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Biomedical subjects

Ray Garry

Publications and source records attributed to Ray Garry.

At least 19 recordsLinked to original sources
PubMed2006

Deeply infiltrating endometriosis affecting the rectum and lymph nodes.

OBJECTIVE: To analyze morphologic aspects of bowel endometriosis. DESIGN: Prospective study of 35 consecutive cases of bowel endometriosis. SETTING: Multidisciplinary group practice and teaching hospital. PATIENT(S): Thirty-five patients with bowel endometriosis were assessed between September 2003 and June 2005. INTERVENTION(S): Histologic analysis of 35 tissue samples removed at laparoscopic rectosigmoidectomy. MAIN OUTCOME MEASURE(S): We performed an evaluation of lesion size, number of lesions present in the bowel, intestinal wall layers affected by the endometriotic lesion, circumference of the intestinal loop affected by the endometriotic lesion, and presence of lymph nodes with foci of endometriosis. RESULT(S): Analysis of the surgical samples revealed lymph nodes in the pericolic adipose tissue of 19 (54%), cases and in 5 of these cases (26.3%), endometriosis had affected the lymph nodes. When the thickness of the endometriotic lesion reached 1.75 cm, lymph nodes of all patients were affected, and all patients in whom more than 80% of the circumference of the intestinal loop was affected by endometriosis presented with positive lymph nodes. CONCLUSION(S): This study raises doubts about whether this form of the disease can still be considered a clinically benign disease.

Adult↗
PubMed2006

Diagnosis of endometriosis and pelvic pain.

Both the American and the Royal Colleges of Obstetricians and Gynecologists have produced guidelines that recommend patients with chronic pelvic pain, including those suspected of having endometriosis, should receive empirical medical therapy without a preliminary diagnostic laparoscopy. This paper reviews the implications of this approach.

Adult↗
PubMed2006

Case report of failed tubal occlusion using Essure pbc (permanent birth control) hysteroscopic sterilisation procedure.

The device previously known as STOP, now called the Essure pbc device, is a dynamic expanding microinsert, placed in the proximal section of the fallopian tube, occluding the tube. Initial reports about the device are promising with occlusion of the tubes in 100% with no reported pregnancies and a high rate of safety and patient acceptability. This report documents the first reported failure of tubal occlusion of an appropriately placed Essure pbc device.

Adult↗
PubMed2005

Laparoscopic surgery.

The generic advantages of avoiding a large laparotomy incision are now well established. For the patient, a laparoscopic procedure is invariably less painful, and recovery and return to full normal activities is more rapid. There are also significant gains in short-term quality of life measures associated with the laparoscopic approach. For the surgeon, improved visualisation offers the opportunity of more precise and accurate surgery. These advantages are usually offset by longer operating times, the use of complex and expensive equipment, and the possibility of new types of complications and increased risk of standard operative morbidity. The aim of this chapter is to identify areas of general technique in which the risks associated with laparoscopic surgery can be minimised while retaining all the advantages of the approach. This is being achieved partly by improved and simplified instrumentation, partly by refinement in techniques, and partly by an increasing awareness of the potential pitfalls of the approach and by adopting strategies to avoid these problems. The majority of gynaecological procedures are already performed endoscopically and all gynaecologists who operate will need to become proficient in these techniques. This chapter outlines techniques for safe laparoscopic entry and safe bipolar diathermy techniques, and describes how to undertake some of the simpler laparoscopic procedures; the evidence supporting these approaches is also presented. Surgical proficiency in safe laparoscopic entry and laparoscopic tubal surgery should lead to the confidence to then undertake more complex procedures.

