Prophylactic antibiotics for miscarriage surgery: A protocol for systematic review and meta-analysis.

BACKGROUND: Infection is a serious potential consequence of surgery to complete a spontaneous abortion. Antibiotic prophylaxis before some operations has been shown to reduce the risk of postoperative infections. However, for miscarriage surgery, evidence is lacking to show effectiveness. METHODS: In this systematic review, the electronic databases of Cochrane Central Register of Controlled Trials, EMBASE, and PUBMED will be searched from inception to May 1, 2020. Randomized controlled trials that assessed the effectiveness and safety of antibiotic prophylaxis for preventing infection for patients undergoing miscarriage surgery will be included. All process of the study selection, data extraction, and methodology evaluation will be carried out by two authors independently. RevMan 5.3 software will be utilized for statistical analysis. RESULTS: This study will provide a detailed summary of latest evidence related to the effectiveness and safety of antibiotic prophylaxis for preventing infection for patients undergoing miscarriage surgery. CONCLUSION: The findings of this study may provide possible guidance for the use of antibiotic prophylaxis for preventing infection for patients undergoing miscarriage surgery. DISSEMINATION AND ETHICS: Ethical approval is not required in this study, because it will not collect the original data from individual patient. The results are expected to publish through a peer-reviewed journal. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD CRD42020155643.

Analysis of Ornidazole Injection in Clinical Use at Post-marketing Stage by Centralized Hospital Monitoring System.

This study aims to analyze the clinical use of ornidazole injection at the post-marketing stage by centralized hospital monitoring system method, and investigate its widespread use in patients, in order to regulate and guide the rational drug use, improve the drug specificity and provide a basis for drug therapy. The study adopts a prospective, multi-center, large sample size, centralized hospital monitoring system. We selected five leading hospitals in Hubei province, and observed the inpatients who received the ornidazole injection from July 1, 2015 to October 31, 2015. The basic information of patients was recorded, as well as the drug use and adverse events. The statistical analysis was performed based on these data. A total of 4396 individuals were enrolled in this study, most of them were middle-aged female patients and the ornidazole injection was mainly used as prophylactic prior to surgery to prevent the infections, and surgical treatment of anaerobic infections, abdominal infections and pelvic infections. The irrational drug use existed mainly in the prescribing and administration process, including unreasonable dosing frequency, rapid intravenous drip speed and extended duration of drug use. Eleven cases of adverse reactions were collected during the monitoring, incidence rate of adverse reactions was 2.5‰; adverse drug reactions occurred within 30 min. The study results fully reflected the usage of ornidazole injection in the real world. Based on the study, we calculated the adverse reaction incidence of ornidazole and identified the risk factors which may affect the safety of ornidazole injection. Study results strongly recommend that the manufacturers should publish standards for inpatient use and doctors should prescribe with caution accordingly.

A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.

BACKGROUND: Surgical intervention is needed in some cases of spontaneous abortion to remove retained products of conception. Antibiotic prophylaxis may reduce the risk of pelvic infection, which is an important complication of this surgery, particularly in low-resource countries. METHODS: We conducted a double-blind, placebo-controlled, randomized trial investigating whether antibiotic prophylaxis before surgery to complete a spontaneous abortion would reduce pelvic infection among women and adolescents in low-resource countries. We randomly assigned patients to a single preoperative dose of 400 mg of oral doxycycline and 400 mg of oral metronidazole or identical placebos. The primary outcome was pelvic infection within 14 days after surgery. Pelvic infection was defined by the presence of two or more of four clinical features (purulent vaginal discharge, pyrexia, uterine tenderness, and leukocytosis) or by the presence of one of these features and the clinically identified need to administer antibiotics. The definition of pelvic infection was changed before the unblinding of the data; the original strict definition was two or more of the clinical features, without reference to the administration of antibiotics. RESULTS: We enrolled 3412 patients in Malawi, Pakistan, Tanzania, and Uganda. A total of 1705 patients were assigned to receive antibiotics and 1707 to receive placebo. The risk of pelvic infection was 4.1% (68 of 1676 pregnancies) in the antibiotics group and 5.3% (90 of 1684 pregnancies) in the placebo group (risk ratio, 0.77; 95% confidence interval [CI], 0.56 to 1.04; P = 0.09). Pelvic infection according to original strict criteria was diagnosed in 1.5% (26 of 1700 pregnancies) and 2.6% (44 of 1704 pregnancies), respectively (risk ratio, 0.60; 95% CI, 0.37 to 0.96). There were no significant between-group differences in adverse events. CONCLUSIONS: Antibiotic prophylaxis before miscarriage surgery did not result in a significantly lower risk of pelvic infection, as defined by pragmatic broad criteria, than placebo. (Funded by the Medical Research Council and others; AIMS Current Controlled Trials number, ISRCTN97143849.).

