bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long‐term follow‐up of dynamic graciloplasty for faecal incontinence
Authors: Thornton M. J. , Kennedy M. L. , Lubowski D. Z. , King D. W. 
Published: December 2004

AbstractObjective  This paper presents the long‐term morbidity, function and quality of life data for patients who have undergone dynamic graciloplasty (DGP) for faecal incontinence.Patients and methods  All patients (n = 38) who had undergone DGP at one institution between 1993 and 2003 are presented. Thirty‐three were available for long‐term follow‐up (median 60 months) and completed a telephone questionnaire assessing quality of life (QOL), bowel and sexual function and patient satisfaction. All patients had interval anorectal physiology studies.Results  At a median follow‐up of 5 years, 72% had pain, swelling or paraesthesia in the donor leg and 27% had sexual dysfunction. Sixteen percent of patients had been converted to an end‐colostomy for persisting incontinence and 11% for obstructed defaecation. All other patients have a normally functioning graciloplasty. Sixteen percent of patients reported a faecal continence score < 12. Of those patients with a functioning graciloplasty, 50% had obstructed defaecation and 64% reported that their bowel dysfunction had a negative impacted on their QOL. Age, medical comorbidity and anal manometry did not correlate with functional outcome. Quality of life scores and patient satisfaction scores correlated significantly with continence scores. There was a trend toward higher QOL and satisfaction scores with conversion to colostomy compared with a continence score > 12. Sixty percent of patients rated their satisfaction with DGP as 50% or better on a visual analogue scale, and this correlated strongly with the continence score at the time of the assessment (P < 0.001).Conclusion  Dynamic graciloplasty significantly improves patient quality of life and anal continence for some patients. Despite increased experience, morbidity remains high and long‐term continence scores are poor in a majority of cases. Obstructed defaecation is a significant problem after graciloplasty and antegrade colonic enemas may be needed. Significant prognostic factors for obstructed defaecation remain to be identified. The mechanism of both continence failure and surgical morbidity remains poorly defined in many patients and requires further investigation. The individual patient can expect a 16% chance of normal faecal continence at 5 years, with at least one surgical morbidity as a result of the procedure.
Effects of ovariectomy and hormone replacement on submucosal collagen and blood vessels of the anal canal of rats
Authors: Mensah‐Brown E. P. , Rizk Diaa E. E. , Patel Mahendra , Chandranath Swaminathan I. , Adem Abdu 
Published: December 2004

AbstractObjective  To study the effects of oestrogen and progesterone on submucosal collagen fibres and vascular plexus of the anal canal.Materials and methods  Experiments were performed on sections of the anal canal of ovariectomized rats following 28 daily subcutaneous injections of 17‐β oestradiol (n = 6, OVX + E, Group 1), medroxyprogesterone acetate (n = 6, OVX + P, Group 2), both drugs (n = 6, OVX + E + P, Group 3) or vehicle (n = 6, OVX) and after sham surgery without castration or injection (n = 6). Investigations included immunohistochemistry of oestrogen and progesterone receptors and collagen fibres, Western blot analysis of collagen types I and III and counting of perianal vessels by light microscopy.Results  There was positive immunostaining for oestrogen and progesterone receptors in the mucosa and for collagen types I and III in the submucosa in all samples. Type I collagen levels increased significantly with ovariectomy but were normalized with treatment with oestrogen and progesterone. Type III collagen levels decreased after ovariectomy. Administration of oestrogen and progesterone appeared to restore level to near sham values. Semi‐quantitative measurement of Type I/III collagen ratios by signal intensity demonstrated a very high ratio after ovariectomy. This appeared to be restored by both oestrogen and progesterone administration either individually or in combination. Mean vessel count was significantly lower in sham animals compared to values in OVX animals (P = 0.006). However, while only oestrogen treatment increased significantly the number of vessels compared to sham animals (P = 0.04), replacement with progesterone did not affect and in combination with oestrogen reduced submucosal vessel number.Conclusion  Oestrogen and progesterone have synergistic effects on collagen types I and III and probably antagonistic effects on the vascular plexus of the anal canal submucosa in adult female rats.
The risk of dysplasia and cancer in the ileal pouch mucosa after restorative proctocolectomy for ulcerative proctocolitis is low: A long‐term term follow‐up study
Authors: Börjesson L. , Willén R. , Haboubi N. , Duff S. E. , Hultén L. 
Published: December 2004

