What is the optimal management of an intra-operative air leak in a colorectal anastomosis?

AIM: An airtight anastomosis on intra-operative leak testing has been previously demonstrated to be associated with a lower risk of clinically significant postoperative anastomotic leak following left-sided colorectal anastomosis. However, to date, there is no consistently agreed upon method for management of an intra-operative anastomotic leak. Therefore, we powered a noninferiority study to determine whether suture repair alone was an appropriate strategy for the management of an intra-operative air leak. METHOD: This is a retrospective cohort analysis of prospectively collected data from a tertiary care referral centre. We included all consecutive patients with left-sided colorectal or ileorectal anastomoses and evidence of air leak during intra-operative leak testing. Patients were excluded if proximal diversion was planned preoperatively, a pre-existing proximal diversion was present at the time of surgery or an anastomosis was ultimately unable to be completed. The primary outcome measure was clinically significant anastomotic leak, as defined by the Surgical Infection Study Group at 30 days. RESULTS: From a sample of 2360 patients, 119 had an intra-operative air leak during leak testing. Sixty-eight patients underwent suture repair alone and 51 underwent proximal diversion or anastomotic reconstruction. The clinically significant leak rate was 9% (6/68; 95% CI: 2-15%) in the suture repair alone arm and 0% (0/51) in the diversion or reconstruction arm. CONCLUSION: Suture repair alone does not meet the criteria for noninferiority for the management of intra-operative air leak during left-sided colorectal anastomosis. Further repair of intra-operative air leak by suture repair alone should be reconsidered given these findings.

What are 30-day postoperative outcomes following splenic flexure mobilization during anterior resection?

BACKGROUND: The aim of this study was to determine whether mobilization of the splenic flexure during anterior resection is associated with an increased number of complications. METHODS: This is a retrospective cohort analysis of all non-emergent anterior resections with anastomosis (open and laparoscopic) between January 2005 and December 2009 from the American College of Surgeons National Surgical Quality Improvement Program. Infectious, renal, and pulmonary adverse events as well as operative times were analyzed for cases with splenic flexure mobilization as compared to no mobilization. We then constructed multivariate models to identify risk factors for postsurgical adverse events. RESULTS: During the 5-year study period, 6,324 (57 %) open resections and 4,788 (43 %) laparoscopic resections were performed. Mobilization of the splenic flexure was associated with an increase in operating room time (204 vs 172 min, p < 0.0001). Although anastomotic leaks were not recorded, there was no difference in organ space infections (3.9 vs 3.7 %, p = 0.7) or return to operating room events between the two groups. However, patients who underwent splenic flexure mobilization had significantly more superficial surgical site infections (10.6 vs 8.4 %, p < 0.0002). Multivariate analysis accounting for laparoscopic or open surgery and standard preoperative and intraoperative variables demonstrated a persistent increase in superficial surgical site infections for patients with splenic flexure mobilization. CONCLUSIONS: Operating room times are longer and superficial surgical site infections are more common when the splenic flexure is mobilized. The absolute indications for splenic flexure mobilization should be addressed in further research.

Removal of TSE agent from plasma products manufactured in the United Kingdom.

BACKGROUND AND OBJECTIVES: The outbreak of vCJD in the UK leads to concern regarding the potential for human-to-human transmission of this agent. Plasma-derived products such as albumin, immunoglobulin and coagulation factors were manufactured by BPL from UK plasma up until 1999 when a switch to US plasma was made. In the current study, the capacity of various manufacturing processes that were in use both prior to and after this time to remove the TSE agent was tested. MATERIALS AND METHODS: Small-scale models of the various product manufacturing steps were developed. Intermediates were spiked with scrapie brain extract and then further processed. Samples were assayed for the abnormal form of prion protein (PrP(SC) ) by Western blotting, and the reduction in the amount of scrapie agent determined. RESULTS: Many of the manufacturing process steps produced significant reduction in the scrapie agent. Particularly effective were steps such as ethanol fractionation, depth filtration, ion-exchange and copper chelate affinity chromatography. Virus retentive filters, of nominal pore size 15 or 20 nm, removed >3 log. The total cumulative reduction capacity for individual products was estimated to range from 7 to 14 log. In the case of factor VIII (8Y), the total removal was limited to 3 log. CONCLUSION: All the processes showed a substantial capacity to remove the TSE agent. However, this was more limited for the intermediate purity factor VIII 8Y which included fewer manufacturing steps.