Prophylactic antibiotics to reduce pelvic infection in women having miscarriage surgery - The AIMS (Antibiotics in Miscarriage Surgery) trial: study protocol for a randomized controlled trial.

BACKGROUND: The estimated annual global burden of miscarriage is 33 million out of 210 million pregnancies. Many women undergoing miscarriage have surgery to remove pregnancy tissues, resulting in miscarriage surgery being one of the most common operations performed in hospitals in low-income countries. Infection is a serious consequence and can result in serious illness and death. In low-income settings, the infection rate following miscarriage surgery has been reported to be high. Good quality evidence on the use of prophylactic antibiotics for surgical miscarriage management is not available. Given that miscarriage surgery is common, and infective complications are frequent and serious, prophylactic antibiotics may offer a simple and affordable intervention to improve outcomes. METHODS: Eligible patients will be approached once the diagnosis of miscarriage has been made according to local practice. Once informed consent has been given, participants will be randomly allocated using a secure internet facility (1:1 ratio) to a single dose of oral doxycycline (400 mg) and metronidazole (400 mg) or placebo. Allocation will be concealed to both the patient and the healthcare providers. A total of 3400 women will be randomised, 1700 in each arm. The medication will be given approximately 2 hours before surgery, which will be provided according to local practice. The primary outcome is pelvic infection 2 weeks after surgery. Women will be invited to the hospital for a clinical assessment at 2 weeks. Secondary outcomes include overall antibiotic use, individual components of the primary outcome, death, hospital admission, unplanned consultations, blood transfusion, vomiting, diarrhoea, adverse events, anaphylaxis and allergy, duration of clinical symptoms, and days before return to usual activities. An economic evaluation will be performed to determine if prophylactic antibiotics are cost-effective. DISCUSSION: This trial will assess whether a single dose of doxycycline (400 mg) and metronidazole (400 mg) taken orally 2 hours before miscarriage surgery can reduce the incidence of pelvic infection in women up to 2 weeks after miscarriage surgery. TRIAL REGISTRATION: Registered with the ISRCTN (international standard randomised controlled trial number) registry: ISRCTN 97143849 . (Registered on April 17, 2013).

Sobre drenar o no drenar la anastomosis infraperitoneal tras escisión rectal por cáncer / To drain or not to drain the infraperitoneal anastomosis after rectal excision for cancer

No disponible

Preoperative Vaginal Metronidazole Decreases the Risk of Pelvic Infections After Radical Robotic Hysterectomy.

OBJECTIVES: Risk factors and infection rates of radical robotic procedures have yet to be described in gynecology. A practice improvement strategy using a solitary dose of vaginal metronidazole the night before surgery was initiated to determine if it decreased the risk of pelvic infection. METHODS: A retrospective chart review of robotic radical hysterectomies for gynecologic malignancy at our institution from April 2010 through April 2016 was performed. Demographic data, operative data, and data on use of metronidazole before surgery were collected. χ Statistical analysis, Student t test, and multivariate analysis were performed to analyze the data. RESULTS: Ninety-four patients met the inclusion criteria, and 46 patients received vaginal metronidazole. Demographic and clinical factors were similar between the 2 groups. The pelvic infection rate was significantly higher in nonusers at 13% (6/46) compared with users at 0% (0/42) (P ≤ 0.05). The genitourinary infection rate was also significantly higher in nonusers at 20% as compared with users at 2.2% (P = 0.02). Operative risk factors found to be associated with pelvic infection included hospital length of stay, blood loss, and metronidazole use. Multivariate regression analysis determined that only vaginal metronidazole had a clinically significant reduction of pelvic and genitourinary infection. DISCUSSION: A single dose of preoperative vaginal metronidazole reduces the risk of pelvic and genitourinary infection after robotic radical hysterectomy.

