Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial.

BACKGROUND: Duration of bladder catheterisation after female genital fistula repair varies widely. We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula. METHODS: In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hospitals in the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda. Consenting patients were eligible if they had a simple fistula that was closed after surgery and remained closed 7 days after surgery, understood study procedures and requirements, and agreed to return for follow-up 3 months after surgery. We excluded women if their fistula was not simple or was radiation-induced, associated with cancer, or due to lymphogranuloma venereum; if they were pregnant; or if they had multiple fistula. A research assistant at each site randomly allocated participants 1:1 (randomly varying block sizes of 4-6; stratified by country) to 7 day or 14 day bladder catheterisation (via a random allocation sequence computer generated centrally by WHO). Outcome assessors were not masked to treatment assignment. The primary outcome was fistula repair breakdown, on the basis of dye test results, any time between 8 days after catheter removal and 3 months after surgery. The non-inferiority margin was 10%, assessed in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT01428830. FINDINGS: We randomly allocated 524 participants between March 7, 2012, and May 6, 2013; 261 in the 7 day group and 263 in the 14 day group. In the per-protocol analysis, ten (4%) of 250 patients had repair breakdown in the 7 day group (95% CI 2-8) compared with eight (3%) of 251 (2-6) in the 14 day group (risk difference 0·8% [95% CI -2·8 to 4·5]), meeting the criteria for non-inferiority. INTERPRETATION: 7 day bladder catheterisation after repair of simple fistula is non-inferior to 14 day catheterisation and could be used for management of women after repair of simple fistula with no evidence of a significantly increased risk of repair breakdown, urinary retention, or residual incontinence up to 3 months after surgery. FUNDING: US Agency for International Development.

Mortality risk associated with surgical treatment of female genital fistula.

OBJECTIVE: To describe the mortality risk associated with surgical treatment of female genital fistula and the contributory and contextual factors. METHODS: In a descriptive study, confidential inquiries and clinical audits were conducted at 14 fistula repair sites in seven resource-poor countries between January 2005 and March 2013. Data collection included interviews with key personnel involved in the clinical management of the deceased, and a review of hospital records and patient files following an audit protocol. RESULTS: Overall, 26060 fistula repairs were performed at 44 sites located in 13 countries; 30 deaths were reported in this period. Twenty-one deaths were attributable to surgery, yielding a case fatality of 0.08 per 100 procedures. The cause of death in nearly half of the cases was various manifestations of sepsis and inflammation. CONCLUSION: The case fatality rate for fistula repair surgery in resource-poor countries was in the same range as that for comparable gynecologic operations in high-resource settings. Clinical and systemic issues to be addressed to reduce the case fatality rate include improvement of perioperative care and follow-up, assuring prudent referral or deferral of difficult cases, and maintaining better records.

Assessing the quality of record keeping for cesarean deliveries: results from a multicenter retrospective record review in five low-income countries.

BACKGROUND: Reliable, timely information is the foundation of decision making for functioning health systems; the quality of decision making rests on quality data. Routine monitoring, reporting, and review of cesarean section (CS) indications, decision-to-delivery intervals, and partograph use are important elements of quality improvement for maternity services. METHODS: In 2009 and 2010, a sample of CS records from calendar year 2008 was reviewed at nine facilities in Bangladesh, Guinea, Mali, Niger, and Uganda. Data from patient records and hospital registers were collected on key aspects of care such as timing of key events, indications, partograph use, maternal and fetal outcomes. Qualitative interviews were conducted with key informants at all study sites to provide contextual background about CS services and record keeping practices. RESULTS: A total of 2,941 records were reviewed and 57 key informant interviews were conducted. Patient record-keeping systems were of varying quality across study sites: at five sites, more than 20% of records could not be located. Across all sites, patient files were missing key aspects of CS care: timing of key events (e.g., examination, decision to perform CS), administration of prophylactic antibiotics, maternal complications, and maternal and fetal outcomes. Rates of partograph use were low at six sites: 0 to 23.9% of patient files at these sites had a completed partograph on file, and among those found, 2.1% to 65.1% were completed correctly. Information on fetal outcomes was missing in up to 40% of patient files. CONCLUSIONS: Deficits in the quality of CS patient records across a broad range of health facilities in low-resource settings in four sub-Saharan Africa countries and Bangladesh indicate an urgent need to improve record keeping.

Community-based screening for obstetric fistula in Nigeria: a novel approach.