AbstractAim  Some of the rare complications reported in patients with an ileopouch anal anastomosis (IPAA) after coloectomy for chronic ulcerative colitis are dysplasia and carcinoma. The supposed pathway is for the ileal pouch mucosa to go through adaptational changes then is to progress through the phases of chronic pouchitis, dysplasia and subsequently to adenocarcinoma. In many of these studies however, the dysplasia – cancer sequence is inconclusive since the carcinoma might have developed from the ileal mucosa itself or from residual viable rectal mucosa left behind. The purpose of this study was therefore to study the long‐term ileal mucosal adaptation patterns and the incidence and grading of dysplasia in the ileal pouch mucosa in patients previously operated on for ulcerative proctocolitis.Patients and methods  Forty‐five patients who had been operated on with an IPAA (25 males/20 females), with a median age of 54 years (range 34–76), were invited for clinical examination and pouch endoscopy including mucosal biopsies. The duration of their colitis until surgery was median 6 years (range 1–28) and the time median interval from start of disease until time of follow up 24.8 years (range 17–46). Three independent pathologists from two different centres reviewed sequential mucosal biopsies taken from separate sites of the pouch for dysplasia and mucosal adaptation patterns.Results  The type C pattern with a severe inflammation in lamina propria together with severe atrophy of villi, sometimes with ulceration and granulation tissue, was observed by the two pathologists from one centre in 15 of 45 (33.3%) patients and in 11 (24.4%) of 45 by the third pathologist, respectively. As regards dysplasia one pathologist group evaluated 2/45 (4.4%) cases as low‐grade dysplasia while the third pathologist considered one of these cases as indefinite for dysplasia and one as reactive. There was in this respect full agreement between the two centres in 43 (95.6%) of 45 cases. Neither high‐grade dysplasia nor invasive carcinoma was diagnosed.Conclusion  Dysplastic transformation within the ileal pouch mucosa in patients operated for ulcerative proctocolitis is rare even after a long follow‐up. These results are reassuring for both patients and surgeons. There seem to be no solid grounds to support routine surveillance for dysplasia in the ileal pouch mucosa in these patients. The surveillance for neoplastic changes in the remaining muscular/epithelial cuff is a separate issue however.
Effectiveness and safety of the oxytocin antagonist atosiban versus beta‐adrenergic agonists in the treatment of preterm labour
Authors:   The Worldwide Atosiban versus Beta‐agonists Study Group Participants are listed in
Published: December 2004

Objective To compare the effectiveness and safety of the oxytocin antagonist atosiban with conventional beta‐adrenergic agonist (beta‐agonist) therapy in the treatment of preterm labour.Design Three multinational, multicentre, double‐blind, randomised, controlled trials.Setting Hospitals in Australia, Canada, Czech Republic, Denmark, France, Israel, Sweden, and the UK.Population Women diagnosed with preterm labour at 23–33 completed weeks of gestation.Methods Seven hundred and forty‐two women were randomised; 733 received atosiban (n=363; intravenous (iv) bolus dose of 6.75 mg, then 300 μg/minute iv. for 3h and 100 μg/min iv thereafter) or beta‐agonist (n=379; ritodrine, salbutamol or terbutaline iv; dose titrated) for at least 18h and up to 48 hours. Uterine contraction rate, cervical dilatation and effacement were used to assess progression of labour. An all patients treated analysis, using the Cochran‐Mantel‐Haenszel test, was performed.Main outcome measures Tocolytic effectiveness was assessed in terms of the number of women undelivered after 48 hours and seven days. Safety was assessed in terms of maternal side effects and neonatal morbidity.Results There were no significant differences between atosiban and β‐agonists in delaying delivery for 48h (88.1% vs 88.9%; P=0.99) or seven days (79.7% versus 77.6%; P=0.28). Tocolytic effectiveness was also similar in terms of mean [SD] gestational age at delivery (35.8 [3.9] weeks vs 35.5 [4.1] weeks) and mean [SD] birthweight (2491 [813] g versus 2461 [831] g). Maternal side effects, particularly cardiovascular adverse events (8.3% vs 81.2%, P < 0.001), were reported more frequently in women given β‐agonists, resulting in more treatment discontinuations due to side effects (1.1% vs 15.4%, P=0.0001). No statistical differences in neonatal/infant outcomes were observed with either study medication.Conclusions In the largest study of tocolytic therapy to date, atosiban was comparable in clinical effectiveness to conventional beta‐agonist therapy, but was associated with fewer maternal cardiovascular side effects. We conclude that atosiban has clinical advantages over current tocolytic therapy.
Oxytocin mRNA content in the endometrium of non‐pregnant women
Authors: Steinwall Margareta , Hansson Stefan , Bossmar Thomas , Larsson Iréne , Pilka Radovan , Åkerlund Mats 
Published: December 2004