Influence of Gelatin-Thrombin Matrix Tissue Sealant on Bacterial Colony Formation and Risk of Pelvic Infection.

Objective. Gelatin-thrombin matrix (GTM) tissue sealant use was previously identified as an independent predictor of pelvic infection following hysterectomies. We aim to elucidate contributing factors by assessing influence of GTM on bacterial colony formation and characterizing bacteria present at the vaginal cuff. Methods. Escherichia coli was incubated in phosphate-buffered saline (PBS) and pelvic washings with and without GTM to assess influence on colony formation. Pelvic washings of the vaginal cuff were collected from hysterectomies occurring from June through October 2015. In vitro techniques, 16S rRNA gene qPCR, and 16S amplicon sequencing were performed with washings to characterize bacteria at the vaginal cuff. Results. Mean bacterial colony formation in PBS was greater for E. coli incubated in the presence of GTM (1.48 × 10(7) CFU/mL) versus without (9.95 × 10(5) CFU/mL) following 20-hour incubation (p = 0.001). Out of 61 pelvic washings samples, 3 were culture positive (≥5000 CFU/mL) with Enterococcus faecalis. Conclusion. In vitro experiments support a facilitating role of GTM on colony formation of E. coli in PBS. However, given the negative results of surgical site washings following adequate disinfection, the role of GTM in promoting posthysterectomy pelvic infections may be limited. Analysis of pelvic washings revealed presence of E. faecalis, but results were inconclusive. Further studies are recommended.

Omental flap after pelvic exenteration for pelvic cancer.

Pelvic infection is a significant clinical problem after pelvic exenteration. The clinical benefit of an omental flap in reducing the incidence of such infections is unknown. The aim of this study was to evaluate whether an omental flap after pelvic exenteration reduces the incidence of pelvic infection and the length of postoperative hospital stay. In this study, we demonstrate a safe, effective, simple method for reducing the incidence of pelvic infection using an omental flap. We performed pelvic exenteration for tumors that were suspected to have extensive invasion to the bladder, prostate, or uterus. The omentum was dissected from the transverse colon and greater curvature of the stomach. The flap was based on the right gastroepiploic vessels and tunneled in the retrocolic plane, through the mesentery of the transverse colon and ileocecum, to the defect. Twenty-seven patients were analyzed retrospectively. Ten patients received omental flaps, and 17 patients underwent pelvic exenteration without an omental flap. The incidence of pelvic infection was significantly reduced in the patients with omental flaps.

Role of drains in laparoscopic appendectomy for complicated appendicitis at a busy county hospital.

Laparoscopic appendectomy (LA) has become the treatment of choice for acute appendicitis with equal or better outcomes than traditional open appendectomy (OA). LA in patients with a gangrenous or perforated appendicitis carries increased rate of pelvic abscess formation when compared with OA. We hypothesized routine placement of pelvic drains in gangrenous or perforated appendicitis decreases pelvic abscess formation after LA. Three hundred thirty-one patients undergoing LA between January 2007 and June 2011 were reviewed. Patients with perforated or gangrenous appendicitis were included. Group I had a Jackson-Pratt (JP) drain(s) placed and Group II had no JP drain. Data included patient demographics, emergency department laboratory values and vital signs, and computed axial tomography scan findings, intra-abdominal or pelvic abscess postoperatively, interventional radiology drainage, and length of stay. Clinic follow-up notes were reviewed. One hundred forty-eight patients were identified. Forty-three patients had placement of JP drains (Group I) and 105 patients had no JP drain (Group II). Three patients (three of 43 [6%]) in Group I developed pelvic abscess and 21 of 105 (20%) patients in Group II developed pelvic abscesses requiring subsequent drainage. This was statistically significant. Patient demographics, temperature, and mean white blood count before surgery were similar. Presurgery computed tomography (CT) with appendicolith and CT with abscess were more prevalent in Group I. The use of JP drainage in patients with perforated or gangrenous appendicitis during LA has decreased rates of pelvic abscess. This was demonstrated despite the drain group having appendicolith or abscess on preoperative CT.