Abdominal Wall↗
PubMed2005

Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To evaluate the most appropriate surgical method of hysterectomy (abdominal, vaginal, or laparoscopic) for women with benign disease. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Cochrane Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials, Medline, Embase, and Biological Abstracts. SELECTION OF STUDIES: Only randomised controlled trials were selected; participants had to have benign gynaecological disease; interventions had to comprise at least one hysterectomy method compared with another; and trials had to report primary outcomes (time taken to return to normal activities, intraoperative visceral injury, and major long term complications) or secondary outcomes (operating time, other immediate complications of surgery, short term complications, and duration of hospital stay). RESULTS: 27 trials (total of 3643 participants) were included. Return to normal activities was quicker after vaginal than after abdominal hysterectomy (weighted mean difference 9.5 (95% confidence interval 6.4 to 12.6) days) and after laparoscopic than after abdominal hysterectomy (difference 13.6 (11.8 to 15.4) days), but was not significantly different for laparoscopic versus vaginal hysterectomy (difference -1.1 (-4.2 to 2.1) days). There were more urinary tract injuries with laparoscopic than with abdominal hysterectomy (odds ratio 2.61 (95% confidence interval 1.22 to 5.60)), but no other intraoperative visceral injuries showed a significant difference between surgical approaches. Data were notably absent for many important long term patient outcome measures, where the analyses were underpowered to detect important differences, or they were simply not reported in trials. CONCLUSIONS: Significantly speedier return to normal activities and other improved secondary outcomes (shorter duration of hospital stay and fewer unspecified infections or febrile episodes) suggest that vaginal hysterectomy is preferable to abdominal hysterectomy where possible. Where vaginal hysterectomy is not possible, laparoscopic hysterectomy is preferable to abdominal hysterectomy, although it brings a higher chance of bladder or ureter injury.

Female↗
PubMed2005

Health economics of hysterectomy.

Health resources are finite, and it is increasingly necessary to practise medicine within defined budgets. Hysterectomy is recognized as one of the most frequently performed of all major surgical operations and is of great economic as well as medical and social importance. A full assessment of the value of an intervention requires consideration of both economic and clinical outcomes. New alternative therapies to uterine excision have been introduced, and new ways of performing hysterectomy have been developed. Cost-effectiveness analysis enables each of these approaches to be meaningfully compared. Using such analytic techniques, hysterectomy can be shown to be an effective and cost-effective intervention across a variety of indications. The vaginal route is the most cost-effective approach. There seems to be no obvious advantage in conserving or retaining the cervix, but there is as yet no evidence about the cost-effectiveness of concomitant oophorectomy.

Cost-Benefit Analysis↗
PubMed2005

Excisional surgery versus ablative surgery for ovarian endometriomata: a Cochrane Review.

BACKGROUND: The objective of this review was to determine which is the most effective technique for treating an ovarian endometrioma; excision or ablation. METHODS: A systematic review employing the principles of the Cochrane Menstrual Disorders and Subfertility Group was undertaken. No randomized studies of the management of endometriomata by laparotomy were found. Two randomized studies of the laparoscopic management of ovarian endometriomata of >3 cm in size were included. RESULTS: Laparoscopic excision of the cyst wall of the endometrioma was associated with a reduced rate of recurrence of the endometrioma [odds ratio (OR) 0.41, confidence interval (CI) 0.18-0.93], reduced requirement for further surgery (OR 0.21, CI 0.05-0.79), reduced recurrence rate of the symptoms of dysmenorrhoea (OR 0.15, CI 0.06-0.38), dyspareunia (OR 0.08, CI 0.01-0.51) and non-menstrual pelvic pain (OR 0.10, CI 0.02-0.56). It was also associated with a subsequently increased rate of spontaneous pregnancy in women who had documented prior subfertility (OR 5.21, CI 2.04-13.29). CONCLUSIONS: There is some evidence that excisional surgery for endometriomata provides for a more favourable outcome than drainage and ablation, with regard to the recurrence of the endometrioma, recurrence of symptoms and subsequent spontaneous pregnancy in women who were previously subfertile. Consequently this should be the favoured surgical approach. However, we found no data to indicate the best surgical approach in women planning to undergo assisted reproductive techniques.