How often do patients return to the operating room after colorectal resections?

AIM: We sought to identify the rate of re-operation after an index colorectal surgical procedure and potential contributing risk factors. METHOD: This is a retrospective cohort study from the American College of Surgeons National Surgical Quality Improvement Program. We identified all patients who either returned or did not return to the operating room after any colorectal resection from January 2005 to December 2008. RESULTS: From a total cohort of 635, 265 patients included in the National Surgical Quality Improvement Program over the 4-year study period, we identified 54, 237 patients who underwent colorectal operations. A return to the operating room was coded in 5.4 ± 0.1% of non colorectal resection patients and 7.6 ± 0.2% of colorectal resection patients (P < 0.001). The multivariate model identified patients with postoperative diagnostic codes for abdominal cavity hernia or colostomy complication as having the highest odds of return to the operating room within 30 days. Patients returning to the operating room had longer length of stay and higher overall mortality compared with those patients who did not return to the operating room. CONCLUSION: Return to the operating room is a relatively common occurrence after colorectal resections, with an associated high rate of mortality. Given the association between return to the operating room and adverse patient outcomes, emphasis should be placed on determining strategies to reduce the need for return to the operating room.

Prostate cancer treatment ascertained from several sources: analysis of disagreement and error.

BACKGROUND: Treatment data for prostate cancer can be obtained from a variety of sources. Each of these sources has its own strengths and weaknesses and is subject to error. MATERIALS AND METHODS: In a population-based cohort of 319 prostate cancer patients, data on treatment were obtained from five sources: two patient interviews at 6 and 12 months after diagnosis, primary caregiver interviews, physician questionnaires, and medical records. Inter-reporting agreement and accuracy of reporting (compared with medical records) were assessed. Multivariate analyses examined patient, caregiver, and physician characteristics as determinants of reporting error. RESULTS: The agreement among different reporting methods was generally good to excellent for prostatectomy and brachytherapy (kappa range 0.70-0.90) and fair to good (kappa range 0.35-0.75) for external beam radiation and hormonal treatment. Compared with medical records, the interview- and questionnaire-based data collection methods were more accurate for prostatectomy and brachytherapy than for external beam radiation and hormonal therapy. Using medical records as the 'gold standard', patient and caregiver interviews at 6 months after the diagnosis had higher sensitivity and specificity than other reporting sources. CONCLUSION: Interviews of prostate cancer patients and caregivers are useful alternatives to medical record abstraction, particularly if carried out during, or soon after, treatment.

Prospective cohort study of microbial and inflammatory events immediately preceding Escherichia coli recurrent urinary tract infection in women.

BACKGROUND: A prospective cohort study was conducted to characterize the temporal sequence of microbial and inflammatory events immediately preceding Escherichia coli recurrent urinary tract infection (rUTI). METHODS: Women with acute cystitis and a history of UTI within the previous year self-collected periurethral and urine samples daily and recorded measurements of urine leukocyte esterase, symptoms, and sexual intercourse daily for 3 months. rUTI strains were characterized by pulsed-field gel electrophoresis and genomic virulence profiling. Urinary cytokine levels were measured. RESULTS: There were 38 E. coli rUTIs in 29 of 104 women. The prevalence of periurethral rUTI strain carriage increased from 46% to 90% during the 14 days immediately preceding rUTI, with similar increases in same-strain bacteriuria (from 7% to 69%), leukocyte esterase (from 31% to 64%), and symptoms (from 3% to 43%), most notably 2-3 days before rUTI (P<.05 for all comparisons). Intercourse with periurethral carriage of the rUTI strain also increased before rUTI (P=.008). Recurrent UTIs preceded by bacteriuria, pyuria, and symptoms were caused by strains less likely to have P fimbriae than other rUTI strains (P=.002). CONCLUSIONS: Among women with frequent rUTIs, the prevalences of periurethral rUTI strain carriage, bacteriuria, pyuria, and intercourse dramatically increase over the days preceding rUTI. A better understanding of the pathogenesis of rUTI will lead to better prevention strategies.