Incidence of uterine post abortion infection at Hospital de Clínicas de Porto Alegre. Is prophylactic antibiotic necessary?

OBJECTIVE: To identify the incidence of pelvic infection after miscarriage undergoing uterine evacuation in a tertiary hospital in southern Brazil and to compare with the international literature. METHODS: we reviewed electronic medical records of the Hospital de Clinicas de Porto Alegre of all patients who underwent uterine evacuation for miscarriage between August 2008 and January 2012 were reviewed. We included all patients submitted to uterine curettage due to abortion and who had outpatient visits for review after the procedure. We calculated emographic and laboratory data of the study population, number needed for treatment (NNT) and number needed to harm (NNH). RESULTS: of the 857 revised electronic medical records, 377 patients were subjected to uterine evacuation for miscarriage; 55 cases were lost to follow-up, leaving 322 cases that were classified as not infected abortion on admission. The majority of the population was white (79%); HIV prevalence and positive VDRL was 0.3% and 2%, respectively. By following these 322 cases for a minimum of seven days, it was found that the incidence of post-procedure infection was 1.8% (95% CI 0.8 to 4). The NNT and NNH calculated for 42 months were 63 and 39, respectively. CONCLUSION: The incidence of post-abortion infection between August 2008 to January 2012 was 1.8% (0.8 to 4).

Incidence of uterine post abortion infection at Hospital de Clínicas de Porto Alegre. Is prophylactic antibiotic necessary? / Incidência de infecção pós-abortamento no Hospital de Clínicas de Porto Alegre. O antibiótico profilático é necessário?

OBJECTIVE: To identify the incidence of pelvic infection after miscarriage undergoing uterine evacuation in a tertiary hospital in southern Brazil and to compare with the international literature. METHODS: we reviewed electronic medical records of the Hospital de Clinicas de Porto Alegre of all patients who underwent uterine evacuation for miscarriage between August 2008 and January 2012 were reviewed. We included all patients submitted to uterine curettage due to abortion and who had outpatient visits for review after the procedure. We calculated emographic and laboratory data of the study population, number needed for treatment (NNT) and number needed to harm (NNH). RESULTS: of the 857 revised electronic medical records, 377 patients were subjected to uterine evacuation for miscarriage; 55 cases were lost to follow-up, leaving 322 cases that were classified as not infected abortion on admission. The majority of the population was white (79%); HIV prevalence and positive VDRL was 0.3% and 2%, respectively. By following these 322 cases for a minimum of seven days, it was found that the incidence of post-procedure infection was 1.8% (95% CI 0.8 to 4). The NNT and NNH calculated for 42 months were 63 and 39, respectively. CONCLUSION: The incidence of post-abortion infection between August 2008 to January 2012 was 1.8% (0.8 to 4). .