Endometriosis↗
PubMed2004

Psychometric properties of the Body Image Scale in women with benign gynaecological conditions.

OBJECTIVES: To evaluate the psychometric properties of the Body Image Scale (originally designed for use in cancer) in women with benign gynaecological conditions. STUDY DESIGN: Prospective completion of the Body Image Scale by women participating in the EVALUATE Hysterectomy Trial. The scale was completed pre-operatively, then 6 weeks, 4 and 12 months post-operatively. The psychometric properties were evaluated by assessing the reliability, response prevalence, discriminant validity and sensitivity to change. Factor analysis was also conducted to determine the scale structure. RESULTS: The Body Image Scale showed good reliability and clinical validity. Differences between sub-groups of women were detected, demonstrating good discriminant validity. The Body Image Scale was shown to be responsive to changes in body image. CONCLUSIONS: The Body Image Scale was shown to be a reliable and valid tool for assessing body image in women with benign gynaecological conditions and for use in clinical trials involving such women.

Adult↗
PubMed2004

Is insulin resistance an essential component of PCOS?: The endometriosis syndromes: a clinical classification in the presence of aetiological confusion and therapeutic anarchy.

Clinical confusion and inappropriate management continues to surround endometriosis. It is poorly recognized that the disorder can exist in two different morphological forms that have different symptoms, signs and prognosis. Earlier classification systems have been useful for research but are of limited value in aiding day-to-day management. In the clinic, two discrete phenotypes can be defined by the presence or absence of palpable nodules in the deep pelvis. Patients with such nodules with or without associated ovarian endometrioma usually have severe symptoms with significant risks of bowel and urinary tract involvement. The predominant histological feature of these lesions is extensive fibromuscular hyperplasia (adenomyoma). These patients will often need extensive surgical intervention. Patients without such palpable lesions usually have the classic superficial subperitoneal lesions with endometrial-like glands and stroma on histological examination. This group often has less severe symptoms and has little risk of developing serious associated problems. These lesions may be helped by medications and/or simple ablative surgery. It is suggested that these collections of symptoms and signs or syndromes be named after the pioneers who first described the lesions. Cullen's syndrome can be used to describe those patients with severe symptoms of endometriosis associated with palpable pelvic nodules. Sampson's syndrome can describe those with similar symptoms associated with a structurally normal pelvis.

Endometriosis↗
PubMed2004

Cost effectiveness analysis of laparoscopic hysterectomy compared with standard hysterectomy: results from a randomised trial.

OBJECTIVE: To assess the cost effectiveness of laparoscopic hysterectomy compared with conventional hysterectomy (abdominal or vaginal). DESIGN: Cost effectiveness analysis based on two parallel trials: laparoscopic (n = 324) compared with vaginal hysterectomy (n = 163); and laparoscopic (n = 573) compared with abdominal hysterectomy (n = 286). PARTICIPANTS: 1346 women requiring a hysterectomy for reasons other than malignancy. MAIN OUTCOME MEASURE: One year costs estimated from NHS perspective. Health outcomes expressed in terms of QALYs based on women's responses to the EQ-5D at baseline and at three points during up to 52 weeks' follow up. RESULTS: Laparoscopic hysterectomy cost an average of 401 pounds sterling (708 dollars; 571 euros) more (95% confidence interval 271 pounds sterling to 542 pounds sterling) than vaginal hysterectomy but produced little difference in mean QALYs (0.0015, -0.015 to 0.018). Mean differences in cost and QALYs generated an incremental cost per QALY gained of 267 333 pounds sterling (471 789 dollars; 380 437 euros). The probability that laparoscopic hysterectomy is cost effective was below 50% for a large range of values of willingness to pay for an additional QALY. Laparoscopic hysterectomy cost an average of 186 pounds sterling (328 dollars; 265 euros) more than abdominal hysterectomy, although 95% confidence intervals crossed zero (-26 pounds sterling to 375 pounds sterling); there was little difference in mean QALYs (0.007, -0.008 to 0.023), resulting in an incremental cost per QALY gained of 26 571 pounds sterling (46 893 dollars; 37 813 euros). If the NHS is willing to pay 30 000 pounds sterling for an additional QALY, the probability that laparoscopic hysterectomy is cost effective is 56%. CONCLUSIONS: Laparoscopic hysterectomy is not cost effective relative to vaginal hysterectomy. Its cost effectiveness relative to the abdominal procedure is finely balanced.

