence or even superiority of laparoscopic resections compared to conventional resections for distal rectal cancer.

Patient-Reported Symptoms of Late Toxicity in Patients With Breast Cancer Treated With Hypofractionated Radiation Therapy and the Association With Quality of Life.

PURPOSE: Our purpose was to assess the prevalence of patient-reported symptoms of local late toxicity in patients with irradiated breast cancer and determine the association between late toxicity and quality of life. METHODS: Within the prospective Utrecht cohort for Multiple BReast cancer intErvention studies and Long-term evaluation cohort, a survey on self-reported late toxicity was sent to all patients with breast cancer with ≥12 months interval since radiation therapy treated with curative intent. Patients were treated with hypofractionated radiation therapy of 40 Gy/15 fractions or 42.5 Gy/16 fractions, with or without a simultaneous integrated boost. Symptoms of late toxicity were evaluated on a 4-point Likert scale. Late toxicity was defined as moderate-severe breast or chest wall pain combined with at least 1 other mild-severe late toxicity symptom, that is, breast or arm/hand lymphedema, firmness of the breast, or impaired arm movement. Physical, role, and social functioning were measured before, during, and after the late toxicity survey using the European Organization for Research and Treatment of Cancer Quality of Life Core questionnaire-C30 and compared with a Dutch normative population. RESULTS: In the study, 1613/2248 patients (72%) were included. Of those, 16% (n = 265) reported late toxicity. The median time interval between radiation therapy and survey was 38 months (interquartile range, 21-55). Moderate/severe firmness of the breast, chest wall pain, and breast pain were reported by, respectively, 18% (n = 295), 14% (n = 225), and 10% (n = 140) of all patients. Physical, role, and social functioning were below the clinical threshold (ie, clinically relevant impairment) in 13% to 52% of patients with late toxicity and 2% to 26% of patients without late toxicity. Patients with late toxicity significantly more often received analgesics, physiotherapy, and lymphedema therapy compared with patients without late toxicity. CONCLUSIONS: This study provided insight into the prevalence of patient-reported late toxicity after hypofractionated radiation therapy and the influence of late toxicity on quality of life after breast cancer. These results may help health care professionals to inform their patients about long-term effects of breast cancer treatment including hypofractionated radiation therapy.

J-pouch vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision for rectal cancer: a multicentre randomized trial.

AIM: Comparison of functional and surgical outcome of the J-pouch with the side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision in rectal cancer patients. METHOD: In a multicentre study, patients with a carcinoma of the lower two-thirds of the rectum were randomized to either a J-pouch or a side-to-end reconstruction. Primary outcome was function of the neorectum 1 year after surgery. A functional outcome [COloREctal Functional Outcome (COREFO)] questionnaire, and two quality of life questionnaires (EORTC-QLQ-CR38 and SF-36) were to be completed by all participants preoperatively, and 4 and 12 months postoperatively. Independent data managers recorded surgical outcome. A group size of 30 patients in each group was calculated based on a 15-point difference of the COREFO scale. RESULTS: In total, 107 patients were randomized, 55 in the J-pouch group and 52 in the side-to-end anastomosis group. The COREFO incontinence scale at 4 months and the total functional outcome at 4 and 12 months showed better results for the J-pouch group in comparison with the side-to-end anastomosis group. The remaining COREFO scales (frequency, social impact, stool-related aspects and bowel medication), surgical outcome (complications, reoperations, length of hospital stay, readmissions and mortality) and quality of life did not show significant differences between treatment groups. CONCLUSION: The overall results of a coloanal J-pouch and a side-to-end anastomosis are comparable, although functional results are slightly better with a J-pouch. The side-to-end anastomosis is technically less demanding and therefore a justified alternative in sphincter-saving surgery.

Hand-assisted laparoscopic versus open approach in colorectal surgery: a systematic review.

