Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: study protocol for a randomised controlled feasibility trial (ESPriT1).

BACKGROUND: Endometriosis (where endometrial-like tissue is found outside the uterus) affects ~ 176 million women worldwide and can lead to debilitating pelvic pain. Three subtypes of endometriosis exist, with ~ 80% of women having superficial peritoneal endometriosis (SPE). Endometriosis is diagnosed by laparoscopy and, if SPE is found, gynaecologists usually remove it surgically. However, many women get limited pain relief from surgical removal of SPE. We plan to undertake a future large trial where women who have only SPE found at initial laparoscopy are randomly allocated to have surgical removal (excision or ablation) of SPE, or not. Ultimately, we want to determine whether surgical removal improves overall symptoms and quality of life, or whether surgery is of no benefit, exacerbates symptoms, or even causes harm. The primary objective of this feasibility study is to determine what proportion of women with suspected SPE undergoing diagnostic laparoscopy will agree to randomisation. The secondary objectives are to determine if there are differences in key prognostic parameters between eligible women that agree to be randomised and those that decline; how many women having laparoscopy for investigation of chronic pelvic pain are eligible for the trial; the range of treatment effects and variability in outcomes and the most acceptable methods of recruitment, randomisation and assessment tools. METHODS: We will recruit up to 90 women with suspected SPE undergoing diagnostic laparoscopy over a 9-month recruitment period in four Scottish hospitals and randomise them 1:1 to either diagnostic laparoscopy alone (with a sham port to achieve blinding of the allocation) or surgical removal of endometriosis. Baseline characteristics, e.g. age, index of social deprivation, ethnicity, and intensity/duration of pain will be collected. Participants will be followed up by online questionnaires assessing pain, physical and emotional function at baseline, 3 months, 6 months and 12 months. DISCUSSION: Recruitment to a randomised controlled trial to assess the effectiveness of surgery for endometriosis may be challenging because of preconceived ideas about treatment success amongst patients and clinicians. We have designed this study to assess feasibility of recruitment and to inform the design of our future definitive trial. TRIAL REGISTRATION: ClincicalTrials.gov, NCT04081532 STATUS: Recruiting.

Development and use of a restructured animal tissue model for training in laparoscopic salpingostomy and salpingectomy.

Ectopic pregnancy is commonly managed via either laparoscopic salpingostomy or salpingectomy. However, there is a proficiency gain curve in mastering these 2 surgical procedures, and an effective simulated model is essential for training students of gynecology. The objective of this study was to develop and evaluate a restructured animal tissue model that can be used in the surgical training of gynecologists in laparoscopic salpingostomy and salpingectomy. Since 2005, a hands-on laparoscopic training course for gynecologic students has been developed and conducted at the Cushieri Skills Centre, University of Dundee. A restructured animal tissue model of ectopic pregnancy was developed and used for practicing laparoscopic salpingostomy and salpingectomy. At the end of each course, data were collected using a standardized anonymous questionnaire using a Likert scale (1= strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; and 5 = strongly agree). Feedback on the ectopic pregnancy model from course participants was obtained insofar as the realism of the anatomical condition of the model, quality of the tissue and organ color, quality of organ consistency, and operative tactile properties during dissection. Over the last 6 years, from June 2005 to September 2010, 96 gynecologic trainees have practiced using this phantom. The mean (SD) overall satisfaction rate for the training phantom for laparoscopic salpingostomy and salpingectomy was 4.9 (0.1) on a scale of 1(unrealistic/poor) to 5 (very realistic/useful). Compared with real operating conditions, quality assessment of the model for anatomical condition was 4.9 (0.2), for quality of tissue and organ color was 4.9 (0.4), for organ consistency was 4.8 (0.3), and for operative tactility was 4.8 (0.6). It was concluded that the restructured animal tissue model of laparoscopic salpingostomy and salpingectomy in ectopic pregnancy is realistic, cost-effective, and simple enough to be produced for use in laboratory-based surgical training courses.

Diagnostic dilemma posed by severe pelvic actinomycosis associated with prolonged use of copper intrauterine contraceptive device.

Actinomycosis has been recognized to be associated with the use of intrauterine contraceptive device. We are reporting a case where a patient with severe pelvic actinomycosis presented with the clinical picture of an ovarian tumour. A 44-year-old lady attended the A&E with progressively worsening lower abdominal pain. A computerized tomography (CT) scan showed the presence of a large pelvic mass, right hydronephrosis and prominent para-aortic lymph nodes and an elevated C-reactive proteine (CRP) and white cell count (WCC). When there was no improvement with antibiotic therapy, a laparotomy was performed, where bilateral tubo-ovarian abscess and dense adhesions were found. A subtotal hysterectomy, bilateral salpingoophorectomy and small bowel resection was performed. Histopathology of the specimen confirmed the diagnosis of actinomycosis. The case highlighted the diagnostic dilemma for ascertaining the nature of the pelvic mass in this patient. Due to its invasion of surrounding tissues and the formation of masses severe infection is often confused with an ovarian neoplasm.

Comparison of laparoscopic and abdominal hysterectomy in terms of quality of life: a systematic review.