Cost-Benefit Analysis↗
PubMed2004

The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy.

OBJECTIVE: To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. DESIGN: Two parallel, multicentre, randomised trials. SETTING: 28 UK centres and two South African centres. PARTICIPANTS: 1380 women were recruited; 1346 had surgery; 937 were followed up at one year. Primary outcome Rate of major complications. RESULTS: In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, -5.2% to 5.8%), and the number needed to treat to harm was 333. We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. CONCLUSIONS: Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time.

Adult↗
PubMed2004

Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial.

OBJECTIVE: To examine the effect on pain and quality of life for women with all stages of endometriosis undergoing laparoscopic surgery compared with placebo surgery. DESIGN: A randomized, blinded, crossover study. SETTING: A tertiary referral unit in a district general hospital. PATIENT(S): Thirty-nine women with histologically proven endometriosis completed the 12-month study. INTERVENTION(S): Women were randomized to receive initially either a diagnostic procedure (the delayed surgical group) or full excisional surgery (the immediate surgery group). After 6 months, repeat laparoscopy was performed, with removal of any pathology present. MAIN OUTCOME MEASURE(S): The end points were changes from baseline values of visual analogue pain scores, validated quality-of-life instruments (EQ-5D and SF-12), and sexual activity questionnaire scores. Patients and assessors of outcomes were blinded to the treatment-group assignment. RESULT(S): Significantly more of the 39 women operated on according to protocol reported symptomatic improvement after excisional surgery than after placebo: 16 of 20 (80%) vs. 6 of 19 (32%); chi(2)(1) = 9.3. Other aspects of quality of life were also significantly improved 6 months after excisional surgery but not after placebo. Progression of disease at second surgery was demonstrated for women having only an initial diagnostic procedure in 45% of cases, with disease remaining static in 33% and improving in 22% of cases. Nonresponsiveness to surgery was reported in 20% of cases. CONCLUSION(S): Laparoscopic excision of endometriosis is more effective than placebo at reducing pain and improving quality of life. Surgery is associated with a 30% placebo response rate that is not dependent on severity of disease. Approximately 20% of women do not report an improvement after surgery for endometriosis.

Adult↗
PubMed2004

The effectiveness of laparoscopic excision of endometriosis.

PURPOSE OF REVIEW: The optimum method for the treatment of endometriosis remains unclear. This review explores recent data concerning the effectiveness of laparoscopic excision and associated therapies, to guide clinicians in their selection of the most appropriate therapeutic regimen. RECENT FINDINGS: Large, long-term, prospective studies and a placebo-controlled, randomized, controlled trial suggest that laparoscopic excision is an effective treatment approach for patients with all stages of endometriosis. The result of such laparoscopic excision may be improved if affected bowel, bladder and other involved structures are also excised. Adjuvant therapies such as the levonorgestrel intrauterine system and pre-sacral neurectomy may further improve outcomes. Ovarian endometrioma are invaginations of the uterine cortex, and surgical stripping of this cortex removes many primordial follicles. Despite this apparent disadvantage, stripping of the capsule is associated with better subsequent pregnancy rates and lower recurrence rates than the more conservative approach of thermal ablation to the superficial cortex. SUMMARY: Laparoscopic excision is currently the 'gold standard' approach for the management of endometriosis, and results may be improved with careful use of appropriate techniques and suitable adjuvant therapies.