Objective  To study oxytocin mRNA in the human endometrium at different phases of the menstrual cycle.Design  An exploratory study in non‐pregnant women.Setting  The Department of Obstetrics and Gynecology, Lund University Hospital, Sweden.Participants  Thirty‐three women of fertile age undergoing hysterectomy or endometrial curettage on routine benign gynaecologic indications.Methods  Endometrial tissue was obtained throughout the menstrual cycle. The presence of oxytocin mRNA was investigated by in situ hybridisation and by real time PCR.Main outcome measures  Oxytocin mRNA signalling intensity found by in situ hybridisation of tissue obtained at different times of the menstrual cycle. Relative amounts of oxytocin mRNA measured by real time PCR.Results  The signal for oxytocin mRNA obtained by in situ hybridisation was more pronounced in glandular epithelial cells than in stromal cells. Furthermore, it was most marked around mid‐cycle. The expression of oxytocin mRNA was confirmed by real time PCR.Conclusions  The results indicate that oxytocin may be synthesised in the endometrium of non‐pregnant women, particularly in the glandular epithelial cells. Hormone released from these sources may have a paracrine action on the uterus. Oxytocin mRNA expression seems to be ovarian hormone dependent with the highest concentration around mid‐cycle.
Duloxetine versus placebo in the treatment of European and Canadian women with stress urinary incontinence
Authors: van Kerrebroeck Philip , Abrams Paul , Lange Rainer , Slack Mark , Wyndaele Jean‐Jacques , Yalcin Ilker , Bump Richard C. ,   for the Duloxetine UI Study Group
Published: December 2004

Objective  To assess the efficacy and safety of duloxetine in women with stress urinary incontinence.Design  Randomised double‐blind, placebo‐controlled clinical trial.Setting  Fort‐six centres in seven European countries and Canada.Population  Four hundred and ninety‐four women aged 24–83 years identified as having predominant symptoms of stress urinary incontinence using a clinical algorithm that was 100% predictive of urodynamic stress urinary incontinence in a subgroup of 34 women.Methods  The case definition included a predominant symptom of stress urinary incontinence with a weekly incontinence episode frequency ≥7, the absence of predominant symptoms of urge incontinence, normal diurnal and nocturnal frequencies, a bladder capacity ≥400 mL and both a positive cough stress test and positive stress pad test. Subjects completed two urinary diaries prior to randomisation and three diaries during the active treatment phase of the study, each completed during the week prior to monthly visits. Subjects also completed quality of life questionnaires at each visit. Safety was assessed by the evaluation of treatment‐emergent adverse events, discontinuation of treatment because of adverse events, serious adverse events, vital sign measurements, electrocardiograms (ECG) and clinical laboratory tests.Intervention  After a two‐week placebo lead‐in, women received placebo or duloxetine 40 mg BD for 12 weeks.Main outcome measures  The percentage decrease in incontinence episode frequency and the change in the Incontinence Quality of Life (I‐QOL) questionnaire total score were prespecified as co‐primary outcome variables in the protocol.Results  Incontinence episode frequency decreased significantly with duloxetine compared with placebo (median decrease of 50%vs 29%; P= 0.002) with comparable improvements in the more severely incontinent subgroup (those experiencing at least 14 incontinence episodes per week at baseline; 56%vs 27% decreases; P < 0.001). The primary analysis of I‐QOL scores did not reveal a significant difference between treatment groups, due primarily to the carrying forward of low scores from patients who discontinued treatment very early due to duloxetine‐associated adverse events. The increase in I‐QOL scores was significantly greater for duloxetine than for placebo at each of the three postrandomisation visits after 4, 8, and 12 weeks of treatment. Discontinuation rates for adverse events were higher for duloxetine (22%vs 5%; P < 0.001) with nausea being the most common reason for discontinuation (5.3%). Nausea tended to be mild to moderate, not progressive, and transient.Conclusions  The findings support duloxetine as a potential treatment for women with stress urinary incontinence.
Needle versus loop diathermy excision of the transformation zone for the treatment of cervical intraepithelial neoplasia: a randomised controlled trial
Authors: Panoskaltsis Theo , Ind Thomas Edward James , Perryman Karen , Dina Roberto , Abrahams Yusuf , Soutter W. Patrick 
Published: December 2004

