RESUMO
BACKGROUND: Endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain. METHODS: We plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons' preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants' preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at 12 months. Assuming a standard deviation of 22 points around the pain score, 90% power, 5% significance and 20% missing data, 400 participants are required to be randomised to detect an 8-point pain score difference. DISCUSSION: This trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE. TRIAL REGISTRATION: ISRCTN registry ISRCTN27244948. Registered 6 April 2021.
Assuntos
Dor Crônica , Endometriose , Laparoscopia , Feminino , Humanos , Dor Crônica/diagnóstico , Dor Crônica/etiologia , Dor Crônica/cirurgia , Endometriose/complicações , Endometriose/diagnóstico , Endometriose/cirurgia , Laparoscopia/métodos , Estudos Multicêntricos como Assunto , Dor Pélvica/diagnóstico , Dor Pélvica/etiologia , Dor Pélvica/cirurgia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Medicina EstatalRESUMO
A 52-year-old woman with a background of vaginal hysterectomy for heavy menstrual bleeding underwent an elective laparoscopic adhesiolysis, left salpingo-oophorectomy for left-sided pelvic pain, and a right salpingectomy. Despite a grossly normal appearance, histology revealed a rare presentation of mature teratoma with insular carcinoid tumour arising from the left fallopian tube. Even though the salpingectomy was thought to be curative, the patient underwent a second operation to remove her remaining right ovary as a precaution against malignant spread. In light of limited information in such rare cases, counselling on best management and discussion of risks to guide patient decision making remains challenging.
Assuntos
Tumor Carcinoide/diagnóstico , Tubas Uterinas/patologia , Neoplasias Ovarianas/diagnóstico , Teratoma/diagnóstico , Tumor Carcinoide/patologia , Tumor Carcinoide/cirurgia , Feminino , Humanos , Histerectomia , Laparoscopia , Pessoa de Meia-Idade , Neoplasias Ovarianas/patologia , Neoplasias Ovarianas/cirurgia , Dor Pélvica/etiologia , Cuidados Pré-Operatórios , Salpingo-Ooforectomia , Teratoma/patologia , Teratoma/cirurgia , Resultado do TratamentoRESUMO
Background: Surgical procedures are complex and susceptible to human error. Individual surgical skill correlates with improved patient outcomes demonstrating that surgical proficiency is vitally important for patient safety. Evidence demonstrates that simulation training improves laparoscopic surgical skills; however, projects to implement and integrate laparoscopic simulation into core surgical curricula have had varied success. One barrier to successful implementation has been the lack of awareness and prioritisation of simulation initiatives by key stakeholders. Objective: To determine the knowledge and perceptions of patients and hospital managers on laparoscopic surgery and simulation training in patient safety and healthcare. Method: A qualitative study was conducted in the Southwest of England. 40 semistructured interviews were undertaken with patients attending general gynaecology clinics and general surgical and gynaecology hospital managers. Results: Six key themes identified included: positive expectations of laparoscopic surgery; perceptions of problems and financial implications of laparoscopic surgery; lack of awareness of difficulties with surgical training; desire for laparoscopic simulation training and competency testing for patient benefit; conflicting priorities of laparoscopic simulation in healthcare; and drawbacks of surgical simulation training. Patients and managers were largely unaware of the risks of laparoscopic surgery and challenges for training. Managers highlighted conflicting financial priorities when purchasing educational equipment. Patients stated that they would have greater confidence in a surgeon who had undertaken mandatory surgical simulation training and perceived purchasing simulation equipment to be a high priority in the National Health Services. Most patients and hospital managers believed trainees should pass an examination on a simulator prior to live operating. Conclusions: Competency-based mandatory laparoscopic simulation was strongly supported by the majority of stakeholders to augment the initial learning curve of surgeons.