AIM: This systematic review was performed to answer the question whether hand-assisted laparoscopic surgery (HALS) can preserve the advantages of laparoscopic compared with open surgery in colorectal disease. METHOD: Eligible studies were identified from electronic databases (Medline, Embase Cochrane) and cross-reference search. The database search, quality assessment and data extraction were independently performed by two reviewers. Outcome criteria were operative time, number of trocars used, conversion rate, incision length, blood loss, time to passage of flatus, use of analgesia, postoperative morbidity, in-hospital mortality, length of hospital stay, number of lymph nodes and costs. RESULTS: Out of 162 publications seven publications were selected for comprehensive review. Three randomized controlled trials (RCT) and four non-RCTs, comprising 571 patients, met the inclusion criteria. Because of heterogeneity, the data could not be pooled. The operative time was significantly longer in HALS in four of the seven studies (addition in median operative time of 13-81 min). The conversion rate varied from 0 to 10%. Two of the four reporting studies demonstrated a significantly shorter time to passage of flatus in HALS (averagely one day in advance). Length of hospital stay was significantly shorter in HALS in four of the seven studies (average gain between 2 and 4 days). CONCLUSIONS: Hand-assisted laparoscopic surgery has the advantages of laparoscopic surgery over open surgery while reducing some of the disadvantages of laparoscopic surgery (shorter operative time, lower conversion rates). Especially for indications in which an incision to extract the resection specimen is required, HALS provides an excellent treatment option.

Assessing the effect of hyperbaric oxygen therapy in breast cancer patients with late radiation toxicity (HONEY trial): a trial protocol using a trial within a cohort design.

BACKGROUND: Breast cancer treatment with radiotherapy can induce late radiation toxicity, characterized by pain, fibrosis, edema, impaired arm mobility, and poor cosmetic outcome. Hyperbaric oxygen therapy (HBOT) has been proposed as treatment for late radiation toxicity; however, high-level evidence of effectiveness is lacking. As HBOT is standard treatment and reimbursed by insurers, performing classic randomized controlled trials is difficult. The "Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity" (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design. METHODS: The HONEY trial will be conducted within the Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaluation (UMBRELLA). Within UMBRELLA, breast cancer patients referred for radiotherapy to the University Medical Centre Utrecht are eligible for inclusion. Patients consent to collection of clinical data and patient-reported outcomes and provide broad consent for randomization into future intervention studies. Patients who meet the HONEY in- and exclusion criteria (participation ≥ 12 months in UMBRELLA, moderate/severe breast or chest wall pain, completed primary breast cancer treatment except hormonal treatment, no prior treatment with HBOT, no contraindications for HBOT, no clinical signs of metastatic or recurrent disease) will be randomized to HBOT or control group on a 2:1 ratio (n = 120). Patients in the control group will not be informed about participation in the trial. Patients in the intervention arm will undergo 30-40 HBOT treatment sessions in a high pressure chamber (2.4 atmospheres absolute) where they inhale 100% oxygen through a mask. Cohort outcome measures (i.e., physical outcomes, quality of life, fatigue, and cosmetic satisfaction) of the HBOT group will be compared to the control group at 3 months follow-up. DISCUSSION: This pragmatic trial within the UMBELLA cohort was designed to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the TwiCs design. Use of the TwiCs design is expected to address issues encountered in classic randomized controlled trials, such as contamination (i.e., HBOT in the control group) and disappointment bias, and generate information about acceptability of HBOT. TRIAL REGISTRATION: ClinicalTrials.gov. NCT04193722 . Registered on 10 December 2019.

Factors determining delay in relaparotomy for anastomotic leakage after colorectal resection.

