Development of a core outcome set and outcome definitions for studies on uterus-sparing treatments of adenomyosis (COSAR): an international multistakeholder-modified Delphi consensus study.

STUDY QUESTION: What outcomes should be reported in all studies investigating uterus-sparing interventions for treating uterine adenomyosis? SUMMARY ANSWER: We identified 24 specific and 26 generic core outcomes in nine domains. WHAT IS KNOWN ALREADY: Research reporting adenomyosis treatment is not patient-centred and shows wide variation in outcome selection, definition, reporting and measurement of quality. STUDY DESIGN, SIZE, DURATION: An international consensus development process was performed between March and December 2021. Participants in round one were 150 healthcare professionals, 17 researchers and 334 individuals or partners with lived experience of adenomyosis from 48 high-, middle- and low-income countries. There were 291 participants in the second round. PARTICIPANTS/MATERIALS, SETTING, METHODS: Stakeholders included active researchers in the field, healthcare professionals involved in diagnosis and treatment, and people and their partners with lived experience of adenomyosis. The core component of the process was a 2-step modified Delphi electronic survey. The Steering Committee analysed the results and created the final core outcome set (COS) in a semi-structured meeting. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 241 outcomes was identified and distilled into a 'long list' of 71 potential outcomes. The final COS comprises 24 specific and 26 generic core outcomes across nine domains, including pain, uterine bleeding, reproductive outcomes, haematology, urinary system, life impact, delivery of care, adverse events and reporting items, all with definitions provided by the Steering Committee. Nineteen of these outcomes will apply only to certain study types. Although not included in the COS, the Steering Committee recommended that three health economic outcomes should be recorded. LIMITATIONS, REASONS FOR CAUTION: Patients from continents other than Europe were under-represented in this survey. A lack of translation of the survey might have limited the active participation of people in non-English speaking countries. Only 58% of participants returned to round two, but analysis did not indicate attrition bias. There is a significant lack of scientific evidence regarding which symptoms are caused by adenomyosis and when they are related to other co-existent disorders such as endometriosis. As future research provides more clarity, the appropriate review and revision of the COS will be necessary. WIDER IMPLICATIONS OF THE FINDINGS: Implementing this COS in future studies on the treatment of adenomyosis will improve the quality of reporting and aid evidence synthesis. STUDY FUNDING/COMPETING INTEREST(S): No specific funding was received for this work. T.T. received a grant (grant number 2020083) from the South Eastern Norwegian Health Authority during the course of this work. T.T. receives personal fees from General Electrics and Medtronic for lectures on ultrasound. E.R.L. is the chairman of the Norwegian Endometriosis Association. M.G.M. is a consultant for Abbvie Inc and Myovant, receives research funding from AbbVie and is Chair of the Women's Health Research Collaborative. S.-W.G. is a board member of the Asian Society of Endometriosis and Adenomyosis, on the scientific advisory board of the endometriosis foundation of America, previous congress chair for the World Endometriosis Society, for none of which he received personal fees. E.S. received outside of this work grants for two multicentre trials on endometriosis from the National Institute for Health Research UK, the Rosetrees Trust, and the Barts and the London Charity, he is a member of the Medicines and Healthcare Products Regulatory Agency (MHRA), Medicines for Women's Health Expert Advisory Group, he is an ambassador for the World Endometriosis Society, and he received personal fees for lectures from Hologic, Olympus, Medtronic, Johnson & Johnson, Intuitive and Karl Storz. M.H. is member of the British Society for Gynaecological Endoscopy subcommittee. No other conflict of interest was declared. TRIAL REGISTRATION NUMBER: N/A.

Hysteroscopic sterilization: 10-year retrospective analysis of worldwide pregnancy reports.

