Swedish Rectal Cancer Registry Research Articles

Costs Related to Diverting Ileostomy After Rectal Cancer Surgery: A Population-Based Healthcare Cost Analysis Based on Nationwide Registers.

Low anterior resection for rectal cancer often includes a diverting loop-ileostomy to avoid the severe consequences of anastomotic leakage. Reversal of the stoma is often delayed, which can incur health-care costs on different levels. The aim is to, on population basis, determine stoma-related costs, and to investigate habitual and socioeconomic factors associated to the level of cost. Multi-register design with data from the Swedish Rectal Cancer Registry, the National Prescribed Drug Register, Statistics Sweden and cost-administrative data from the National Board of Health and Welfare. Data was gathered for 3564 patients with rectal cancer surgery 2007 to 2013, for 3 years following the surgery. Factors influencing the cost of inpatient care and stoma-related consumables were assessed with linear regression analyses. All monthly costs were higher for females (consumables P < .001 and in-patient care P = .031). Post-secondary education (P = .003) and younger age (P = .020) was associated with a higher cost for consumables while suffering a surgical complication was associated with increased cost for inpatient care (P < .001). Patients who had their stoma longer had lower monthly costs (consumables P < .001 and in-patient care P < .001). Female gender, longer duration of stoma, young age, and higher education are associated with higher costs for the care of a diverting stoma after rectal cancer surgery. This study does not allow for analyses of causality but the results together with deepened analyses of underlying reasons form a proper basis for decisions in health care planning and allocation of resources. These findings may have implications on the debate of equal care for all.

Long distance to hospital is not a risk factor for non-reversal of a defunctioning stoma

PurposeTo see if road distance to hospital influences stoma reversal rate, time from index operation to stoma reversal, and occurrence of permanent stoma.MethodsData from all diagnosed cases of rectal cancer from three counties in northern Sweden were extracted from the Swedish Rectal Cancer Registry. The three counties are sparsely populated, with a population density roughly one fifth the average density in Sweden. Distances to nearest, operating, and largest hospital were obtained using Google Maps™. Matched data on socioeconomic variables were retrieved from Statistics Sweden.ResultsIn univariate logistic regression analysis, patients living closer to the operating hospital had a higher likelihood of non-reversal than those living farther away (OR 0.3; 95% CI 0.12–0.76). However, no difference was seen in the multivariate analysis. Of the 717 cases included, 54% received a permanent stoma and 38% a defunctioning stoma at index surgery. The reversal rate of a defunctioning stoma was 83%. At follow-up, 61% still had a stoma, 89% of these were permanent, and 11% non-reversed defunctioning stomas. Median time to stoma reversal was 287 days (82–1557 days). Of all 227 stoma reversals, 77% were done more than 6 months after index surgery.ConclusionsLonger distance to hospital is not a risk factor for non-reversal of a defunctioning stoma. Only 23% had their defunctioning stoma reversed within 6 months after index surgery. Future studies aiming to determine reversal rate need to extend their follow-up time in order to receive accurate results.

Socioeconomic inequalities in relative survival of rectal cancer most obvious in stage III.

The association between socioeconomic status (SES) and relative survival of rectal cancer is little investigated. We hypothesized that the impact on risk of death by SES would be much smaller when differences in background mortality (comorbidity, lifestyle factors) were taken into account, i.e. in modelling relative survival of rectal cancer. Individual data on civil status, education, and income were linked to the Swedish Rectal Cancer Registry 1995-2005 (n = 16,713). Specific life tables by socioeconomic group were used to calculate relative survival, and modelling included age, sex, stage, time period, and SES. The same covariates were applied in a Cox regression based on absolute survival. Stage distribution was associated with civil status, education, and income (p < 0.001). In spite of modelling based on relative survival, an increased risk of death was found for all other patients compared with those who were married, as well as for all other patients compared with those with the highest income. The pattern was fundamentally the same as in a Cox regression model, only the point estimates were slightly reduced using the relative approach. In stage-specific modelling of relative survival, income was of particular importance in stage III; the hazard ratio (HR) for lowest versus the highest income was 1.37 [95 % confidence interval (CI) 1.15-1.64]. There were also significant differences by income among patients who had a major surgical resection (stage IV excluded). Large and clinically relevant socioeconomic inequalities remained in stage-adjusted analyses of relative survival, also in a setting of universal healthcare and no screening program operating.