OBJETIVO: Identificar a incidência de infecção pélvica após aborto espontâneo submetido a esvaziamento uterino num hospital terciário do sul do Brasil e comparar com a literatura internacional. MÉTODOS: Os prontuários eletrônicos do Hospital de Clínicas de Porto Alegre de todas as pacientes que foram submetidas ao esvaziamento uterino por abortamento entre agosto de 2008 e Janeiro de 2012 foram revisados. Foram incluídas no estudo todas as pacientes submetidas à curetagem uterina por abortamento e que tiveram consultas ambulatoriais de revisão após o procedimento. Os dados demográficos e laboratoriais da população estudada, number needed for treatment (NNT) e o number needed to harm (NNH) foram calculados. RESULTADOS: Dos 857 prontuários eletrônicos revistos, 377 pacientes foram submetidas ao esvaziamento uterino por abortamento; 55 casos foram perdidos no seguimento, restando 322 casos que foram classificados como aborto não infectado na admissão. A maioria da população era da raça branca (79%); a prevalência de HIV e VDRL positivos foi de 0,3 e 2%, respectivamente. No seguimento desses 322 casos, num período mínimo de 7 dias, verificou-se que a incidência de infecção pós-procedimento foi de 1,8% (IC95%0,8 a 4). O NNT e o NNH calculado para 42 meses foi de 63 e 39, respectivamente. CONCLUSÃO: A incidência de infecção pós-aborto entre agosto de 2008 a janeiro de 2012 foi de 1,8% (0,8 a 4). .

Postplacental intrauterine device insertion at a teaching hospital.

OBJECTIVE: To determine whether postplacental intrauterine device (IUD) insertion can be safely and effectively performed within a teaching program. STUDY DESIGN: This was a prospective cohort of 177 subjects planning vaginal delivery enrolled antenatally who desired postplacental IUD insertion of either the copper T380A IUD or levonorgestrel IUS. Insertions were performed primarily by resident physicians following a training session. Follow-up included a 4- to 8-week visit and telephone calls at 3 and 6 months. RESULTS: Ninety-nine subjects underwent successful postplacental IUD insertion of 100 attempts. Seventeen expulsions (17%) were noted: 10 complete and 7 partial. The study identified no differences in outcome by training level; however, the study lacked statistical power to evaluate anything other than large differences. CONCLUSION: Postplacental IUD insertions can be safely and effectively performed within a training program. IMPLICATIONS: A training protocol may safely and feasibly be initiated among physicians, advanced practice clinicians or trainees with no prior experience with postplacental IUD insertion. By initiating this practice, access to highly effective contraception may increase for patients who have difficulty returning for a visit or otherwise receiving effective methods.

Where do sexually active female London students go to access healthcare? Evidence from the POPI (Prevention of Pelvic Infection) chlamydia screening trial.

BACKGROUND: Little is known about where sexually active female students access healthcare. OBJECTIVES: Using data from the Prevention of Pelvic Infection (POPI) cohort, the authors aimed to: Describe where sexually active female students aged ≤ 27 years reported accessing healthcare. Investigate the association between numbers of sexual partners during 12 months of follow-up and healthcare usage, health-related quality of life (EQ-5D) and demographic and behavioural characteristics. METHODS: Participants provided vaginal swabs and completed questionnaires on sexual health and quality of life at baseline and at a 12-month follow-up. The follow-up questionnaire also asked about healthcare attendances during the previous 12 months. Mann-Whitney tests were used to relate healthcare seeking behaviour and other characteristics to reported numbers of partners during follow-up. RESULTS: Of 1865 women included in the analysis, 79% paid at least one visit to their general practice during follow-up, 23% attended an accident and emergency/walk-in clinic, 21% a family planning clinic and 14% a genitourinary medicine clinic. As the number of sexual partners increased (0-1, 2-3, 4+), women were more likely to have visited a genitourinary medicine clinic (10%, 16%, 30%, p<0.001) or accident and emergency/walk-in clinic (21%, 26%, 29%, p<0.002). Women with more sexual partners were also more likely to smoke, use condoms, be aged <16 years at sexual debut, have bacterial vaginosis, chlamydia or gonorrhoea at baseline and to have lower EQ5-D scores. CONCLUSION: This is the first UK study of healthcare attendance in multiethnic female students recruited outside healthcare settings. The high attendance in general practice may represent a valuable opportunity for screening for sexually transmitted infections.

Conservative management of ventriculoperitoneal shunts in the setting of abdominal and pelvic infections.