Effect of manufacturing process parameters on virus inactivation by dry heat treatment at 80 degrees C in factor VIII.

BACKGROUND AND OBJECTIVES: Dry heat treatment at 80 degrees C for 72 h is used as a virus inactivation step for some coagulation factor concentrates such as Bio Products Laboratory's (BPL) factor VIII 8Y. In the current study, the effect of this process has been tested on a range of viruses. In addition the effect of various manufacturing process parameters on virus inactivation has been investigated. MATERIALS AND METHODS: Samples of product intermediate were obtained from manufacturing, spiked with virus and subjected to freeze drying and dry heat treatment. Virus inactivation was determined by infectivity assay. RESULTS: Freeze drying followed by dry heat treatment was effective for inactivating a wide range of enveloped and nonenveloped viruses. Sucrose or protein concentration had no effect on virus inactivation. Product presentation or the interruption of heat treatment also had no effect. The inactivation of some of the viruses was greater at higher residual water content but under such conditions the stability of the product was reduced. CONCLUSION: This virus inactivation step was effective for a wide range of viruses and over the range of process conditions encountered in manufacturing. This demonstrates the robustness of this process step.

Vascular pedicle ligation techniques during laparoscopic colectomy. A prospective randomized trial.

BACKGROUND: A variety of devices are available for pedicle ligation during laparoscopic colectomy including vascular staplers, clips, and electrothermal bipolar vessel-sealing devices. This study assesses their speed, reliability, and cost to guide surgeons in their choice for intracorporeal pedicle ligation. METHODS: A prospective randomized study comparing laparoscopic vascular staplers and disposable clip appliers (S/C) with the LigaSure Atlas (LIG) was performed during elective right, left, and total colectomy. Cases were stratified by procedure. Failure was defined as any bleeding after proper pedicle ligation. RESULTS: The study included 48 S/C patients and 52 LIG patients with no differences in demographics, diagnosis, procedure, number of vessels ligated per procedure, or operative time. Failure occurred for 14 (9.2%) of the 152 vessels ligated in the S/C group, as compared with 5 (3%) of the 169 vessels ligated in the LIG group (p = 0.02). The median blood loss associated with device failure was 50 ml (range, 20-50 ml) in S/C group, as compared with 100 ml (range 25-800 ml) in the LIG group (p = 0.054). Major blood loss attributable to device failure and surgeon error occurred in only one LIG case. The mean cost per case of vessel ligation was significantly less in the LIG group (317 dollars +/- 0 dollars vs 400 dollars +/- 112 dollars; p < 0.001). The cost differences were greatest for total colectomy (LIG = 317 dollars +/- 0 dollars vs S/C = 565 dollars +/- 67 dollars; p = 0.002). CONCLUSION: Device failure, although more common in the S/C group, does not result in significant blood loss. The LigaSure Atlas is more cost effective during laparoscopic colectomy, especially total colectomy, and may allow the surgeon more versatility in its application.

Hand-assisted laparoscopic sigmoid colectomy: helping hand or hindrance?

