A prospective, randomized double-blind study of the use of antibiotics at the time of mastectomy. A Randomized Controlled Trial on the Prevention of Seroma after Partial or Total Mastectomy and Axillary Lymph Node Dissection. Surgeon and hospital characteristics as predictors of major adverse outcomes following colon cancer surgery: understanding the volume-outcome relationship. Long-term quality of life in patients with rectal cancer: association with severe postoperative complications and presence of a stoma. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Delayed shoulder exercises in reducing seroma frequency after modified radical mastectomy: a prospective randomized study. Medical and psychosocial effects of early discharge after surgery for breast cancer: randomised trial. Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Impact of hospital case volume on the quality of laparoscopic colectomy in Japan. Prospective randomized study of surgical morbidity following primary systemic therapy for breast cancer. Effect of local gentamicin application on healing and wound infection in patients with modified radical mastectomy: a prospective randomized study. A prospective, randomized trial of perioperative prophylactic cefamandole in elective colorectal surgery for malignancy. Hospital caseload and the results achieved in patients with rectal cancer. Determinants of postoperative infection after laparoscopic cholecystectomy. Effect of fibrin glue on lymphatic drainage and on drain removal time after modified radical mastectomy: a prospective randomized study. Relation of hospital volume to colostomy rates and survival for patients with rectal cancer.
The ability of perioperative cefazolin to reduce the incidence of postoperative wound infection in patients undergoing ablative surgical treatment for carcinoma of the breast was tested in this prospective, randomized, double-blinded study. From May 1983 until December 1985, 118 women were divided into two groups at random. Group 1 consisted of 59 patients and received cefazolin and group 2 was made up of 59 patients who received a placebo. The groups were similar with respect to age, operative procedure, operative time and time to discharge after operation. Three infections occurred among those in group 1 and five among those in group 2 (p = 0.72). The time to onset of infection was delayed in the patients in group 1 versus those in group 2 (17.7 days versus 9.6 days, p = 0.04). Six of eight infections occurred in patients in whom an interval between biopsy and definitive surgical treatment was present. Prophylactic antibiotics in mammary operations did not reduce postoperative wound infections in this study. BACKGROUND: Wound seroma is one of the most frequent complications of mastectomy, but an effective strategy for its prevention has not yet been established. The purpose of this study was to determine the effectiveness of delayed shoulder exercise on the prevention of wound seroma after partial or total mastectomy with axillary dissection for the treatment of cancer. METHODS: This study prospectively randomized two exercise schemes after mastectomy with axillary lymph node dissection. The immediate exercise group (n =58) started shoulder exercise on the first postoperative day. In the delayed exercise group (n =58) the movement of the upper limb was limited to usual daily activities during the first postoperative week. RESULTS: Preoperative levels of shoulder function were regained within one month when shoulder exercise was delayed for one week after operation. Significant decrease of drainage volume and lower incidence of seroma formation were seen in the delayed exercise group. CONCLUSION: These observations suggest that seven days of unrestricted moverment and avoiding active exercise of the shoulder joint, is the optimal routine reduce seroma formation after mastectomy. Although numerous studies have demonstrated an association between surgical volume and improved outcome in cancer surgery, the specific structures and mechanisms of care that are associated with volume and lead to improved outcomes remain poorly defined. We hypothesize that there are modifiable surgeon and hospital characteristics that explain observed volume-outcome relationships.
                Retrospective cohort study.
                Surveillance, Epidemiology, and End Results cancer registry areas.
                Patients aged 66 years and older, diagnosed and surgically treated for stage I, II, or III colon cancer between 1992 and 1996 (n = 22 672).
                Thirty-day postoperative mortality and 30-day postoperative procedural interventions, including reoperation and image-guided percutaneous procedures.
                Surgeon volume, but not hospital volume, is a significant predictor of postoperative procedural intervention (adjusted odds ratio for very high-volume surgeons vs low-volume surgeons, 0.79; 95% confidence interval, 0.64-0.98). In the unadjusted analyses, high hospital volume (odds ratio, 0.67; 95% confidence interval, 0.56-0.81) and very high hospital volume (odds ratio, 0.65; 95% confidence interval, 0.54-0.79) is associated with lower postoperative mortality. Postoperative procedural intervention is not a significant mediator of the relationship between hospital volume and mortality. A single variable-the presence of sophisticated clinical services-was the most important explanatory variable underlying the relationship between hospital volume and mortality.