Chemotherapy, Adjuvant↗
PubMed2003

A double-blind randomized trial comparing the Cavaterm and the NovaSure endometrial ablation systems for the treatment of dysfunctional uterine bleeding.

OBJECTIVE: To compare two second-generation endometrial ablation systems in women with dysfunctional uterine bleeding (DUB) who want conservative surgical treatment. DESIGN: A double-blind, randomized trial. SETTING: A minimal access gynecological surgery unit in northeast England. PATIENT(S): Fifty-seven women diagnosed with DUB were recruited, with 55 undergoing surgery and completing 12-month follow-up. INTERVENTION(S): Thirty-seven women underwent a NovaSure endometrial ablation, and 18 had a Cavaterm endometrial ablation. Clinical and quality of life data were collected 6 and 12 months after treatment. MAIN OUTCOME MEASURE(S): Amenorrhea, menstrual change, quality of life, sexual activity, patient satisfaction, and procedure acceptability. RESULT(S): Amenorrhea, hypomenorrhea, eumenorrhea, and menorrhagia rates for the Cavaterm and Novasure groups at 12 months were 2/18 (11%) vs. 16/37 (43%); 11/18 (61%) vs. 10/37 (27%); 5/18 (27%) vs. 6/37 (16%); and 0/18 vs. 5/37 (13%), respectively. At 12 months, 83% and 92% of women were either satisfied or very satisfied in the Cavaterm or Novasure groups, respectively. There were no major complications in either group. CONCLUSION(S): Both the Cavaterm and the Novasure endometrial ablation systems are effective in reducing menstrual loss in women with DUB and achieve high rates of patient satisfaction. The Novasure system achieved a statistically significantly higher rate of amenorrhea in this study.

Adult↗
PubMed2003

Quality of life should be considered the primary outcome for measuring success of endometrial ablation.

STUDY OBJECTIVE: To compare clinical and quality of life outcomes by validated instruments after endometrial ablation by four methods, and determine the primary outcome that most reflects procedure success. DESIGN: Descriptive cohort study (Canadian Task Force classification II-2). SETTING: Minimal-access gynecologic surgery unit in northeast England. PATIENTS: One hundred thirty-nine women. INTERVENTION: Endometrial ablation by one of four methods: Cavaterm, endometrial laser interstitial thermotherapy (ELITT), endometrial laser ablation (ELA), or NovaSure impedance-controlled system. MEASUREMENTS AND MAIN RESULTS: Clinical outcomes were assessed according to menstrual outcome. Whereas amenorrhea rates were significantly different among the four techniques (chi2 = 9.42, p = 0.02), combined amenorrhea and hypomenorrhea rates were not significantly different (67%, 69%, 69%, 62%, chi2 = 0.38, NS) for Cavaterm, ELITT, ELA, and NovaSure, respectively. Quality of life, measured preoperatively by the EQ-5D index and EQ-5D vas, SF-12 physical and mental component scores, and sexual activity questionnaire pleasure, habit, and discomfort scores, were substantially improved 12 months after treatment. No significant differences were seen in quality of life scores between women after endometrial ablation and the general population. CONCLUSION: Quality of life for women with menorrhagia is improved to a normal level by treatment with either first- or second-generation endometrial ablation.

Cohort Studies↗
PubMed2003

In-vitro and in-vivo histochemical and thermal studies using a thermal balloon endometrial ablation system for varying treatment times.