AIM: To analyze the time interval ('delay') between the first occurrence of clinical parameters associated with anastomotic leakage after colorectal resection and subsequent relaparotomy. METHODS: In 36 out of 289 consecutive patients with colorectal anastomosis, leakage was confirmed at relaparotomy. The medical records of these patients were retrospectively analysed and type and time of appearance of clinical parameters suggestive of anastomotic leakage were recorded. These parameters included heart rate, body temperature, local or generalized peritoneal reaction, leucocytosis, ileus and delayed gastric emptying. Factors influencing delay of relaparotomy and consequences of delayed recognition and treatment were determined. RESULTS: First documentation of at least one of the predefined parameters for anastomotic leakage was after a median interval of 4 +/- 1.7 d after the operation. The median number of days between first parameter(s) associated with leakage and relaparotomy was 3.5 +/- 5.7 d. The time interval between the first signs of leakage and relaparotomy was significantly longer when a weekend was included (4.2 d vs 2.4 d, P = 0.021) or radiological evaluation proved to be false-negative (8.1 d vs 3.5 d, P = 0.007). No significant association between delay and number of additional relaparotomies, hospital stay or mortality could be demonstrated. CONCLUSION: An intervening weekend and negative diagnostic imaging reports may contribute to a delay in diagnosis and relaparotomy for anastomotic leakage. That delay was more than two days in two-thirds of the patients.

Radiological evaluation of colorectal anastomoses.

BACKGROUND AND AIMS: The purpose of this study was to determine the accuracy, interobserver variability, timing and discordance with relaparotomy of postoperative radiological examination of colorectal anastomoses. PATIENT/METHODS: From 2000 to 2005, 429 patients underwent an ileocolonic, colo-colonic, or colorectal anastomosis. Radiological examination of the anastomosis was not performed routinely, but only when there were clinically signs of leakage. Radiological imaging was reviewed by an independent radiologist and medical records were retrospectively analyzed. Clinical anastomotic leakage was the standard of reference and defined as leakage confirmed during relaparotomy, drainage of pus per anum or as an anastomotic defect identified at digital examination. RESULTS: Radiological evaluation of the anastomosis was performed in 91 patients (21%): CT in 27 patients, contrast radiography in 40, and both imaging modalities in 24 patients. The interobserver variability of CT and contrast radiography was 10% and 14%, respectively. The sensitivity and negative predictive value of imaging of the anastomosis was 65% and 73%, respectively. Anastomotic leakage was found in 11 of 21 patients (52%) who underwent relaparotomy despite negative imaging. Three of 36 patients (8%) with a diagnosis of anastomotic leakage based on radiological examination had an intact anastomosis at relaparotomy. CONCLUSION: Radiological imaging of the anastomosis after colorectal surgery should be restrictively applied and interpreted with caution because of the high false-negative rate and the substantial interobserver variability.

Outcome of rectal cancer surgery after the introduction of preoperative radiotherapy in a low-volume hospital.

BACKGROUND: The improvement in local control by preoperative radiotherapy for rectal cancer can be at the cost of substantial morbidity. AIM OF THE STUDY: The aim of this study was to determine the impact of short-course preoperative radiotherapy on morbidity and mortality after total mesorectal excision in a low-volume hospital. METHODS: From 2000 to 2007, 104 patients underwent rectal resection for a proven malignancy. Outcome parameters including anastomotic leakage rate, duration of hospital stay, and survival were retrospectively compared between patients who received radiotherapy followed by resection and patients who underwent resection alone. RESULTS: Anastomotic leakage occurred in 11 of 28 patients (39%) who underwent radiotherapy and in 10 of 54 patients (19%) in the surgery-alone group (P = 0.04). The length of hospital stay was significantly longer in the radiotherapy group in comparison with the surgery-alone group (median 22 vs. 12 days; P = 0.002). Independent predictors of decreased overall survival were high American Society of Anesthesiologists classification, application of preoperative radiotherapy, necessity of Intensive Care Unit admission, and advanced pathological stage. CONCLUSIONS: A negative impact of preoperative radiotherapy on morbidity and mortality after rectal cancer surgery with an annual caseload of 16 was observed. Auditing of local practices is essential for quality control and potential improvement of clinical outcome.