                Very high surgeon volume is associated with a reduction in surgical complications. However, the association between increasing hospital volume and postoperative mortality appears to derive mainly from a full spectrum of clinical services that may facilitate the prompt recognition and treatment of complications. The purpose of this study was to evaluate the impact of postoperative complications and the presence of a stoma on long-term quality of life in patients with rectal cancer.
                Consecutive patients with an adenocarcinoma of the rectum who underwent surgery at Maastricht University Medical Center or VieCuri Medical Center between 2003 and 2005 were included in this study. Data on surgical treatment and complications were collected. Severe postoperative complications were classified according to a standardized complication severity score. Quality of life was assessed by use of the European Organization for Research and Treatment of Cancer core and colorectal cancer-specific quality-of-life questionnaires.
                One hundred seventy patients received a questionnaire, and 121 (71%) responded. Of the responders, 33 (27.3%) patients suffered from severe postoperative complications. The median follow-up was 36 months. In the univariate analysis, patients with severe postoperative complications had a lower score on physical functioning (73 vs. 85, P = 0.031) and higher scores on pain (17 vs. 0, P = 0.025) and fatigue (33 vs. 22, P = 0.036). Stoma construction (n = 51) was associated with a higher global health status (83 vs. 75, P = 0.019), and these patients reported fewer gastrointestinal problems (P = 0.001).
                Severe postoperative complications seem to be associated with several lower quality-of-life subscores over the long term. In contrast, a stoma is associated with improved global health status and leads to fewer gastrointestinal complaints. In patients prone to complications, it may be sensible to avoid creating a low anastomosis and to construct a permanent stoma immediately. Despite limited evidence, closed suction drainage is often used to reduce the risk of seroma formation after breast cancer surgery. The aim of this study was to evaluate the effect of drains and fibrin sealant on the incidence of seroma formation.
                A total of 116 patients undergoing surgery for breast cancer were randomized to receive suction drainage (group 1; n = 58), or to receive no drain (n = 58). Patients allocated to receive no drain were further randomized to have fibrin sealant applied to the dissected area (group 2; n = 29), or to no intervention (group 3; n = 29). Outcome measures were incidence and volume of postoperative seroma, length of hospital stay and postoperative pain scores.
                There was no significant difference in the incidence of seroma between group 1 (15 of 58) and either group with no drains (ten of 29 in group 2; 12 of 29 in group 3). There was a significant reduction in hospital stay and postoperative pain scores in patients who did not have a drain. Following mastectomy without a drain, the use of fibrin sealant was associated with a significant reduction in the incidence and total volume of seroma (190 versus 395 ml; P = 0.012).
                Drains did not prevent seroma formation, and were associated with a longer postoperative stay and higher pain scores after surgery for breast cancer. In patients who had mastectomy the use of fibrin sealant reduced the rate of seroma formation.
                Copyright 2004 British Journal of Surgery Society Ltd. Seromas and impaired shoulder function are well-known complications after modified radical mastectomy for breast cancer. Early postoperative physiotherapy is a common treatment to avoid shoulder dysfunction. The aim of this study was to evaluate if the frequency of postoperative seromas could be reduced, without increasing shoulder dysfunction, by delayed postoperative shoulder exercises.
                In a prospective study 163 patients with breast cancer undergoing modified radical mastectomy were randomized to physiotherapy starting on postoperative day 1 or day 7. Patients were seen by the surgeons and the physiotherapists during hospital stay and in the outpatient department. Seromas and other complications were registered by the surgeons. The physiotherapists instructed the patients pre- and postoperatively and assessed shoulder function.
                There was a significantly higher incidence of postoperative seromas in the group of patients that started physiotherapy postoperative day 1 (38%) compared to the group that started physiotherapy postoperative day 7 (22%) (p < 0.05). There was no significant difference between the groups in the late outcome of shoulder function.
                The incidence of seromas after modified radical mastectomy for breast cancer is reduced by delaying shoulder exercises one week postoperatively. Earlier postoperative physiotherapy is not necessary to avoid impaired shoulder function. To assess the medical and psychosocial effects of early hospital discharge after surgery for breast cancer on complication rate, patient satisfaction, and psychosocial outcomes.
                Randomised trial comparing discharge from hospital 4 days after surgery (with drain in situ) with discharge after drain removal (mean 9 days in hospital). Psychosocial measurements performed before surgery and 1 and 4 months after.