Extralevator abdominoperineal excision (ELAPE) for rectal cancer--short-term results from the Swedish Colorectal Cancer Registry. Selective use of ELAPE warranted.

PurposeLocal recurrences are more common after abdominoperineal excision (APE) than after anterior resection of rectal cancer. Extralevator APE was introduced to address this problem. This prospective registry-based population study aims to investigate the efficacy of extralevator APE (ELAPE) in improving short-term oncological outcome.MethodsAll Swedish patients operated with any kind of abdominoperineal excision and registered in the Swedish Rectal Cancer Registry 2007–2009 were included (n = 1,397) and analyzed with emphasis on the perineal part of the operation. Short-term perioperative and oncological results were collected from the registry.ResultsExtralevator APE did not result in fewer intraoperative perforations or involved circumferential resection margins as compared to standard APE for the entire group. Intraoperative perforations were significantly fewer for patients with low tumours (≤4 cm) (ELAPE: n = 28/386 versus APE: n = 9/58) (p = 0.043) and for early (T0–T2) T-stages (ELAPE: n = 3/172 versus APE: n = 6/75) (p = 0.025). There were significantly more post-operative wound infections for ELAPE than for APE (n = 106 (20.4 %) versus n = 25 (12.0 %), p = 0.011).ConclusionsThe short-term results indicate that selective use of extralevator APE can be warranted, for example, for subgroups with low tumours. In conclusion, selective use of the extralevator APE is advocated as not all patients seem to benefit from the technique, and there are significantly more short-term complications after extralevator APE.

Validity of the Swedish Rectal Cancer Registry for patients treated with major abdominal surgery between 1995 and 1997

Background. Founded in 1995, the Swedish Rectal Cancer Registry (SRCR) is frequently used for rectal cancer research. However, the validity of the registry has not been extensively studied. This study aims to validate a large amount of registry data to assess SRCR quality. Material and methods. The study comprises 906 patients treated with major abdominal surgery registered in the SRCR between 1995 and 1997. SRCR data for 14 variables were scrutinized for validity against the medical records. Kappa's and Kendall's correlation coefficients for agreement between SRCR data and medical records data were calculated for 13 variables. Results. For 11 variables, concerning the tumor, neoadjuvant therapy, the surgical procedure, local radicality and TNM stage, data were missing in 5% or less of the registrations; for the remaining three variables, anastomotic leakage, local and distant recurrence, data were missing in 13–38%. For the variables surgery performed or not and type of surgical procedure, no data were missing. Erroneous registrations were found in less than 10% of all variables; for the variables preoperative chemotherapy and surgery performed or not, all registrations were correct. For the variables concerning neoadjuvant therapy, local radicality according to the surgeon as well as the pathologist and distant metastasis, the false-positive or -negative registrations were equally distributed, and for the variables rectal washout, rectal perforation, anastomotic leakage and local recurrence there was a discrepancy in distribution. The correlation coefficient for 12 variables ranged from 0.82 to 1.00, and was 0.78 for the remaining variable. Conclusion. The validity of the SRCR was good for the initial three registry years. Thus, research based on SRCR data is reliable from the beginning of the registry's use.

145. Swedish rectal cancer registry – Implications of national auditing on patients' care

145. Swedish rectal cancer registry – Implications of national auditing on patients' care

Treatment strategies for patients with stage IV rectal cancer: A report from the Swedish Rectal Cancer Registry

BackgroundThe optimal treatment strategy for patients with stage IV rectal cancer is unclear. The aim of the present study was to describe trends and compare the different treatment strategies for this group of patients at a national level and over time. MethodsData from 2758 rectal cancer patients with (stage IV) and 13,420 without metastases (stage I–III) were available from the Swedish Rectal Cancer Registry between January 1995 and December 2006. ResultsPatients with stage IV disease increased from 15% to 19% between 1995 and 2006 (p<0.001) and the frequency of patients not operated on increased from 13% to 26% (p<0.001). Postoperative 30day mortality after bowel resection was 2% and after exploratory laparotomy 9%. Median survival for stage IV patients after bowel resection was 16.3months, exploratory laparotomy 6.1months and for patients having no surgery 4.6months. Over time survival was improved for patients aged 60–69years, irrespective of the treatment given. An increased risk of death was associated with: age >80years, operation at a local hospital, treatment in earlier time periods, not receiving preoperative radio- or chemotherapy and not having a bowel resection. ConclusionsIn the latest time period survival was improved for rectal cancer patients in stage IV despite the great increase in non-operated patients. Patients aged >80years should be carefully assessed and staged before surgery. The survival advantage for stage IV rectal cancer patients who underwent primary tumour resection is probably due to selection to more favourable cases.