BACKGROUND: Obstetric fistula continues to have devastating effects on the physical, social, and economic lives of thousands of women in many low-resource settings. Governments require credible estimates of the backlog of existing cases requiring care to effectively plan for the treatment of fistula cases. Our study aims to quantify the backlog of obstetric fistula cases within two states via community-based screenings and to assess the questions in the Demographic Health Survey (DHS) fistula module. METHODS: The screening sites, all lower level health facilities, were selected based on their geographic coverage, prior relationships with the communities and availability of fistula surgery facilities in the state. This cross-sectional study included women who presented for fistula screenings at study facilities based on their perceived fistula-like symptoms. Research assistants administered the pre-screening questionnaire. Nurse-midwives then conducted a medical exam. Univariate and bivariate analyses are presented. RESULTS: A total of 268 women attended the screenings. Based on the pre-screening interview, the backlog of fistula cases reported was 75 (28% of women screened). The backlog identified after the medical exam was 26 fistula cases (29.5% of women screened) in Kebbi State sites and 12 cases in Cross River State sites (6.7%). Verification assessment showed that the DHS questionnaire had 92% sensitivity, 83% specificity with 47% positive predictive value and 98% negative predictive value for identifying women afflicted by fistula among women who came for the screenings. CONCLUSIONS: This methodology, involving effective, locally appropriate messaging and community outreach followed up with medical examination by nurse-midwives at lower level facilities, is challenging, but represents a promising approach to identify the backlog of women needing surgery and to link them with surgical facilities.

Histopathology of cryoballoon ablation-induced phrenic nerve injury.

INTRODUCTION: Hemi-diaphragmatic paralysis is the most common complication associated with cryoballoon ablation for atrial fibrillation, yet the histopathology of phrenic nerve injury has not been well described. METHODS AND RESULTS: A preclinical randomized study was conducted to characterize the histopathology of phrenic nerve injury induced by cryoballoon ablation and assess the potential for electromyographic (EMG) monitoring to limit phrenic nerve damage. Thirty-two dogs underwent cryoballoon ablation of the right superior pulmonary vein with the objective of inducing phrenic nerve injury. Animals were randomized 1:1 to standard monitoring (i.e., interruption of ablation upon reduction in diaphragmatic motion) versus EMG guidance (i.e., cessation of ablation upon a 30% reduction in the diaphragmatic compound motor action potential [CMAP] amplitude). The acute procedural endpoint was achieved in all dogs. Phrenic nerve injury was characterized by Wallerian degeneration, with subperineural injury to large myelinated axons and evidence of axonal regeneration. The degree of phrenic nerve injury paralleled the reduction in CMAP amplitude (P = 0.007). Animals randomized to EMG guidance had a lower incidence of acute hemi-diaphragmatic paralysis (50% vs 100%; P = 0.001), persistent paralysis at 30 days (21% vs 75%; multivariate odds ratio 0.12, 95% confidence interval [0.02, 0.69], P = 0.017), and a lesser severity of histologic injury (P = 0.001). Mature pulmonary vein ablation lesion characteristics, including circumferentiality and transmurality, were similar in both groups. CONCLUSION: Phrenic nerve injury induced by cryoballoon ablation is axonal in nature and characterized by Wallerian degeneration, with potential for recovery. An EMG-guided approach is superior to standard monitoring in limiting phrenic nerve damage.

Profiles and experiences of women undergoing genital fistula repair: findings from five countries.

This article presents data from 1354 women from five countries who participated in a prospective cohort study conducted between 2007 and 2010. Women undergoing surgery for fistula repair were interviewed at the time of admission, discharge, and at a 3-month follow-up visit. While women's experiences differed across countries, a similar picture emerges across countries: women married young, most were married at the time of admission, had little education, and for many, the fistula occurred after the first pregnancy. Median age at the time of fistula occurrence was 20.0 years (interquartile range 17.3-26.8). Half of the women attended some antenatal care (ANC); among those who attended ANC, less than 50% recalled being told about signs of pregnancy complications. At follow-up, most women (even those who were not dry) reported improvements in many aspects of social life, however, reported improvements varied by repair outcome. Prevention and treatment programmes need to recognise the supportive role that husbands, partners, and families play as women prepare for safe delivery. Effective treatment and support programmes are needed for women who remain incontinent after surgery.

Pulmonary vein isolation using a second-generation cryoballoon catheter: a randomized comparison of ablation duration and method of deflation.