BACKGROUND: Hand-assisted laparoscopic colectomy has been introduced as an alternative to the standard laparoscopic technique, but it has not yet been established whether it offers the same benefits. Therefore, we compared the outcome of patients undergoing hand-assisted laparoscopic sigmoid resection (HALSR) to that of those undergoing laparoscopic sigmoid resection (LSR). METHODS: The study population comprised a sequential series of consecutive patients undergoing elective laparoscopic sigmoid/left colectomy. Values are reported as mean (range). RESULTS: There were 85 LSR patients and 66 HALSR patients, with no differences in patient demographics or diagnoses. There were slight differences in operative time favoring HALSR (LSR 205 min (90-380) vs HALSR 189 min (120-290); p = 0.07), and the extraction incision was larger in the HALSR group (LSR 6.2 cm (3-25) vs HALSR 8.1 cm (7-12); p < 0.01). There was no difference in time for return of bowel function (LSR 2.8 days (1-15) vs HALSR 2.5 days (1-8); p = 0.31) or length of hospital stay (LSR 5.0 days (2-17) vs HALSR 5.2 days (3-22); p = 0.73). Complications were similar in the two groups (LSR 23% vs HALSR 21%), but there were fewer conversions in the hand-assisted group (HALSR 0% vs LSR 13%; p < 0.01). CONCLUSIONS: Hand-assisted laparoscopic sigmoid resection yields the same outcomes as standard laparoscopic techniques, but with fewer conversions. Hand-assistance is a helpful innovation that may expand the application of laparoscopic colectomy.

Effect of manufacturing process parameters on virus inactivation by solvent-detergent treatment in a high-purity factor IX concentrate.

BACKGROUND AND OBJECTIVES: Treatment with solvent-detergent is widely used for ensuring the virus safety of plasma products. Laboratory studies have shown this procedure to be effective for inactivating enveloped viruses under manufacturing conditions. In the present study, the effect of different manufacturing process parameters on virus inactivation by treatment with polysorbate 80 and tri-n-butyl phosphate were investigated for a high-purity factor IX concentrate in order to evaluate the robustness of this step. MATERIALS AND METHODS: Samples of factor IX intermediate were obtained, virus was added and the kinetics of virus inactivation followed during incubation. The effect of altering the conditions on virus inactivation was tested. RESULTS: Solvent-detergent treatment was confirmed to effectively inactivate, i.e. by > or = 5 log, a wide range of representative enveloped viruses under standard conditions. Virus inactivation was consistently effective in a number of different manufacturing batches. Of the parameters tested, only solvent-detergent concentration and temperature significantly effected virus inactivation. CONCLUSIONS: The robustness of the solvent-detergent step for virus inactivation has been confirmed. Using the data generated, appropriate limits can be set for this manufacturing process step.

Using quality of life scores to help determine treatment: is restoring bowel continuity better than an ostomy?

OBJECTIVE: In colorectal surgery, evaluation of heath-related quality of life (HRQL) has been relatively minimal when compared to other medical specialties. Would the performance of such HRQL evaluations change our decision-making in patient care? In familial adenomatous polyposis (FAP), procedures that restore bowel continuity (i.e. Ileorectal anastomosis or ileal pouch anal anastomosis) are routinely preferred to ileostomy because of the perceived, but unproven, better HRQL. This study evaluates FAP patients who underwent prophylactic colectomy with either permanent ileostomy or 'restored bowel continuity' reconstruction. The functional outcomes of both groups are reported, and the HRQL assessments are compared. METHODS: All FAP patients who underwent (procto) colectomy resection with reconstruction, either restored bowel continuity (BC) or permanent ileostomy (OST), between 1980 and 1998 were studied. Functional data were obtained by questionnaire and medical record review. HRQL was assessed by 2 validated instruments - the SF-36 Physical and Mental Health Summary Scales and the SF-36 Health Survey - which measure physical summary (PSF) and mental summary functioning (MSF) as well as eight separate health quality dimensions including health perception (HP), physical (PF) and social functioning (SF), physical (PR) and emotional role limitations (ER), mental health (MH), bodily pain (BP), and energy level (E). RESULTS: Results were obtained in 54 patients; bowel continuity (44), ileostomy (10). Mean patient age was 39 years, mean follow up time was 10.5 years. Mean patient age at operation was 28 years. Functional results for BC included number of bowel movements/day (6.7), leakage (30%), having to wear a pad (11%), perianal skin problems (25%), food avoidance (68%), and inability to distinguish gas (27%). Functional results for OST were routinely excellent. Results of the HRQL surveys reveal no significant differences for BC vs OST (HP: 67 +/- 28 vs 79 +/- 39; PF: 91 +/- 14 vs 90 +/- 17; SF: 86 +/- 23 vs 97 +/- 5; PR: 79 +/- 34 vs 83 +/- 40; ER: 86 +/- 28 vs 88 +/- 27; MH: 77 +/- 19 vs 82 +/- 14; BP: 78 +/- 24 vs 71 +/- 32; E 60 +/- 21 vs 58 +/- 18, respectively). CONCLUSION: Although the perceived quality of life for ileostomy patients is generally worse than the 'restored bowel continuity' group, the measured HRQL is the same for both groups. These results suggest that a permanent ileostomy should be included as a viable and appropriate first line treatment option for FAP patients after resection. This study also suggests that HRQL should play a greater role in the evaluation of care and treatment in colorectal surgery.