OBJECT: The optimal management of a ventriculoperitoneal shunt in the setting of acute, non-shunt related abdominal and pelvic infections is unknown. In the literature, distal shunt catheter reimplantation with or without a variable period of externalization has been recommended to prevent ascending ventriculitis. While this strategy is effective, there is little to almost no published data suggesting that it is necessary in all cases. Furthermore, it is not clear that shunt externalization to an external drainage bag during the treatment of non-shunt related peritonitis is any less likely to lead to ventriculitis than leaving the catheter in place. In the authors' experience, shunt externalization or revision during an episode of acute, non-shunt related peritonitis is unnecessary to prevent ventriculitis or chronic peritonitis. METHODS: In the present case series, the authors report on 7 patients whose shunts were left in the abdomen while they were treated for acute peritonitis. The patients were followed clinically for up to 21 months after the diagnosis to assess for evidence of recurrent abdominal infections, shunt infections, or shunt failure. RESULTS: In a follow-up period ranging from 13 to 22 months, no patient developed ventriculitis, required a shunt revision, or was unable to clear the peritoneal infection. CONCLUSIONS: The results of this small series suggest that leaving the distal end of a shunt catheter in place in a patient with acute peritonitis is a reasonably safe choice in specific patients, provided the source of infection is aggressively treated with systemic antibiotics and local debridement when necessary.

Early, minimally invasive closure of anastomotic leaks: a new concept.

Chronic pelvic sepsis after ileoanal or coloanal anastomosis precludes ileostomy closure and, even if closure is ultimately possible, function of the neorectum is badly affected. Early closure of the anastomotic leak might prevent chronic pelvic sepsis and its adverse sequelae. In our experience of early closure in a consecutive group of six patients with a leaking low anastomosis (five with ileoanal pouch anastomosis and one after a low anterior resection), we were able to achieve anastomotic closure in five by means of initial endosponge therapy followed either by early suture (four patients) or endoscopic clip repair (one patient). Early minimally invasive closure of low anastomotic leaks is therefore possible provided that the para-anastomotic cavity is drained well prior to closure and the anastomosis is defunctioned.

Urogenital pathogen inhibition and compatibility between vaginal Lactobacillus strains to be considered as probiotic candidates.

OBJECTIVES: To evaluate the production of inhibitory substances against several urogenital pathogens and to determine the compatibility between selected vaginal lactobacilli to be considered as probiotic candidates. STUDY DESIGN: The inhibitory activity of 38 vaginal Lactobacillus strains against urogenital pathogens was assessed using the agar plate diffusion. METHOD: The production of hydrogen peroxide was determined by the semi-qualitative tetramethyl-benzidine-peroxidase assay and that of lactic acid by high performance liquid chromatography. Pre-selected lactobacilli were genetically identified by ribosomal 16S-DNA sequencing and used to determine the compatibility of strains. Correlation values between some inhibitory properties were calculated. RESULTS: 45% of the lactobacilli assayed inhibited the growth of various urogenital pathogens, except Candida albicans, mainly by the effect of organic acids. Even though 71% of the Lactobacillus strains produced hydrogen peroxide in the semi-qualitative test, the antimicrobial effect of the oxidative metabolite on pathogens was not detected under the experimental conditions assayed. On the other hand, the inhibition spectrum of salivaricin CRL 1328 was widened with respect to the one previously reported by our research team. With respect to the degree of interaction between the pre-selected lactobacilli, most of them showed inhibition of at least one strain, mainly due to the effects of both organic acids and hydrogen peroxide. CONCLUSION: Several lactobacilli that showed inhibitory activity against urogenital pathogens or produced hydrogen peroxide are compatible between them. Therefore, different potential combinations of strains are proposed for their inclusion in the design of probiotic products to be vaginally administered for the prevention of urogenital infections in women.

Should all oocyte donors receive prophylactic antibiotics for retrieval?

In a retrospective study comparing 526 oocyte donors who received prophylactic antibiotics for oocyte retrieval with a comparable group of 625 who did not, the incidence of infection after retrieval was reduced from 0.4% to 0 in the group receiving antibiotics. Donors take risks but have no medical indication for the procedures that they undergo; our data suggest that prophylactic antibiotics at retrieval should be considered to minimize the risk of infection.