INTRODUCTION: Optimal cryoballoon ablation parameters for pulmonary vein (PV) isolation remain to be defined. We conducted a randomized preclinical trial to compare 2- versus 4-minute ablation lesions and assess the safety of active (forced) cryoballoon deflation. METHODS AND RESULTS: Thirty-two dogs underwent PV isolation with a second-generation 23 mm cryoballoon catheter. The left superior (LSPV) and inferior (LIPV) PVs were randomized in a factorial design to (1) a single 2- versus 4-minute cryoapplication, and (2) passive versus active cryoballoon deflation. Animals were survived for 30 days, after which histopathologic analysis was performed. Acute PV isolation was attained in 89.8% of PVs after a single application (93.8% LSPV, 85.2% LIPV; P = 0.2823). Mean time to PV isolation was 29.5 ± 18.5 seconds. Although 4-minute lesions were associated with a thicker neointima than 2-minute lesions (223.8 µm versus 135.6 µm; P = 0.007), no differences were observed in procedural characteristics (freezing temperature, rewarming time), rates of acute PV isolation, or the achievement of complete circumferentially transmural lesions at 30 days (78.7% overall; 86.2% for 2 minutes vs 70.0% for 4 minutes; P = 0.285). Active deflation was associated with faster balloon rewarming but not with significant differences in mean or maximum neointimal thickness. CONCLUSION: A single application with the second-generation cryoballoon catheter results in a high rate of PV isolation. The degree of vascular injury was not increased by active balloon deflation and no differences in acute efficacy or mature transmural circumferential lesions were observed with 2- versus 4-minute applications.

Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial.

BACKGROUND: A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day) urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day) urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. METHODS/DESIGN: This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT) comparing the new proposed short-term (7 day) urethral catheterization to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and self-reported residual incontinence. This trial will be conducted among 512 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 24 months at each site. DISCUSSION: If no major safety issues are identified, the data from this trial may facilitate adoption of short-term urethral catheterization following repair of simple fistula in sub-Saharan Africa and Asia. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01428830.

Diaphragmatic electromyography during cryoballoon ablation: a novel concept in the prevention of phrenic nerve palsy.

BACKGROUND: Hemidiaphragmatic paralysis is the most frequent complication associated with cryoballoon ablation for atrial fibrillation. To date, no preventive strategy has proved effective. OBJECTIVE: We sought to assess the feasibility of diaphragmatic electromyography during cryoballoon ablation, explore the relationship between altered signals and phrenic nerve palsy, and define characteristic changes that herald hemidiaphragmatic paralysis. METHODS: Cryoballoon ablation was performed in the right superior pulmonary vein or superior vena cava in 16 mongrel dogs weighing 37.7 ± 2.4 kg, at sites determined by phrenic nerve capture. During ablation, the phrenic nerve was paced at 60 bpm from the superior vena cava while recording diaphragmatic compound motor action potentials (CMAPs) by esophageal decapolar catheters. Diaphragmatic excursion was monitored by fluoroscopy and abdominal palpation. RESULTS: Before ablation, the CMAP amplitude was 592 (interquartile range 504, 566) µV, initial latency 21.5 ± 4.2 ms, peak latency 64.7 ± 21.1 ms, and duration 101.7 ± 13.3 ms. Hemidiaphragmatic paralysis was obtained in all dogs 62 ± 34 seconds into the cryoapplication. The CMAP amplitude decreased exponentially, with no patterned changes in latencies and duration. Discriminatory analyses by receiver-operating curve characteristics identified a 30% reduction in CMAP amplitude as the most predictive cutoff value for hemidiaphragmatic paralysis (c-statistic 0.965; P<.0001). This criterion presaged diaphragmatic paralysis, as detected by abdominal palpation, by 31 ± 23 seconds. CONCLUSION: Diaphragmatic electromyographic signals could be reliably recorded during cryoballoon ablation. An exponential decrease in CMAP amplitude precedes diaphragmatic paralysis, with a 30% reduction yielding the best discriminatory potential. A promising safety margin was detected, which merits prospective validation.

Enlargement of catheter ablation lesions in infant hearts with cryothermal versus radiofrequency energy: an animal study.