Patient-initiated treatment of uncomplicated recurrent urinary tract infections in young women.

BACKGROUND: Recurrent urinary tract infections (UTIs) are a common outpatient problem, resulting in frequent office visits and often requiring the use of prophylactic antimicrobial agents. Patient-initiated treatment of recurrent UTIs may decrease antimicrobial use and improve patient convenience. OBJECTIVE: To determine the safety and feasibility of patient-initiated treatment of recurrent UTIs. DESIGN: Uncontrolled, prospective clinical trial. SETTING: University-based primary health care clinic. PARTICIPANTS: Women at least 18 years of age with a history of recurrent UTIs and no recent pregnancy, hypertension, diabetes, or renal disease. INTERVENTION: After self-diagnosing UTI on the basis of symptoms, participating women initiated therapy with ofloxacin or levofloxacin. MEASUREMENTS: Accuracy of self-diagnosis determined by evidence of a definite (culture-positive) or probable (sterile pyuria and no alternative diagnosis) UTI on pretherapy urinalysis and culture. Women with a self-diagnosis of UTI that was not microbiologically confirmed were evaluated for alternative diagnoses. Post-therapy interviews and urine cultures were used to assess clinical and microbiological cure rates, adverse events, and patient satisfaction. RESULTS: 88 of 172 women self-diagnosed a total of 172 UTIs. Laboratory evaluation showed a uropathogen in 144 cases (84%), sterile pyuria in 19 cases (11%), and no pyuria or bacteriuria in 9 cases (5%). Clinical and microbiological cures occurred in 92% and 96%, respectively, of culture-confirmed episodes. No serious adverse events occurred. CONCLUSION: Adherent women can accurately self-diagnose and self-treat recurrent UTIs.

Long-term outcomes of the ileal pouch anal anastomosis: the association of bowel function and quality of life 5 years after surgery.

INTRODUCTION: Previous studies have reported that mean health related quality of life (HRQL) levels generally attain normalcy following construction of an ileal pouch anal anastomosis (IPAA). It appears inconsistent, however, that these normal HRQL levels are achieved while bowel function (BF) scores generally remain statistically worse than "normal" (e.g., 4-8 stools/day, possible anal leakage, diaper usage). To investigate this inconsistency, the current study attempts to determine if any statistical associations are present between HRQL and BF, specifically in the long term. Multivariate regression analyses are performed using each of 8 individual HRQL domains against the full model of BF characteristics. METHODS: All patients more than 5 years status post an ileal pouch anal anastomosis (IPAA) procedure for familial adenomatous polyposis (FAP) at a single institution were studied. FAP was chosen because patients are routinely asymptomatic preoperatively. BF (e.g., stool frequency, anal leakage) and HRQL (using the 8 health domains of the SF-36) were assessed by patient interview. Student's t tests and full model multivariate regression analyses were used to analyze associations between BF and HRQL. RESULTS: The sample included 25 patients (14 male). Mean age was 39 years, mean follow-up time was 11 years. Although mean scores for the 8 individual HRQL domains were not statistically different from the general United States population, regression analyses of the different domains did demonstrate significant associations with varying levels of BF. While controlling for age and gender, the analyses show that the physical function domain is improved with the ability to pass flatus independent of stool, and physical role and mental health domains are improved with decreased stool frequency. The social function domain is improved with increased stool retention time, while the perception of general health is improved with less diaper usage and less sexual dysfunction. CONCLUSIONS: This study shows that a statistically significant association between HRQL levels and BF is present. Of the numerous BF characteristics tested, five appear to be of greater importance with regard to certain HRQL domains. This finding may have clinical implications concerning pouch construction and surgical technique. Methodologically, this study demonstrates that merely using mean levels to describe HRQL may not elucidate meaningful relationships between important clinical outcomes, such as function and HRQL.