STUDY OBJECTIVE: To identify factors that might contribute to pregnancies reported after hysteroscopic sterilization worldwide. DESIGN: Retrospective review of commercial data compiled from the MAUDE database, medical literature, and manufacturer reports received during commercial distribution of hysteroscopic sterilization micro-inserts from 2001 through 2010 (Canadian Taskforce classification III descriptive study). MEASUREMENTS AND MAIN RESULTS: From 2001 through 2010, 497 305 hysteroscopic sterilization kits were distributed worldwide, and 748 pregnancies were reported, i.e., 0.15% of the estimated user population based on the number of distributed kits. The data were sufficient to enable analysis of 508 pregnancies for potential contributing factors and showed most to be associated with patient or physician noncompliance (n = 264) or misinterpreted confirmation tests (n = 212). Conceptions deemed to have occurred within 2 weeks of the procedure and therefore too early for detection were identified in 32 cases. CONCLUSION: Although there are limitations to the dataset and the study design is retrospective, it represents the largest body of cumulative hysteroscopic sterilization data available to date. Of the 748 pregnancies reported, it is apparent that some might have been prevented with greater patient and clinician attention to interim contraceptive use and counseling and with more rigorous evaluation and informed interpretation of the procedure confirmation tests. Although the estimated pregnancy rate based on such a dataset is likely an underestimation, it does suggest that the evaluable field performance of hysteroscopic sterilization micro-inserts is consistent with the labeled age-adjusted effectiveness of 99.74% at 5 years.

Supracervical hysterectomy: ... a time for reappraisal.

Supracervical or subtotal hysterectomy is a procedure that largely was discarded in the middle part of this century. This decision was made because of the reduction in morbidity and mortality associated with total hysterectomy, the only known and available method for the prevention of cervical cancer. This rationale, appropriate earlier in the century, has become somewhat undermined with the advent of Papanicolaou smear screening, colposcopic diagnosis, and simple outpatient therapy for preinvasive cervical neoplasia. Furthermore, some have argued that supracervical hysterectomy better preserves bladder and sexual function, and may be associated with reduced surgical and postoperative morbidity. Recently, laparoscopic supracervical hysterectomy has been introduced as another operative alternative with putative advantages over the procedure performed via laparotomy. However, for routine cases, the available literature does not confirm that one procedure is superior, regardless of the route of access. In selected cases, where benign conditions significantly distort the cervical anatomy complicating the dissection, supracervical hysterectomy would seem a prudent choice. It is clear that appropriately designed comparative studies are in order, to better determine the place for supracervical hysterectomy in the contemporary management of women with benign uterine disease.

A classification system for laparoscopic hysterectomy.

The term "laparoscopic hysterectomy" has been applied to a variety of procedures, ranging from lysis of adhesions laparoscopically followed by vaginal hysterectomy, to removal of the entire uterus under endoscopic direction. These procedures vary in a number of ways, including cost, morbidity, operating time, and surgical skill required. To facilitate training, credentialing, and outcome evaluation, we present the following classification system: type I--division of one or both pedicles containing the ovarian arteries, type II--dissection including one or both uterine arteries, type III--type II plus separation of part of at least one cardinal-uterosacral ligament complex, and type IV--type II plus separation of the entire cardinal-uterosacral ligament complex on at least one side. Each of the types may be subclassified according to the degree of dissection of structures located anterior and posterior to the cervix. Supracervical hysterectomy has a separate system of classification. Operations are categorized by management of the ovarian and uterine arteries and subdivided according to treatment of the cervical canal.

Incisional hernia following laparoscopy: a survey of the American Association of Gynecologic Laparoscopists.