Anastomotic leakage after surgery for rectal cancer: a risk factor for local recurrence, distant metastasis and reduced cancer‐specific survival?

The impact of anastomic leakage (AL) on the oncological outcome after anterior resection (AR) for rectal cancer is still controversial. We explored the impact of AL regarding local recurrence (LR), distant metastasis and overall recurrence (OAR). Overall and cancer-specific survival was analysed. Patients undergoing AR for rectal cancer with a registered AL between 1995 and 1997 and a control group were identified in the Swedish Rectal Cancer Registry. The medical records were retrieved for additional data and validation. Differences in the oncological outcome at 5-year follow-up were analysed with multivariate methods. After validation, 114 patients with AL and 136 control patients with locally radical surgery for tumours in tumour-node-metastasis stages I-III were analysed. There was no difference detected between patients with AL and control patients regarding rates of LR [8% (9 of 114) vs 9% (12 of 136); P = 0.97], distant metastasis [18% (20 of 114) vs 23% (31 of 136); P = 0.37] and OAR [19% (22 of 114) vs 28% (38 of 136); P = 0.15]. The 5-year cancer-specific survival was almost 80% in both groups. In multivariate analysis, AL was not a risk factor of LR, distant metastasis or OAR and had no impact on 5-year overall or 5-year cancer-specific survival. Irrespective of the occurrence of AL, preoperative radiotherapy (P = 0.055) and rectal washout (P = 0.046) reduced the LR rate, but did not influence survival. Anastomotic leakage was not proved to be a risk factor of worse oncological outcome. Hence, additional adjuvant treatment or extended follow-up on the basis of the occurrence of AL after AR might not be justified.

Reply by Authors

No AccessJournal of UrologyAdult Urology1 Mar 2011Reply by Authors View All Author Informationhttps://doi.org/10.1016/j.juro.2010.10.090AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "Reply by Authors." The Journal of Urology, 185(3), p. 840 References 1 : Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. J Clin Oncol2007; 25: 1596. Google Scholar 2 : Time trends and local variation in primary treatment of localized prostate cancer. J Clin Oncol2010; 28: 1117. Google Scholar 3 : The Swedish rectal cancer registry. Br J Surg2007; 94: 1285. Google Scholar 4 : The Swedish hernia register. In: Recurrent Hernia: Prevention and Treatment. Edited by . Berlin: Springer-Verlag2007. Google Scholar 5 : Presidential guest address: the Swedish Hip Registry: increasing the sensitivity by patient outcome data. Clin Orthop Relat Res2005; 441: 19. Google Scholar © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 3March 2011Page: 840 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Expand All Advertisement PDF downloadLoading ...

Sphincter preservation in rectal cancer is associated with patients' socioeconomic status

Decision making regarding the choice of surgical procedure in rectal cancer is complex. It was hypothesized that, in addition to clinical factors, several aspects of patients' socioeconomic background influence this process. Individually attained data on civil status, education and income were linked to the Swedish Rectal Cancer Registry 1995-2005 (16 713 patients) and analysed by logistic regression. Anterior resection (AR) was performed in 7433 patients (44.5 per cent), abdominoperineal resection (APR) in 3808 (22.8 per cent) and Hartmann's procedure in 1704 (10.2 per cent). Unmarried patients were least likely (odds ratio (OR) 0.76, 95 per cent confidence interval (c.i.) 0.64 to 0.88) and university-educated men were most likely (OR 1.30, 1.04 to 1.62) to have an AR. Patients with the highest income were more likely to undergo AR (OR 0.80, 0.85 and 0.86 respectively for first, second and third income quartiles). Socioeconomic differences in the use of AR were smallest among the youngest patients. Unmarried patients were more likely (OR 1.21, 95 per cent c.i. 1.00 to 1.48) and university-educated patients less likely (OR 0.78, 95 per cent c.i. 0.63 to 0.98) to have an APR. The choice of surgical strategy in rectal cancer is not socioeconomically neutral. Confounding factors, such as co-morbidity or smoking, may explain some of the differences but inequality in treatment is also plausible.