A prospective study of asymptomatic bacteriuria in sexually active young women.

BACKGROUND: Asymptomatic bacteriuria is common in young women, but little is known about its pathogenesis, natural history, risk factors, and temporal association with symptomatic urinary tract infection. METHODS: We prospectively evaluated 796 sexually active, nonpregnant women from 18 through 40 years of age over a period of six months for the occurrence of asymptomatic bacteriuria (defined as at least 10(5) colony-forming units of urinary tract pathogens per milliliter). The women were patients at either a university student health center or a health maintenance organization. Periodic urine cultures were taken, daily diaries were kept, and regularly scheduled interviews were performed. Escherichia coli strains were tested for hemolysin, the papG genotype, and the ribosomal RNA type. RESULTS: The prevalence of asymptomatic bacteriuria (the proportion of urine cultures with bacteriuria in asymptomatic women) was 5 percent (95 percent confidence interval, 4 percent to 6 percent) among women in the university group and 6 percent (95 percent confidence interval, 5 percent to 8 percent) among women in the health-maintenance-organization group. Persistent asymptomatic bacteriuria with the same E. coli strain was rare. Symptomatic urinary tract infection developed within one week after 8 percent of occasions on which a culture showed asymptomatic bacteriuria, as compared with 1 percent of occasions when asymptomatic bacteriuria was not found (P<0.001). Asymptomatic bacteriuria was associated with the same risk factors as for symptomatic urinary tract infection, particularly the use of a diaphragm plus spermicide and sexual intercourse. CONCLUSIONS: Asymptomatic bacteriuria in young women is common but rarely persists. It is a strong predictor of subsequent symptomatic urinary tract infection.

Risk factors for recurrent urinary tract infection in young women.

To define host factors associated with an increased risk of recurrent urinary tract infection (RUTI), a case-control study was conducted in 2 populations: university women and health maintenance organization enrollees. Case patients were 229 women 18-30 years old with RUTIs; control subjects were 253 randomly selected women with no RUTI history. In a multivariate model, independent risk factors for RUTI included recent 1-month intercourse frequency (odds ratio [OR], 5.8; 95% confidence interval [CI], 3.1-10.6 for 4-8 episodes), 12-month spermicide use (OR, 1.8; 95% CI, 1.1-2.9), and new sex partner during the past year (OR, 1.9; 95% CI, 1.2-3.2). Two newly identified risk factors were age at first urinary tract infection (UTI)

Comparison of the inactivation of canine and bovine parvovirus by freeze-drying and dry-heat treatment in two high purity factor VIII concentrates.

The inactivation of bovine parvovirus (BPV) and canine parvovirus (CPV) by freeze-drying and terminal dry-heat treatment at 80 degrees C for 72 h has been investigated in two high purity factor VIII concentrates. In one product, CPV was slightly more resistant to freeze-drying compared to BPV, i.e. 0.7 vs. 1.4 log. However, BPV was substantially more resistant to heat-treatment compared to CPV, i.e. 1.3 vs. > 3.1 log inactivation after 72 h at 80 degrees C. In a second product, CPV was also slightly more resistant to freeze-drying than BPV, i.e. 0.2 vs. 1.3 log inactivation. However, heat-treatment gave essentially similar inactivation for both viruses, i.e. 2.8-3.4 log after 72 h at 80 degrees C. In conclusion, the resistance of these parvovirus models is dependent both on the type of virus and on the specific product involved.