OBJECTIVE: To estimate the risk factors for and incidence of post-laparoscopy incisional hernia. METHODS: A questionnaire was sent to all individuals on a mailing list from the American Association of Gynecologic Laparoscopists. Adequately completed responses were entered into a computer-based data bank for analysis. Of the 11,500 surveys mailed, 3293 were returned; of these, 3217 were evaluable. RESULTS: A total of 933 hernias was reported from an estimated 4,385,000 laparoscopic procedures (an incidence of 21 per 100,000); 167 (17.9%) were reported to have occurred despite fascial closure. Six hundred sixty-five patients (71:3%) had subsequent surgical repair. Seven hundred twenty-five (86.3%) of the 840 hernias in which the size of the original fascial defect was noted, occurred in sites where ports 10 mm in diameter or larger had been placed. The occurrence of hernias is a function of the number of laparoscopies performed (P < .0001) and is not related to the length of the surgeon's career (P = .41). In at least 157 instances (16.8%), the presenting symptom or morbidity of the hernia was directly related to the involvement of the large or small intestine. CONCLUSION: Post-laparoscopy incisional hernias occur at an approximate incidence of 21 per 100,000 and are associated with significant morbidity. These hernias are most likely to occur when large ports are used. As currently practiced, closure is not completely protective. Further methods or devices should be developed to minimize the risk of hernia formation.

Entry force and intra-abdominal pressure associated with six laparoscopic trocar-cannula systems: a randomized comparison.

OBJECTIVE: In trocar-cannula systems, increased entry force could result in loss of operator control, a potential cause of serious visceral and vascular injuries. We developed a system to measure entry force and intraperitoneal pressure to evaluate and compare trocar-cannula systems. METHODS: Six laparoscopic trocar-cannula systems of similar diameter (12 mm) were tested (two pyramidal, two cutting-dilating, and two blunt conical) using a white swine model. All six systems were inserted into each of 12 subjects with location designated by random allotment (72 insertions). During each insertion, intraperitoneal pressure and entry force were measured using a system consisting of a gas-gas transducer, a 50-lb load cell, and a multichannel data acquisition board. Mean entry force and intraperitoneal pressure were compared using mixed-model analysis of variance. RESULTS: Mean entry force measurements were as follows: pyramidal 9.01 lb and 13.48 lb, cutting-dilating 9.94 lb and 16.46 lb, and blunt conical 19.15 lb and 31.91 lb. Intraperitoneal pressure changes generally reflected measured entry force. CONCLUSION: The system successfully measured both entry force and resultant intraperitoneal pressure. Pyramidal trocar-cannula systems required the lowest force for entry. These differences in entry force have potential clinical implications related to the risk of visceral and vascular injury. Intraperitoneal pressure measurement could be used as a surrogate for insertional force measurement.

Incision characteristics associated with six laparoscopic trocar-cannula systems: a randomized, observer-blinded comparison.

OBJECTIVE: Laparoscopic trocar-cannula systems of different design but similar internal diameter result in incisions of varying dimensions. Such variations might affect the incidence of incisional complications, such as dehiscence and hernia. We developed a system to measure associated fascial defects and then used the techniques to compare the defects resulting from different trocar-cannula systems. METHODS: This was a randomized, observer-blinded study. Six laparoscopic trocar-cannula systems of similar diameter (12 mm) were tested (two pyramidal, two blunt conical, and two cutting-dilating) using a white swine model. All systems were inserted into each of 12 subjects, with location designated by random allotment (total 72 insertions). The fascial defects were exposed and then directly measured for incisional length and area by an observer blinded to the system used. Means of each outcome variable (incisional length and area) were compared using factorial analysis of variance. RESULTS: The values for mean incisional areas were as follows: cutting-dilating 28.73 mm2 and 31.09 mm2, pyramidal 18.25 mm2 and 26.75 mm2, and blunt conical 10.00 mm2 and 12.33 mm2. Mean maximal incisional lengths were similar among all trocar-cannula systems. CONCLUSION: Blunt conical trocar-cannula systems resulted in significantly smaller fascial defects compared with the widely used pyramidal and the two cutting-dilating trocar-cannula systems tested. These differences have potential clinical implications. For example, smaller fascial defects could reduce risk of incisional hernia and dehiscence.

Successful pregnancy following zygote intrafallopian transfer for congenital cervical hypoplasia.