Objective  To determine whether lowwwer rates or incomplete resection of cervical intraepithelial neoplasia (CIN) may be achieved by needle excision of the transformation zone (NETZ) than with loop excision (LLETZ).Design A prospective randomised controlled trial.Setting A gynaecological oncology centre and a teaching hospital in West London.Population Four hundred and four women due to receive treatment for suspected CIN.Methods  Women were randomised to receive either LLETZ or NETZ.Main outcome measures The study was designed to demostrate a difference in the proportion of women with clear histological margins of 82% for LLETZ compared to 94% for NETZ with 90% power at a 5% significance level, allowing for absence of CIN in the treatment specimen in 15%.Results  Four randomised women were excluded from the analysis, as they were ineligible for the study. Three hundred and forty‐seven (87%) had CIN in the treatment specimen and could be included in the analysis of excision margins. More women in the NETZ arm had clear histological margins (84.8%vs 75%, (P= 0.03). The median volume of specimens in the NETZ arm was 739 mm3 larger (P= 0.33) and they were less likely to be removed in multiple pieces (2.5%vs 29.5%, RR 0.09, 95% CI 0.04 to 0.20). Needle excision took longer to perform (median treatment time 210 vs 90 seconds, P<0.0001) and surgeons more often reported the procedure as ‘difficult’ (9.5%vs 3.0%, RR = 3.17%, 95% CI 1.33 to 7.58). No difference in peri‐operative or post‐operative complication rates could be demonstrated between the two groups.Conclusion  NETZ is more likely to produce a specimen in one piece and with clear margins compared to LLETZ.
Preventing postnatal depression in mothers of very preterm infants: a randomised controlled trial
Authors: Hagan Ronald , Evans Sharon F. , Pope Sherryl 
Published: December 2004

Objective  To test whether a cognitive–behaviour therapy intervention program reduces the prevalence of depression during the first postnatal year in mothers of very preterm babies.Design  Prospective, single blind, randomised, controlled study.Setting  Perinatal centre in Western Australia.Participants  One hundred and ninety‐nine out of 673 English‐speaking mothers of infants admitted to the neonatal unit.Intervention  A six‐session cognitive–behaviour therapy intervention program provided by a research midwife between weeks two and six after birth. Women in the control group received standard care.Main outcome measures  Depression and anxiety disorders occurring in the first year assessed by a clinical psychologist at structured interview using the Schedule for Affective Disorders and Schizophrenia (SADS) at 2 weeks, 2, 6 and 12 months.Results  One hundred and one women were randomised to the intervention group and 98 to the control group. Fifty‐four mothers (27%) in the trial were diagnosed with minor or major depression in the 12 months following very preterm delivery, 29 (29%) in the intervention group and 25 (26%) in the control group (relative risk 1.1 [95% CI 0.80–1.5]). There were no differences in the time of onset or the duration of the episodes of depression between the groups. Overall, 74 mothers (37%) of the 199 met criteria for a diagnosis of psychological morbidity during the first year.Conclusions  Our intervention program did not alter the prevalence of depression in these mothers. Rates of depression and stress reactions are high in these mothers.
Pregnancy outcome in women with heart disease undergoing induction of labour
Authors: Oron Galia , Hirsch Rafael , Ben‐Haroush Avi , Hod Moshe , Gilboa Yinon , Davidi Ofer , Bar Jacob 
Published: December 2004