Socioeconomic inequalities in the use of radiotherapy for rectal cancer: A nationwide study

Preoperative radiotherapy (PRT) in rectal cancer reduces the risk of local recurrence by at least half but the influence of the socioeconomic status of patients on the use of PRT is little investigated in Europe. MethodsIndividually attained data on civil status, education and income were linked to the Swedish Rectal Cancer Registry 1995–2005 (n=16,713) and analysed by logistic regression. ResultsForty-six percentage of the patients received PRT and the crude rate varied with age, gender, civil status, education and income as well as with sublocalisation, stage, type of hospital and health care region. In a multivariate analysis, all civil status groups had PRT to a lesser extent compared with married patients; odds ratio (OR) for unmarried patients was 0.67 (95% confidence interval (CI) 0.59–0.76). Patients with secondary and university education had PRT to the same extent as those with compulsory school (OR 1.04 (0.94–1.15) and 0.92 (0.81–1.06)). The use of PRT was associated with income; OR for patients with income Q1 versus Q4 was 0.76 (0.67–0.86). The inequalities by civil status and income remained unchanged also in groups with a relatively stronger indication for adjuvant radiotherapy, i.e. younger patients and in low rectal cancer. ConclusionUnmarried and low-income patients are at increased risk for not receiving PRT in rectal cancer. Comorbidity may explain some differences but increased awareness of the role of non-medical variables for the use of PRT is warranted.

Oncological outcome after incidental perforation in radical rectal cancer surgery

Identification of risk factors of poor oncological outcome in rectal cancer surgery is of utmost importance. This study examines the impact of incidental perforation on the oncological outcome. Using the Swedish Rectal Cancer Registry, patients were selected who received major abdominal surgery for rectal cancer between 1995 and 1997 with registered incidental perforation. A control group was also selected for analysis of the oncological outcome after 5-year follow-up. Multivariate analysis was performed. Registry data were validated, and additional data were supplemented from medical records. After validation and exclusion of non-radically operated patients, 118 patients with incidental perforation and 155 controls in TNM stages I-III were included in the analysis. The rate of local recurrence (LR) [20% (23/118) vs. 8% (12/155) (p = 0.007)] was significantly higher among patients with perforation, whereas the rates of distant metastasis [27% (32/118) vs. 21% (33/155) (p = 0.33)] and overall recurrence (OAR) [35% (41/118) vs. 25% (38/155) (p = 0.087)] were not significantly different between the groups. Overall as well as cancer-specific 5-year survival rates were significantly reduced for the patients with perforation [44 vs. 64% (p = 0.002) and 66 vs. 80% (p = 0.026), respectively]. In the multivariate analysis, perforation was a significant risk factor of increased rates of LR and OAR as well as reduced 5-year overall and cancer-specific survival. Incidental perforation in rectal cancer surgery is an important risk factor of poor oncological outcome and should be considered in the discussion concerning postoperative adjuvant treatment as well as the follow-up regime.

The Impact of Hospital Volume on Surgical Outcome in Patients with Rectal Cancer

This study was designed to investigate, in a population-based setting, the surgical outcome in patients with rectal cancer according to the hospital volume. Since 1995 all patients with rectal cancer have been registered in the Swedish Rectal Cancer Registry. Hospitals were classified, according to number treated per year, as low-volume, intermediate-volume, or high-volume hospitals (<11, 11-25, or >25 procedures per year). Postoperative mortality, reoperation rate within 30 days, local recurrence rate, and overall five-year survival were studied. For postoperative morbidity and mortality the whole cohort from 1995 to 2003 (n = 10,425) was used. For cancer-related outcome only, those with five-year follow-ups, from 1995 to 1998, were used (n = 4,355). In this registry setting the postoperative mortality rate was 3.6% in low-volume hospitals, and 2.2% in intermediate-volume and high-volume hospitals (P = 0.002). The reoperation rate was 10%, with no differences according to volume. The overall local recurrence rates were 9.4%, 9.3%, and 7.5%, respectively (P = 0.06). Significant difference was found among the nonirradiated patients (P = 0.004), but not among the irradiated patients (P = 0.45). No differences were found according to volume in the absolute five-year survival. Postoperative mortality and local recurrence in nonirradiated patients were lower in high-volume hospitals. No difference was seen between volumes in reoperation rates, overall local recurrence, or absolute five-year survival.