BACKGROUND: Congenital cervical atresia and hypoplasia are rare abnormalities that generally require reconstructive or extirpative procedures to relieve outflow tract obstruction. Infertility is a common sequel, and only four previous pregnancies have been reported. In selected cases, zygote intrafallopian transfer (ZIFT) or other assisted reproductive techniques may offer alternatives for conception. CASE: A 21-year-old amenorrheic woman experienced a spontaneous gush of vaginal bleeding following an 11-year history of cyclic lower abdominal pain. Regular but prolonged and painful menses ensued. After another 8 years of primary infertility, transcervical and transfundal hysteroscopy demonstrated congenital cervical hypoplasia and a normal endometrial cavity. Conception was achieved during her third cycle of ZIFT. Delivery occurred by elective cesarean at 39 weeks for a persistent oblique fetal lie. CONCLUSION: A successful pregnancy was established following ZIFT in a woman with congenital cervical hypoplasia. The endometrial cavity was evaluated by a previously unreported technique, transfundal hysteroscopy. The use of appropriate surgical or assisted reproductive techniques in conjunction with individualized post-conception management may permit successful pregnancy and delivery in selected women with congenital cervical hypoplasia and atresia.

Evaluation of fetal monitoring by telemetry.

A radiotelemetry system for the direct monitoring of fetal heart rate and intrauterine pressure during labor has been evaluated at 5 different institutions. A conventional fetal scalp electrode and a special intrauterine pressure sensor are connected to a radio transmitter placed on the patient's thigh. The receiver can be located up to 50 feet away from the transmitter and is either a self-contained monitor or a unit that converts a conventional fetal monitor to a telemetric one. The telemetry recordings are of similar quality to those obtained from conventional monitors. Telemetry allows for greater patient comfort and mobility as well as greater convenience to the clinical staff. Continuous data can be obtained from patients while they are ambulatory or sitting in a chair as well as while they are in bed.

Medical management of abnormal uterine bleeding.

Abnormal uterine bleeding occurs secondary to a wide variety of functional and structural abnormalities. Although there is clearly a place for surgery, medical therapy has enormous potential for most women, especially those with dysfunctional uterine bleeding. To provide women with appropriate options for therapy, the clinician must be prepared to distinguish abnormal bleeding that is associated with ovulation from that which is anovulatory and to use appropriate ancillary tests to identify structural and endocrinologic anomalies or lifestyle factors that may explain the bleeding. In undertaking such an investigation, it is important for the clinician to be able to distinguish lesions that may be asymptomatic and unrelated to the bleeding from those that truly are the source of the problem. With this information, a rationally determined set of medical and, if appropriate, surgical therapeutic options may be presented to the woman. Among these medical treatment options are a number of treatment options that have not seen widespread use in North America but are inexpensive, effective, and well tolerated. It is clear that medical therapy is not for everyone. Women deserve the opportunity to relieve their symptoms with nonsurgical options.

Loop electrosurgical excision in the peritoneal cavity. Preliminary experience with the rat model.

OBJECTIVE: To evaluate a monopolar electrosurgical loop electrode designed for use at laparoscopy. STUDY DESIGN: A pilot, observational study of cutting effectiveness followed by a nonrandomized comparative study of thermal injury associated with the loop electrode and CO2 vaporization in the rat model. The observer evaluating thermal injury was blind to the energy source used. RESULTS: The loops cut most effectively with a continuous, sinusoidal, radiofrequency output at 40 W. The depth of coagulative necrosis was similar in the laser vaporization and loop excision groups of lesions when using outputs and power densities commonly attainable at laparoscopy. There was more necrotic debris in the lasered lesions. CONCLUSION: While a randomized comparison will be necessary to clarify these results, electrosurgical loop electrodes seem to have a role in a number of gynecologic laparoscopic procedures.

Giant hydrosalpinx.