The objective of this study was to investigate the randomized studies reporting on quality of life after laparoscopic hysterectomy as compared to abdominal hysterectomy. A systematic qualitative review was performed on published studies identified by the databases PubMed and EMBASE, as well as cross-references. Randomized clinical trials on laparoscopic versus abdominal hysterectomy were assessed for the methods in which studies reported on postoperative health or quality of life as an outcome measure. Study results were described qualitatively. Thirty papers, published between 1994 and 2004, were identified. Only seven studies, incorporating data on 1450 patients, reported on postoperative health or quality of life. Four of these studies used eight different validated quality of life questionnaires. Two of these four studies reported significant differences between the treatment groups, with better quality of life in the first 6 weeks after laparoscopic hysterectomy when compared to the abdominal approach. Although, the main reason for performing a laparoscopic hysterectomy instead of an abdominal hysterectomy is the improvement of quality of life, only a few studies have used this as an outcome measure. The data available show that laparoscopic hysterectomy performs equally or better in terms of postoperative health and quality of life in the first weeks after surgery. In the decision for an approach to hysterectomy, the advantage of better quality of life should be offset against the increased risk of complications in laparoscopic hysterectomy.

Health technology assessment of surgical therapies for benign gynaecological disease.

This chapter summarises the evidence of the benefits and harm of surgical therapies for benign gynaecological disease. We have limited the discussion in this chapter to three gynaecological conditions - menorrhagia, endometriosis and benign ovarian tumours - with a further section on the different surgical approaches for performing a hysterectomy for menorrhagia due to dysfunctional uterine bleeding and pelvic masses such as fibroids and benign adnexal masses. The currently available evidence suggests that there is little to choose between the four first-generation endometrial destruction techniques - laser ablation, transcervical resection of endometrium, vaporisation ablation and rollerball ablation - in terms of clinical efficacy and patient satisfaction. There is a paucity of evidence with regards to the comparison of the different second-generation endometrial-destruction techniques but current evidence suggests that bipolar radiofrequency ablation is more effective than thermal balloon ablation for treating menorrhagia. Overall, the second-generation techniques are at least as effective as first-generation methods but are easier to perform and can be done under local rather than general anaesthesia in some circumstances. Hysteroscopic endometrial ablation is an alternative to hysterectomy and should be offered to women with menorrhagia because of its high satisfaction rates, shorter operation time, shorter hospital stay, earlier recovery and reduced postoperative complications; hysterectomy remains the surgical option of choice for women with intractable menorrhagia despite repeated endometrial ablations and for those who do not wish under any circumstances to continue to have menstrual bleeding. The combined use of laparoscopic laser ablation, adhesiolysis and uterine nerve ablation has been shown to have a beneficial effect on pelvic pain associated with mild to moderate endometriosis. Current evidence also supports the use of laparoscopic treatment of minimal and mild endometriosis to improve the on-going pregnancy and live birth rate in infertile patients. The current available evidence suggests that the laparoscopic approach is superior to laparotomy for the surgical management of benign ovarian cysts. It results in less postoperative pain and a shorter postoperative hospital stay; it also costs less. With regards to the surgical approach for performing a hysterectomy for menorrhagia and benign pelvic masses, vaginal hysterectomy should be performed over laparoscopic and abdominal hysterectomy when possible. Where it is not possible to perform the hysterectomy vaginally, then laparoscopic hysterectomy can be employed instead of abdominal hysterectomy to avoid a laparotomy scar. There appears to be no significant advantage in performing a subtotal hysterectomy instead of the total removal of the uterine corpus and cervix.

Ultrasonographic endometrial thickness for diagnosing endometrial pathology in women with postmenopausal bleeding: a meta-analysis.

Our aim was to determine the diagnostic accuracy of endometrial thickness measurement by pelvic ultrasonography for predicting endometrial carcinoma and disease (hyperplasia and/or carcinoma) during an investigation of postmenopausal bleeding. We performed a systematic quantitative review of the available published literature, which consisted of online searching the MEDLINE and EMBASE databases (1966-2000) coupled with scanning of bibliography of known primary and review articles. The selection of studies, assessment of study quality, and extraction of data were performed in duplicate under masked conditions. Included in the analyses were 57 studies with 9031 patients. Accuracy data were summarized using likelihood ratios for various cut-off levels of abnormal endometrial thickness. The commonest cut-offs were 4 mm (9 studies) and 5 mm (21 studies), measuring both endometrial layers. None of the nine studies using the < or = 4 mm cut-off level were of good quality. Only four studies (out of the 21) used the < or = 5 mm cut-off level, which employed the best-quality criteria. Using the pooled estimates from these four studies only, a positive test result raised the probability of carcinoma from 14.0% (95% CI 13.3-14.7) to 31.3% (95% CI 26.1-36.3), while a negative test reduced it to 2.5% (95% CI 0.9-6.4). In conclusion, ultrasound measurement of endometrial thickness alone, using the best-quality studies cannot be used to accurately rule. However, a negative result at < or = 5 mm cut-off level measuring both endometrial layers in the presence of endometrial pathology rules out endometrial pathology with good certainty.