BACKGROUND: Radiofrequency catheter ablation in immature hearts has been associated with marked enlargement of lesions over time, with potential for related late adverse events. It remains unknown whether cryothermal ablation lesions display a similar pattern of growth. METHODS AND RESULTS: Ablation lesions (n=384) were performed in 32 infant miniature swine in right and left atria, ventricles, and atrioventricular (AV) grooves preselected by a randomized factorial design devised to compare radiofrequency and cryothermal lesions produced by 7F 4-mm electrode-tip catheters. Animals were euthanized acutely or at 1, 6, or 12 months, according to the randomization scheme. The miniature swine weighed 8.8±1.2 kg and were 63±13 days of age at time of ablation. The minimum temperature during cryoablation was -79.8±3.4°C and the average temperature during radiofrequency ablation was 54.4±5.5°C. On morphometric analyses, no differences in the rate of growth of ablation lesions were noted between the 2 energy modalities in atria (P=0.44), ventricles (P=0.57), or AV grooves (P=0.69). Lesion volumes increased 3.3-fold in atria (95% confidence interval [CI], 2.3 to 4.3; P=0.001) and 2.2-fold in ventricles (95% CI, 1.4 to 3.0; P<0.0001), with the difference between chambers being nonsignificant (P=0.22). Whereas the depth of AV groove lesions increased over time (1.9-fold; 95% CI, 1.5 to 2.3; P<0.0001), lesion volumes did not enlarge significantly (1.5-fold; 95% CI, 0.4 to 2.6; P=0.45). CONCLUSIONS: Ablation lesions produced by cryothermal energy in immature atrial and ventricular myocardium enlarge to a similar extent to radiofrequency ablation. In contrast, AV groove lesion volumes do not increase significantly with either energy modality.

Current practices in treatment of female genital fistula: a cross sectional study.

BACKGROUND: Maternal outcomes in most countries of the developed world are good. However, in many developing/resource-poor countries, maternal outcomes are bleaker: Every year, more than 500,000 women die in childbirth, mostly in resource-poor countries. Those who survive often suffer from severe and long-term morbidities. One of the most devastating injuries is obstetric fistula, occurring most often in south Asia and sub-Saharan Africa. Fistula treatment and care are available in many countries across Africa and Asia, but there is a lack of reliable data around clinical factors associated with the success of fistula repair surgery. Most published research has been retrospective. While these studies have provided useful information about the care and treatment of fistula, they are limited by the design. This study was designed to identify practices in care that could lead to the design of prospective and randomized controlled trials. METHODS: Self-administered questionnaires were completed by 40 surgeons known to provide fistula treatment services in Africa and Asia at private and government hospitals. The questionnaire was divided into three parts to address the following issues: prophylactic use of antibiotics before, during, and after fistula surgery; urethral catheter management; and management practices for patients with urinary incontinence following fistula repair. RESULTS: The results provide a glimpse into current practices in fistula treatment and care across a wide swath of geographic, economic, and organizational considerations. There is consensus in treatment in some areas (routine use of prophylactic antibiotics, limited bed rest until the catheter is removed, nonsurgical treatment for postsurgical incontinence), while there are wide variations in practice in other areas (duration of catheter use, surgical treatments for postsurgical incontinence). These findings are based on a small sample and do not allow for recommending changes in clinical care, but they point to issues for possible clinical trial research that would contribute to more efficient and effective fistula care. CONCLUSIONS: The findings from the survey allowed us to consider clinical practices most influential in the cost, efficacy, and safety of fistula treatment. These considerations led us to formulate recommendations for eight randomized controlled trials on the following subjects: 1) Efficacy/safety of short-term catheterization; 2) efficacy of surgical and nonsurgical therapies for urinary incontinence; 3) technical measures during fistula repair to reduce the incidence of post-surgery incontinence; 4) identification of predictive factors for "incurable fistula"; 5) usefulness of urodynamic studies in the management of urinary incontinence; 6) incidence and significance of multi-drug resistant bacteria in the fistula population; 7) primary management of small, new fistulas by catheter drainage; and 8) antibiotic prophylaxis in fistula repair.

Distribution of contraceptives in factories in St. Lucia

In 1980 the St. Lucia Family Planning Association sponsored a project to deliver family planning services and contraceptives to female factory workers in St. Lucia. The project received the support of management, since many female workers fell into the high-fertility (20 to 30 year-old) age group, and unwanted pregnancies led to increased staff turnover and the additional costs of paid maternity benefits. However, contraceptive use as a result of the project was never monitored, nor was the project's overall cost-effectiveness. In 1981 the project was discontinued due to lack of funding. The following year an operations research project was undertaken to test two alternative systems for the delivery of family planning services in St. Lucia factories. This article describes the project methodology, target population, and results, and calculates the overall cost-effectiveness of family planning services in the factory environment. (AU)