A rare case of giant hydrosalpinx is presented, together with a review of the English literature on the subject. The pathology and pathophysiology of hydrosalpinx are reviewed.

Can we achieve international agreement on terminologies and definitions used to describe abnormalities of menstrual bleeding?

BACKGROUND: There is considerable worldwide confusion in the use of terminologies and definitions around the symptom of abnormal uterine bleeding (AUB), and these are leading increasingly to difficulties in setting up multinational clinical trials and in interpreting the results of studies undertaken in single centres. An international initiative was established to develop an agreement process to recommend clear, simple terminologies and definitions with the potential for wide acceptance. METHODS: After widespread consultation with relevant international and national organizations, journal editors and individuals, a modified Delphi process was developed to assess the current use of terminologies followed by a structured face-to-face meeting of 35 clinicians (mostly gynaecologists) and scientists in Washington. Focused small group discussions led to plenary assessment of concepts and recommendations using an electronic keypad voting system. RESULTS: There was almost universal agreement that poorly defined terms of classical origin used in differing ways in the English medical language should be discarded and that these should be replaced by simple, descriptive terms with clear definitions which have the potential to be understood by health professional and patient alike and which can be translated into most languages. The major recommendations were to replace terms such as menorrhagia, metrorrhagia, hypermenorrhoea and dysfunctional uterine bleeding. Suggestions for potentially suitable replacement terms and definitions are made. CONCLUSIONS: A simple terminology has been recommended for the description and definition of symptoms and signs of AUB. This manuscript should be a living document and should be part of an ongoing process with international medical and community debate. Classification of causes, investigations and cultural and quality of life issues should be part of the ongoing process.

Automated laparoscope positioner: preliminary experience.

A new automated laparoscope positioner was designed that is easy to use and provides the surgeon with an opportunity to perform most laparoscopically directed procedures efficiently and safely without the need for an assistant. Potential additional benefits are reduced cost of care, development of laparoscopic simulators suitable for training residents, and development of surgical procedures and devices.

Papillomaviral Infections of the Female Genital Tract: A look at the full spectrum of HPV infections.

The human papillomavirus (HPV) is the most common organism to infect the human genital tract, affecting as much as half, or more, of the sexually active population. This virus has become widely recognized through the well publicized relationship with genital tract neoplasia and through new diagnostic technologies, such as monoclonal antibody analysis, DNA hybridization, and the polymerase chain reaction. This paper describes the full spectrum of HPV infections, starting with pathogenesis and continuing to clinical manifestations, and discusses significance, diagnosis, and management.

Dysfunctional uterine bleeding: advances in diagnosis and treatment.

Dysfunctional uterine bleeding occurs during the reproductive years unrelated to structural uterine abnormalities. Ovulatory dysfunctional uterine bleeding occurs secondary to defects in local endometrial hemostasis; while anovulatory dysfunctional uterine bleeding is a systemic disorder, occurring secondary to endocrinologic, neurochemical, or pharmacologic mechanisms. Evaluation of patients with abnormal uterine bleeding and identifying those with dysfunctional uterine bleeding is achieved with a combination of the following: history; physical examination; and judicious use of laboratory evaluation, endometrial sampling and uterine imaging, with sonographic techniques and/or hysteroscopy. Coagulopathies should be considered as should the notion that intramural and subserosal myomas are unlikely to contribute to AUB. High-quality evidence suggests that medical therapy is frequently successful, and newer approaches, such as local delivery of progestins via intrauterine devices, appear to be particularly promising and devoid of systemic side effects. For those intolerant of medical therapy, and/or for whom fertility is no longer desired, a number of minimally invasive surgical options for hysterectomy now exist and are collectively termed endometrial ablation. Endometrial ablation may be performed with or without hysteroscopic guidance. There is an increasing body of evidence that suggests that nonhysteroscopic endometrial ablation may be at least as effective as hysteroscopic endometrial ablation, even when the hysteroscopic procedure is performed by experts.