Objective  To examine the safety and outcome of induction of labour in women with heart disease.Design  Prospective single‐centre comparative study.Setting  Major university‐based medical centre.Population/Sample  One hundred and twenty‐one pregnant women with heart disease.Methods  The sample included all women with acquired or congenital heart disease who attended our High‐Risk Pregnancy Outpatient Clinic from 1995 to 2001. The files were reviewed for baseline data, cardiac and obstetric history, course of pregnancy and induction of labour and outcome of pregnancy. Findings were compared between women who underwent induction of labour and those who did not. Forty‐seven healthy women in whom labour was induced for obstetric reasons served as controls.Main outcome measures  Pregnancy outcome.Results  Of the 121 women with heart disease, 47 (39%) underwent induction of labour. There was no difference in the caesarean delivery rate after induction of labour between the women with heart disease (21%) and the healthy controls (19%). Although the women with heart disease had a higher rate of maternal and neonatal complications than controls (17%vs 2%, P= 0.015), within the study group, there was no difference in complication rate between the patients who did and did not undergo induction of labour.Conclusion  Induction of labour is a relatively safe procedure in women with cardiac disease. It is not associated with a higher rate of caesarean delivery than in healthy women undergoing induction of labour for obstetric indications, or with more maternal and neonatal complications than in women with a milder form of cardiac disease and spontaneous labour.
Antisepsis for abdominal hysterectomy: a randomised controlled trial of povidone–iodine gel
Authors: Eason E. , Wells G. , Garber G. , Hemmings R. , Luskey G. , Gillett P. , Martin M. ,   for the Vaginal Antisepsis For Abdominal Hysterectomy Study Group (other members listed in the Acknowledgements).
Published: December 2004

Objective  To assess whether infectious morbidity after total abdominal hysterectomy is decreased by the addition of 20 cc povidone–iodine gel at the vaginal apex after the usual vaginal preparation with povidone–iodine solution.Study design  Randomised controlled trial.Setting  Fifteen secondary and tertiary hospitals in Canada.Sample  A total of 1570 women undergoing planned total abdominal hysterectomy.Methods  Computer‐generated randomisation using a centralised telephone service was stratified by study centre with variable block size. In the operating room, a swab for bacterial vaginosis was taken before vaginal antisepsis. Study group remained concealed until the standard surgical preparation in the operating room was complete. Then povidone‐iodine gel 20 cc was placed at the vaginal apex in the intervention group only. Participants were followed for one month post‐operative.Main outcome measures  The primary outcome was post‐operative infectious morbidity during the 30 days after surgery, defined as: febrile morbidity with hospital stay greater than five days or antibiotic treatment, or infection requiring readmission to hospital or additional visit. Other outcomes included abdominal wound infection, pelvic abscess and other pelvic infections.Results  Post‐operative infectious morbidity within 30 days occurred in 128/780 (16%) women receiving povidone–iodine gel preparation and 142/790 (18%) women not receiving gel (RR 0.9, 95% CI 0.7 to 1.1). Pelvic abscess was diagnosed in 0 patients in the gel group and in seven patients in the control group (P < 0.01). No significant difference was found in pelvic cellulitis (eight in each group) or abdominal wound infection (51 in the gel group and 58 in the control group, P= 0.5).Conclusion  Povidone–iodine vaginal gel antisepsis led to a 9% relative decrease in overall infectious morbidity after abdominal hysterectomy, which was not statistically significant. Povidone–iodine vaginal gel decreased the risk of pelvic abscess after total abdominal hysterectomy.