Does better functional result equate with better quality of life? Implications for surgical treatment in familial adenomatous polyposis.

PURPOSE: The main impetus for a patient with familial adenomatous polyposis to choose colectomy with ileorectal anastomosis over ileal pouch-anal anastomosis is the better functional result. However, does better functional result necessarily translate into better overall quality of life? Previous studies of other diseases have demonstrated no such correlation. This study was performed to determine whether any relationship exists between functional result and quality of life in patients with familial adenomatous polyposis after ileorectal anastomosis and ileal pouch-anal anastomosis. METHODS: All patients with familial adenomatous polyposis who underwent colectomy with ileorectal anastomosis or proctocolectomy with ileal pouch-anal anastomosis from 1980 to 1998 were studied. Functional data were obtained by questionnaire. Health-related quality of life was assessed by two validated instruments, the SF-36 Physical and Mental Health Summary Scales and the SF-36 Health Survey, which measure physical and mental functioning and eight separate health-quality dimensions, including health perception, physical and social functioning, physical and emotional role limitations, mental health, bodily pain, and energy or fatigue. RESULTS: Data were obtained in 44 of 68 patients, 14 with ileorectal anastomosis and 30 with ileal pouch-anal anastomosis. No differences were demonstrated between the two groups for patient age, mean follow-up time, and mean patient age at operation. Functional results were worse for the ileal pouch-anal anastomosis group vs. the ileorectal anastomosis group in number of bowel movements per day (7.5 vs. 5.2; P < 0.05), leakage (43 vs. 0 percent; P < 0.01), pad usage (17 vs. 0 percent; P < 0.01), perianal skin problems (33 vs. 7 percent; P < 0.01), food avoidance (80 vs. 43 percent; P < 0.01), and inability to distinguish gas (37 vs. 7 percent; P < 0.01). Results of the health-related quality-of-life surveys, however, demonstrated no difference between the ileal pouch-anal anastomosis and ileorectal anastomosis groups. The Physical and Mental summary scales for the ileal pouch-anal anastomosis and ileorectal anastomosis groups were not significantly different (Physical Health Scale, 50.3 vs. 50.9; Mental Health Scale, 51.7 vs. 49.6), and none of the eight dimensions of the SF-36 health survey demonstrated statistical differences between the ileal pouch-anal anastomosis and ileorectal anastomosis groups. CONCLUSION: Better functional results were not equated with better quality of life in this pilot study. Although patients with the ileorectal anastomosis have better functional results than those with ileal pouch-anal anastomosis, the measured health-related quality of life as determined by a validated generic health-related quality-of-life instrument is the same for both groups. These results suggest that all patients with familial adenomatous polyposis might be optimally treated with an ileal pouch-anal anastomosis. More importantly, this study suggests that health-related quality of life should play a greater role in the evaluation of care and treatment in colon rectal surgery.

Effects of contraceptive method on the vaginal microbial flora: a prospective evaluation.

A prospective evaluation of 331 university women who were initiating use of oral contraceptive pills (OCPs), a cervical cap, diaphragm-spermicide, or other spermicidal methods was done to assess the effects of commonly used contraceptive methods on the vaginal flora. Vaginal introital cultures were performed at baseline and then weekly for 1 month. The prevalence of Escherichia coli vaginal colonization and of abnormal vaginal Gram stain scores (Nugent criteria) increased significantly among women using a cervical cap or diaphragm-spermicide but not among women using OCPs. Women with E. coli colonization were significantly more likely to have an abnormal Nugent score and an absence of lactobacilli. In a multivariate model, use of spermicidal contraception in the preceding week was associated with an abnormal Nugent score and with colonization with E. coli, Enterococcus species, and anaerobic gram-negative rods. Thus, spermicidal methods of contraception are associated with alterations of the vaginal microflora that consequently may predispose women to genitourinary infections.