Risk factors of rectal cancer local recurrence: population‐based survey and validation of the Swedish rectal cancer registry

Despite advances in rectal cancer treatment, local recurrence (LR) remains a significant problem. To select high-risk patients for different treatment options aimed at reducing LR, it is essential to identify LR risk factors. Local recurrence and survival rates of 4153 patients registered 1995-1997 in the Swedish Rectal Cancer Registry were analysed. LR risk factors were analysed by multivariate methods. For LR patients the registry was validated and additional data retrieved. The 5-year overall and cancer-specific survival rates were 45% and 62% respectively. LR was registered in 326 (8%) patients. After R0-resections for tumours in TNM stages I-III, LR developed in 10% of tumours at 0-5 cm, 8% at 6-10 cm and 6% at 11-15 cm above the anal verge. Preoperative radiotherapy (RT) reduced the LR rate irrespective of height [0-5 cm: OR 0.50 (0.30-0.83), 6-10 cm: OR 0.42 (0.25-0.71), and 11-15 cm: OR 0.29 (0.13-0.64)]. Patients without preoperative RT had significantly higher LR risk after rectal perforation [OR 2.50 (1.48-4.24)], and almost significantly decreased LR risk when rectal washout was performed [OR 0.65 (0.43-1.00)]. Preoperative RT prolonged time to LR but did not significantly influence the survival among LR patients. LR was an isolated tumour manifestation in 103 (39%) patients with validated LR. Preoperative RT should be considered for rectal cancer also in the upper third of the rectum. Intraoperative perforation should be avoided, and rectal washout is indicated as valuable. Follow-up for the detection of isolated LR is important. Extended follow up should be considered for patients treated with RT.

Rectal cancer treatment and outcome in the elderly: an audit based on the Swedish rectal cancer registry 1995–2004

BackgroundLimited information is available regarding the effect of age on choice of surgical and oncological treatment for rectal cancer. The objective of this study was to assess the influence of age on treatment and outcome of rectal cancer.MethodsWe utilized data in the Swedish Rectal Cancer Registry (SRCR) from patients treated for rectal cancer in Sweden in 1995–2004.ResultsA total of 15,104 patients with rectal cancer were identified, 42.4% of whom were 75 years or older. Patients ≥75 years were less likely to have distant metastases than younger patients (14.8% vs. 17.8%, P < 0.001), and underwent abdominal tumor resection less frequently (68.5% vs. 84.4%, P < 0.001). Of 11,725 patients with abdominal tumor resection (anterior resection [AR], abdominoperineal excision [APE], and Hartmann's procedure [HA]), 37.4% were ≥75 years. Curative surgery was registered for 85.0% of patients ≥ 75 years and for 83.9% of patients < 75 years, P = 0.11. Choice of abdominal operation differed significantly between the two age groups for both curative and non-curative surgery, The frequency of APE was similar in both age groups (29.5% vs. 28.6%), but patients ≥75 years were more likely to have HA (16.9% vs. 4.9%) and less likely to have preoperative radiotherapy (34.3vs. 67.2%, P < 0.001). The relative survival rate at five years for all patients treated with curative intent was 73% (70–75%) for patients ≥75 years and 78% (77–79%) for patients < 75 years of age. Local recurrence rate was 9% (8–11%) for older and 8% (7–9%) for younger patients.ConclusionTreatment of rectal cancer is influenced by patient's age. Future studies should include younger and older patients alike to reveal whether or not age-related differences are purposive. Local recurrence following surgery for low tumors and quality of life aspects deserve particular attention.