                General hospital and cancer clinic in Rotterdam with a socioeconomically diverse population.
                125 women with operable breast cancer.
                Incidence of complications after surgery for breast cancer, patient satisfaction with treatment, and psychosocial effects of short stay or long stay in hospital.
                Patient satisfaction with the short stay in hospital was high; only 4% (2/56 at 1 month after surgery and 2/52 at 4 months after surgery) of patients indicated that they would have preferred a longer stay. There were no significant differences in duration of drainage from the axilla between the short stay and long stay groups (median 8 v 9 days respectively, P=0.45) or the incidence of wound complications (10 patients v 9 patients). The median number of seroma aspirations per patient was higher for the long stay group (1 v 3.5, P=0.04). Leakage along the drain occurred more frequently in short stay patients (21 v 10 patients, P=0.04). The two groups did not differ in scores for psychosocial problems (uncertainty, anxiety, loneliness, disturbed sleep, loss of control, threat to self esteem), physical or psychological complaints, or in the coping strategies used. Before surgery, short stay patients scored higher on scales of depression (P=0.03) and after surgery they were more likely to discuss their disease with their families (at 1 month P=0.004, at 4 months P=0.04).
                Early discharge from hospital after surgery for breast cancer is safe and is well received by patients. Early discharge seems to enhance the opportunity for social support within the family. The purpose of this study was to evaluate the use of negative pressure wound therapy (NPWT) to improve wound healing after total hip arthroplasty (THA) and its influence on the development of postoperative seromas in the wound area.
                The study is a prospective randomised evaluation of NPWT in patients with large surgical wounds after THA, randomising patients to either a standard dressing (group A) or a NPWT (group B) over the wound area. The wound area was examined with ultrasound to measure the postoperative seromas in both groups on the fifth and tenth postoperative days.
                There were 19 patients randomised in this study. Ten days after surgery, group A (ten patients, 70.5 ± 11.01 years of age) developed seromas with an average size of 5.08 ml and group B (nine patients, 66.22 ± 17.83 years of age) 1.97 ml. The difference was significant (p = 0.021).
                NPWT has been used on many different types of traumatic and non traumatic wounds. This prospective, randomised study has demonstrated decreased development of postoperative seromas in the wound and improved wound healing. A prospective randomized controlled trial (RCT) of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer.
                This study evaluates the use of a multimodal package in colorectal cancer surgery in the context of an RCT.
                Patients for elective resection for colorectal cancer were offered trial entry. Participants were stratified by sex and requirement for a total mesorectal excision and centrally randomized. Multimodal patients received intravenous fluid restriction, unrestricted oral intake with prokinetic agents, early ambulation, and fixed regimen epidural analgesia. Control patients received intravenous fluids to prevent oliguria, restricted oral intake until return of bowel motility, and weaning regimen epidural analgesia. Adherence to both regimens was reinforced using a daily checklist and protocol guidance sheets. Discharge decision was made using pre-agreed criteria. The primary endpoint was postoperative stay, and achievement of independence milestones. Secondary endpoints were postoperative complications, readmission rates, and mortality. Analysis was by intention to treat.
                Seventy patients were recruited. Approximately one fourth underwent TME. Median ages were similar (69.3 vs. 73.0 years). The median stay was significantly reduced in the multimodal group (5 vs. 7 days; P < 0.001, Mann-Whitney U test). Patients in the control arm were 2.5 times as likely to require a postoperative stay of more than 5 days. Patients in the multimodal group had less cardiorespiratory and anastomotic complications but more readmissions. There were 2 deaths, both controls.
                This RCT provides level 1b evidence that a multimodal management protocol can significantly reduce postoperative stay following colorectal cancer surgery. Morbidity and mortality are not increased. The increased use of laparoscopic colectomy for colon cancer requires the evaluation of hospital case volume, quality care, and training systems, considering the difficulty of this surgery for various tumor locations.
                We assessed the quality of this procedure in Japan, based on hospital case volume and tumor location. A total of 3,765 patients were enrolled across 567 hospitals between July and December 2007. We analyzed patient characteristics, postoperative surgical complications, the administration of stapling devices or chemotherapy, hospital volume and teaching status, postoperative length of stay, total charges, and operating room time. Hospitals were classified into four case-volume categories: high (> or =5 cases per month), intermediate to high (3-4), low to intermediate (1-2), and low (<1). Multivariate analysis was used to test the impact of hospital category and tumor location.