Expectant management of first-trimester miscarriage.

Miscarriage is the most common complication of pregnancy, which creates a significant workload for health-care professionals. For decades, surgical evacuation of the uterus has remained the conventional treatment of first-trimester miscarriage. Recently, non surgical treatments have been introduced with increasing popularity. This review explores the evidence in support of expectant management of first-trimester miscarriage. It is safe, effective and well-tolerated by women. It enhances women's choice and control. It generates significant cost savings compared with the traditional surgical management. Accurate diagnosis, counselling, 24/7 telephone advice and follow-up are among the important aspects of expectant management. More studies are needed to develop methods for identifying miscarriages suitable for expectant management.

Prevention of severe pelvic abscess formation following extended radical surgery for locally recurrent rectal cancer.

BACKGROUND: For treatment of locally recurrent rectal cancer (LRRC), extended radical surgery is sometimes required to obtain a negative margin. Such surgery is often associated with severe postoperative pelvic abscess (PA) formation. The aim of this study was to determine the effects of reconstructive surgery using a large rectus abdominis myocutaneous (RAM) flap and anal preservation surgery on the incidence of severe PA. METHOD: Between February 1998 and June 2008, 44 patients underwent extended surgery for LRRC. Patients were divided into the pre-2004 group (n = 15) and the post-2004 group (n = 29). To reduce the risk of infections, we modified the surgical approach after 2004 to include a larger volume of RAM flap (modified RAM flap) and implemented anal preservation surgery. RESULTS: The overall incidence of severe PA was significantly lower in the post-2004 group [6 of 29 (21%)] than the pre-2004 group [9 of 15 (60%), P = 0.017]. The incidence of severe PA was lower in the anal preservation group [1 of 12 (8.3%)] compared with those who did not undergo such surgery [14 of 32 (44%), P = 0.035]. Modified RAM flap reduced the incidence of severe PA, albeit insignificantly (pre-2004 group: 57%, post-2004 group: 23%). All three patients who underwent anal preservation and modified RAM flap reconstruction did not develop severe PA. Multiple logistic analysis identified no anal preservation (Odds ratio [OR] = 10.6) and performing of sacrectomy (OR = 20.0) as risk factors for severe PA. CONCLUSION: Anal preservation surgery is an effective measure against the development of severe PA after radical resection of LRRC.

Childhood outcomes after prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the ORACLE I trial.

BACKGROUND: The ORACLE I trial compared the use of erythromycin and/or amoxicillin-clavulanate (co-amoxiclav) with that of placebo for women with preterm rupture of the membranes without overt signs of clinical infection, by use of a factorial randomised design. The aim of the present study--the ORACLE Children Study I--was to determine the long-term effects on children of these interventions. METHODS: We assessed children at age 7 years born to the 4148 women who had completed the ORACLE I trial and who were eligible for follow-up with a structured parental questionnaire to assess the child's health status. Functional impairment was defined as the presence of any level of functional impairment (severe, moderate, or mild) derived from the mark III Multi-Attribute Health Status classification system. Educational outcomes were assessed with national curriculum test results for children resident in England. FINDINGS: Outcome was determined for 3298 (75%) eligible children. There was no difference in the proportion of children with any functional impairment after prescription of erythromycin, with or without co-amoxiclav, compared with those born to mothers who received no erythromycin (594 [38.3%] of 1551 children vs 655 [40.4%] of 1620; odds ratio 0.91, 95% CI 0.79-1.05) or after prescription of co-amoxiclav, with or without erythromycin, compared with those born to mothers who received no co-amoxiclav (645 [40.6%] of 1587 vs 604 [38.1%] of 1584; 1.11, 0.96-1.28). Neither antibiotic had a significant effect on the overall level of behavioural difficulties experienced, on specific medical conditions, or on the proportions of children achieving each level in reading, writing, or mathematics at key stage one. INTERPRETATION: The prescription of antibiotics for women with preterm rupture of the membranes seems to have little effect on the health of children at 7 years of age. FUNDING: UK Medical Research Council.