BACKGROUND: To assess the immediate zone of thermal necrosis (ZTN) using an enzyme histochemical staining technique and serosal temperatures for the Cavaterm endometrial balloon ablation system for different treatment times. METHODS: A thermal balloon ablation was performed initially post- (n = 6) and subsequently pre-hysterectomy (n = 15). Eight to 12 tissue blocks from each uterus were sectioned and stained using diaphorase respiratory enzyme techniques. Patients in the in-vivo group had temperature measurements taken from four serosal points, a myometrial gradient profile, the balloon surface and the endocervical canal. RESULTS: The serosal temperature sensors did not demonstrate any rise in temperature above 44.1 degrees C. The mean temperature at the anterior wall, posterior wall, fundus and cornual areas was 37.1 (SD 1.3), 36.8 (SD 1.0), 37.4 (SD 1.8) and 36.7 degrees C (SD 1.0), respectively. The immediate mean maximum ZTN was greatest for the 15-min treatment time (3.1 mm, SD 1.5) compared to the 10- and 7-min treatment times (3.0 mm, SD 1.4 and 2.2 mm, SD 0.7, respectively). The maximum ZTN recorded was 5.6 mm. No full thickness injuries were demonstrated either histochemically or suggested by the temperature studies. CONCLUSIONS: This study confirms that Cavaterm thermal balloon ablation produces a reproducible thermal injury without evidence of serosal heating. Results suggest that the treatment time could be reduced to 10-min with no detrimental effect on the clinical outcomes. This hypothesis is currently being evaluated by clinical trials.

Female↗
PubMed2003

A randomised controlled trial comparing the Cavaterm endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding.

OBJECTIVE: To compare the effectiveness of the Cavaterm thermal balloon endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding. DESIGN: Randomised controlled trial. SETTING: Minimal access gynaecological surgery unit in a district general hospital. POPULATION: Seventy-two women with dysfunctional uterine bleeding requesting conservative surgical management of their condition. METHODS: Women with a normal endometrial biopsy and normal uterine cavity were randomly allocated to endometrial ablation by Cavaterm or Nd:YAG laser. Patients completed pre-operative and 6- and 12-month post-operative questionnaires assessing menstrual symptoms, quality of life, sexual activity and procedural satisfaction and acceptability. All patients received a single dose of gonadotropin-releasing hormone analogue one month pre-operatively and kept blinded to the procedure performed until after the 6-month assessment. MAIN OUTCOME MEASURES: The primary outcome measure was amenorrhoea rate. Secondary outcomes were effect on blood loss, quality of life, sexual activity, patient satisfaction and procedure acceptability. RESULTS: Seventy-two women were randomised. Amenorrhoea rates at 12 months in the Cavaterm and endometrial laser ablation groups were 29% vs 39% (P = 0.286), with combined amenorrhoea and hypomenorrhoea rates of 73% vs 69%, respectively. At 12 months, repeat surgery rates were higher in the endometrial laser ablation group (15% vs 12%, P = 0.395). Cavaterm was an acceptable procedure and 93% of patients satisfied or very satisfied at 12 months (95% endometrial laser ablation). Both treatments were associated with an increase from baseline in the SF-12 physical score (Cavaterm mean difference -3.9, 95% CI -7.9, 0.2, ns; endometrial laser ablation mean difference -5.1, 95% CI -9.5, -0.7, P = 0.003) and mental health score (Cavaterm mean difference -5.6, 95% CI -9.9, -1.3, P = 0.001; endometrial laser ablation mean difference -5.9, 95% CI -11.7, -0.2, P = 0.04). Patient's own assessment of health (EQ-5D VAS) improved from baseline in both groups (Cavaterm mean difference -7.6, 95% CI -13.9, -1.3, P = 0.02; endometrial laser ablation mean difference -5.4, 95% CI -14.9, 4.2, ns). EQ-5D index scores also improved (Cavaterm mean difference -0.06, 95% CI -0.2, 0.005, ns; endometrial laser ablation mean difference -0.17, 95% CI -0.3, -0.02, P = 0.02). There were no major complications in either group. CONCLUSIONS: The results with the Cavaterm thermal balloon endometrial ablation system are as good as those obtained with the Nd:YAG laser when used for the treatment of dysfunctional uterine bleeding in the short term. It results in a significant reduction in menstrual blood loss, patient satisfaction and improvement in patient quality of life. Larger studies with longer follow up are required to determine its place in the modern treatment of dysfunctional uterine bleeding.

Adult↗