                Ten high-volume hospitals performed 401 cases, while 355 low-volume hospitals did 903. Hospital case volume, operating time, and complications affected postoperative stay and total costs. Longer procedural time was an independent predictor of complications. Tumor location, case volume, and teaching status explained the variations in procedural time individually but not complications. Training systems highlighting the applicability of techniques are important to promote the quality of laparoscopic colectomy. The influence of primary systemic therapy in treating operable breast cancer on postmastectomy morbidity rates was investigated. The contribution of other risk factors was assessed by multiple logistic regression. Seventy-nine eligible patients were randomly allocated, 39 to undergo immediate modified radical mastectomy, and 40 to receive initial cytotoxic or endocrine treatment followed by mastectomy. Postoperative wound seroma, infection and necrosis were recorded prospectively. Fourteen minor and six major complications occurred in 17 patients treated conventionally, while 14 patients developed 11 minor and six major complications after systemic therapy (P > 0.4). Median hospital stay was 8 days for both groups. Age, smoking, immediate breast reconstruction and the type of primary systemic treatment given were not independent predictors of complication risk. Obesity emerged as a significant risk factor for postmastectomy complications (P = 0.015). Primary systemic therapy does not increase the rate of morbidity after mastectomy. This study investigated the effects of Gentacoll implants on healing in patients (n = 44) undergoing modified radical mastectomy and axillary dissection. Group I, the Gentacoll group (n = 22), underwent surgery followed by insertion of 10 × 10 × 0.5 cm Gentacoll implants (280 mg collagen sponge plus 200 mg gentamicin sulphate) into the axillary area and under the flap area of the breast before wound closure. Group II, the control group (n = 22), underwent surgery without the application of Gentacoll. Neither group received oral or parenteral post-operative antibiotic therapy. Outcome measures included wound infection, seroma formation, total drainage volumes, drain removal time and duration of hospital stay. Post-operative infection rate, seroma formation, drainage volumes and duration of hospital stay were significantly reduced in the Gentacoll group compared with the control group. In conclusion, the application of Gentacoll significantly improved post-operative outcomes in patients undergoing modified radical mastectomy. The impact on wound infection of the addition of perioperative cefamandole to a mechanical bowel preparation with oral antibiotics was studied in a prospective randomized series of patients undergoing elective colectomy for biopsy-proven carcinoma or adenomatous polyps. Seventy patients were randomized, all underwent mechanical bowel preparation and received oral neomycin and erythromycin base. Thirty-four patients also received a preoperative and four postoperative doses of cefamandole, while 36 patients were randomized to receive no parenteral antibiotics. The two groups were well stratified for age, sex, and risk factors. The Dukes stage was similar and the surgical procedures were equally distributed in the two groups. There were no wound infections in the 34 patients receiving cefamandole and only one wound infection (2.8 percent) in the 36 control patients. Therefore, the addition of perioperative intravenous cefamandole to a good mechanical bowel preparation with oral antibiotics was of no benefit in reducing wound infections following resection of colorectal malignancies in this select group of patients. The aim of the study was to investigate the impact of hospital caseload on the short-term postoperative outcome of patients with rectal carcinoma.
                A multicentre study involving 75 German hospitals was carried out between January and December 1999. Some 1463 patients with rectal carcinoma were studied.
                The hospitals were divided into three groups by annual caseload as follows: less than 20 (group 1), 20-40 (group 2) and more than 40 (group 3). The groups were identical in terms of age, gender, height, weight, tumour stage, risk factors and American Society of Anesthesiologists classification. Postoperative morbidity was less in hospitals with a case volume of more than 20 patients per year (41.7 per cent in group 2 versus 49.9 per cent in group 1). The proportion of patients undergoing abdominoperineal resection with a permanent stoma was less in hospitals with a case volume of more than 40 patients per year (26.4 per cent in group 3 versus 34.0 per cent in group 2).
                A large caseload in rectal surgery results in a significant reduction in permanent stoma formation and postoperative morbidity. The aim of this study was to evaluate the effect of antibiotic prophylaxis on the development of infectious complications in laparoscopic cholecystectomy.