Risk factors for anastomotic leakage after rectal cancer surgery: a case‐control study

With introduction of the total mesorectal excision technique and preoperative radiotherapy in rectal cancer surgery, the local recurrence rate has decreased and the overall survival has improved. One drawback, however, is the high anastomotic leakage rate of approximately 10-18%. Male gender and low anastomoses are known risk factors for such leakage. The aim of this study was to identify potentially modifiable risk factors. In a case-control study, data from the Swedish Rectal Cancer Registry (1995-2000) were analysed. Cases were all patients with anastomotic leakage after an anterior resection (n = 134). Two controls were randomly selected for each case. The medical records (n = 402) were checked against a study protocol. Due to incorrect recording two cases and 28 controls were excluded from further analyses. In the multivariate analysis significant risk factors were American Society of Anesthesiologists score > 2 [OR = 1.40 (95% CI 1.05-1.83)], preoperative radiotherapy [OR = 1.34 (95% CI 1.06-1.69)], intraoperative adverse events [OR = 1.85 (95% CI 1.32-2.58)], level of anastomosis <or= 6 cm [OR = 1.39 (95% CI 1.01-1.90)] and severe bleeding [OR = 1.45 (95% CI 1.14-1.84)]. Diverting stoma protected from leakage [OR = 0.68 (95% CI 0.52-0.88)]. Male gender was a risk factor in the univariate but not in the multivariate analysis [OR = 1.30 (95% CI 1.04-1.63) and OR = 1.26 (95% CI 1.00-1.58), respectively]. Except for a protective stoma, none of the variables considered as possible targets for improvement, such as postoperative epidural anaesthesia, observation at intensive care unit for more than 24 h, and intraabdominal drainage, proved to be protective factors either in the univariate or in the multivariate analyses. The most important risk factors for leakage were adverse intraoperative events, low anastomoses and preoperative radiotherapy. A diverting stoma is protective and can reduce the consequences when leakage occurs. Further analyses with focus on the surgical technique and individual surgeon may be valuable in identifying targets for improvement.

The Swedish rectal cancer registry

An audit of all patients with rectal cancer in Sweden was launched in 1995. This is the first report from the Swedish Rectal Cancer Registry (SRCR). Between 1995 and 2003, 13 434 patients treated for adenocarcinoma of the rectum were registered with the SRCR; there were approximately 1500 new patients annually. Approximately half had an anterior resection, a quarter an abdominoperineal resection and 15 per cent a Hartmann's procedure. The median 30-day postoperative mortality rate was 2.4 per cent and the overall postoperative morbidity rate was 35.0 per cent. The 5-year cancer-specific survival rate was 62.3 per cent. The 5-year relative survival rate was 70.1 per cent after anterior resection, 59.8 per cent after abdominoperineal resection and 39.8 per cent after a Hartmann's procedure. The crude 5-year local recurrence rate was 9.5 per cent overall, 6.1 per cent after preoperative radiotherapy and 11.4 per cent after surgery alone. For 3868 patients who had a locally curative procedure the local recurrence rate was 7.4 per cent overall, 5.9 per cent for those who had radiotherapy and 10.2 per cent for those who did not. The local recurrence rate was 2.9 per cent (28 of 968) for stage I disease, 7.9 per cent (112 of 1418) for stage II, 13.9 per cent (188 of 1357) for stage III and 8.5 per cent (45 of 532) for stage IV. These good population-based results are due, in part, to the nationwide prospective quality assurance registration.

The circular stapling device as a risk factor for anastomotic leakage.

To investigate the relation between the type of circular stapler and anastomotic leak in rectal cancer surgery. During the past decades results from rectal cancer surgery have improved considerably regarding risk of local recurrence and survival. Two main paradigm changes are considered to be the cause for this: the introduction of total mesorectal excision (TME) and the increasing use of radiotherapy. However, rectal cancer surgery is associated with an unacceptably high frequency of complications of which anastomotic leak is one of the most severe ones. The hypothesis was raised that the choice of stapler influenced the leakage rates. A questionnaire was sent to all departments of surgery (n = 66) performing rectal cancer surgery in Sweden to determine the choice of circular stapler when performing anterior resection for rectal cancer. These data were linked to the Swedish Rectal Cancer Registry for the period 1995-99. A total of 3316 patients had an anterior resection. The choice of circular stapling device was determined in 70% of the cases. When stapler A was used, the leakage rate was 11% whereas it was 7% when stapler B was used (P = 0.0039). In the cases where it was impossible to determine which stapler had been used the leakage rate was 8%. Quality control is an important part of medicine and the present study suggests that it also must include surgical instruments. A prospective randomised study is needed to confirm the results.