                A total of 208 patients undergoing elective laparoscopic cholecystectomy were randomized, double-blinded into one of two treatment arms: 1) cefazolin 1 g intravenously after induction of anesthesia and 2) no prophylactic antibiotics. The patients were followed-up for infectious complications for 30 days at the out-patient clinic. The data collected included age, sex, body mass index, ultrasonography findings, accompanying diseases, perforation during surgery, stone spillage, operation time, port of gallbladder delivery, suture material used for skin closure, preoperative and length of postoperative hospitalization, bile culture, pathology of the gallbladder, serum biochemical findings including alanine aminotransferase, aspartate aminotransferase, gammaglutamyl transpeptidase, bilirubin, alkaline phosphatase and glucose.
                Overall rate of infection was 3.36%. Four out of 105 patients who received antibiotics and 3 out of 103 patients who did not receive antibiotics developed infection. The difference was not statistically significant. Obesity and closing the skin with nylon sutures were found to be associated with increased rate of infectious complications.
                Cefazolin prophylaxis in low risk patients has no effect on postoperative infection rate in laparoscopic cholecystectomy. Seroma formation is a frequently occurring complication in patients operated on because of breast cancer. This complication can be the cause of flap necrosis, can lead to infection, and can prolong the hospital stay. It can also cause a delay in chemotherapy and radiotherapy. In order to prevent seroma formation, various methods such as external compression dressings, immobilization of the arm, sclerotherapy, and suction drainage have been used, without much success. In animal models and some clinical studies, it has been stated that fibrin glue reduces seroma formation, and these statements generated high expectations. For this reason, a prospective study was planned to test this in patients who underwent modified radical mastectomy (MRM) because of breast cancer. Of the 54 patients studied, 27 patients had fibrin glue (4 ml) applied to wound surfaces and under the flap (study group); the remaining 27 patients were the control group. Daily drainage volumes, total amount of drainage, drain removal time, and seroma formation were recorded and compared between the two groups. The first-day drainage was significantly lower in the study group (p<0.05, Student's t-test). There were no significant differences in daily drainage volumes, drain removal time, seroma formation frequency, and the number of seromas between the two groups (p>0.05). In conclusion; fibrin glue application had no significant benefit on axillary lymphatic drainage, drain removal time, or seroma formation. Postoperative mortality after some types of cancer surgery is inversely related to the number of operations performed at a hospital (i.e., hospital volume). This study assessed the association of hospital volume with colostomy rates and survival for patients with rectal cancer in a large representative cohort identified from the California Cancer Registry.
                We identified 7257 patients diagnosed from January 1, 1994, through December 31, 1997, with stage I-III rectal cancer who underwent surgical resection. Registry data were linked to hospital discharge abstracts and ZIP-code-level data from the 1990 U.S. Census. Associations of hospital volume with permanent colostomy and 30-day mortality were assessed with the Mantel-Haenszel trend test and logistic regression. Overall survival was examined with the Kaplan-Meier method and a multivariable Cox proportional hazards model. Multivariable analyses adjusted for demographic and clinical variables and patient clustering within hospitals. All tests of statistical significance were two-sided.
                In unadjusted analyses across decreasing quartiles of hospital volume, we observed statistically significant increases in colostomy rates (29.5%, 31.8%, 35.2%, and 36.6%; P<.001) and in 30-day postoperative mortality (1.6%, 1.6%, 2.9%, and 4.8%; P<.001) and a decrease in 2-year survival (83.7%, 83.2%, 80.9%, and 76.6%; P<.001). The adjusted risks of permanent colostomy (odds ratio [OR] = 1.37, 95% confidence interval [CI] = 1.10 to 1.70), 30-day mortality (OR = 2.64, 95% CI = 1.41 to 4.93), and 2-year mortality (hazard ratio = 1.28, 95% CI = 1.15 to 1.44) were greater for patients at hospitals in the lowest volume quartile than for patients at hospitals in the highest volume quartile. Stratification by tumor stage and comorbidity index did not appreciably affect the results. Adjusted colostomy rates varied statistically significantly (P<.001) among individual hospitals independent of volume.
                Rectal cancer patients who underwent surgery at high-volume hospitals were less likely to have a permanent colostomy and had better survival rates than those treated in low-volume hospitals. Identifying processes of care that contribute to these differences may improve patients' outcomes in all hospitals.
FG did not influence the incidence of postoperative seroma, the mean volume of seroma, wound infections, complications and the length of hospital stays in people undergoing breast cancer surgery. Due to significant methodological and clinical diversity among the included studies this conclusion may be considered weak and biased. Therefore, a major multicentre and high-quality RCT is required to validate these findings.