Abortion in the First Trimester. Guideline of the DGGG (S2k-Level, AWMF Registry No. 015-094, December 2022) - Part 2 with Recommendations for Surgical Termination of Pregnancy and Follow-up Care After Termination of Pregnancy.

Purpose The aim was to develop evidence-based recommendations where possible. The guideline presents the medical principles and scientific evidence for indications, counselling of affected persons, performing terminations, the choice of method, and the care and monitoring of a terminated pregnancy up until week 12 + 0 of gestation p. c. Methods In accordance with the requirements for an S2k-guideline, the contents of the guideline were drafted following a systematic search of the literature by a representative interdisciplinary group of experts. Guideline authors held several formal meetings under the auspices of the German Society for Gynaecology and Obstetrics (DGGG) during which the contents of the guideline were finalised and agreed upon. Recommendations The guideline provides recommendations on the surgical termination of pregnancy and follow-up care after termination of pregnancy.

Abortion in the First Trimester. Guideline of the DGGG (S2k-Level, AWMF Registry No. 015-094, December 2022) - Part 1 with Recommendations on Care Structures, Information and Advice on Decision-Making, Measures Before Abortion and Medical Abortion.

Purpose The aim was to develop evidence-based recommendations where possible. The guideline presents the medical principles and scientific evidence for indications, the counselling of affected women, performing terminations, the choice of method, and the care and monitoring of a terminated pregnancy up until week 12 + 0 of gestation p. c. Methods In accordance with the requirements for S2k-guidelines, the contents of the guideline were drafted following a systematic search of the literature by a representative interdisciplinary group of experts. Guideline authors held several formal meetings under the auspices of the German Society for Gynaecology and Obstetrics (DGGG) during which the contents of the guideline were finalised and agreed upon. Recommendations A total of 61 recommendations are provided, covering care structures, provision of information and counselling to support decision-making, the measures to be taken before terminating the pregnancy, and medical termination of the pregnancy.

Rates of severe complications in patients undergoing colorectal surgery for deep endometriosis-a retrospective multicenter observational study.

INTRODUCTION: Surgical experience and hospital procedure volumes have been associated with the risk of severe complications in expert centers for endometriosis in France. However, little is known about other certified units in Central European countries. MATERIAL AND METHODS: This retrospective observational study included 937 women who underwent surgery for colorectal endometriosis between January 2018 and January 2020 in 19 participating expert centers for endometriosis. All women underwent complete excision of colorectal endometriosis by rectal shaving, discoid or segmental resection. Postoperative severe complications were defined as grades III-IV of the Clavien-Dindo classification system including anastomotic leakage, fistula, pelvic abscess and hematoma. Surgical outcomes of centers performing less than 40 (group 1), 40-59 (group 2) and ≥60 procedures (group 3) over a period of 2 years were compared. RESULTS: The overall complication rate of grade III and IV complications was 5.1% (48/937), with rates of anastomotic leakage, fistula formation, abscess and hemorrhage in segmental resection, discoid resection and rectal shaving, respectively, as follows: anastomotic leakage 3.6% (14/387), 1.4% (3/222), 0.6% (2/328); fistula formation 1.6% (6/387), 0.5% (1/222), 0.9%; (3/328); abscess 0.5% (2/387), 0% (0/222) and 0.6% (2/328); hemorrhage 2.1% (8/387), 0.9% (2/222) and 1.5% (5/328). Higher overall complication rates were observed for segmental resection (30/387, 7.8%) than for discoid (6/222, 2.7%, P = 0.015) or shaving procedures (12/328, 3.7%, P = 0.089). No significant correlation was observed between the number of procedures performed and overall complication rates (rSpearman  = -0.115; P = 0.639) with a high variability of complications in low-volume centers (group 1). However, an intergroup comparison revealed a significantly lower overall severe complication rate in group 3 than in group 2 (2.9% vs 6.9%; P = 0.017) without significant differences between other groups. CONCLUSIONS: A high variability in complication rates does exist in centers with a low volume of activity. Major complications may decrease with an increase in the volume of activity but this effect cannot be generally applied to all institutions and settings.

The Future of Adhesion Prophylaxis Trials in Abdominal Surgery: An Expert Global Consensus.

Postoperative adhesions represent a frequent complication of abdominal surgery. Adhesions can result from infection, ischemia, and foreign body reaction, but commonly develop after any surgical procedure. The morbidity caused by adhesions affects quality of life and, therefore, it is paramount to continue to raise awareness and scientific recognition of the burden of adhesions in healthcare and clinical research. This 2021 Global Expert Consensus Group worked together to produce consented statements to guide future clinical research trials and advise regulatory authorities. It is critical to harmonize the expectations of research, to both develop and bring to market improved anti-adhesion therapies, with the ultimate, shared goal of improved patient outcomes.

Diagnosis and Therapy of Female Genital Malformations (Part 1). Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/052, May 2019).

Objectives Female genital malformations may take the form of individual entities, they may involve neighboring organs or they may occur in the context of complex syndromes. Given the anatomical structures of the vulva, vagina, uterus and adnexa, the clinical picture of malformations may vary greatly. Depending on the extent of the malformation, organs of the urinary system or associated malformations may also be involved. Methods This S2k-guideline was developed by representative members from different medical specialties and professions as part of the guidelines program of the DGGG, SGGG and OEGGG. The recommendations and statements were developed using a structured consensus process with neutral moderation and voted on. Recommendations The guideline is the first comprehensive presentation of the symptoms, diagnosis and treatment options for female genital malformations. Additional chapters on classifications and transition were included.

Diagnosis and Therapy of Female Genital Malformations (Part 2). Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/052, May 2019).

Objectives Female genital malformations may be present in the form of individual entities, they may involve neighboring organs or they may occur in the context of complex syndromes. Given the anatomical structures of the vulva, vagina, uterus and uterine appendages, the clinical picture of malformations varies greatly. Methods This S2k-guideline was developed by representative members from different medical specialties and professions as part of the guidelines program of the DGGG, SGGG and OEGGG. The recommendations and statements were developed and voted on using a structured consensus process with neutral moderation. Recommendations This guideline is the first comprehensive summary of female genital malformations from infancy to adulthood which covers clinical examinations, diagnostic workups and treatment options. Additional chapters have been included on complex urogenital malformations, vascular malformations, psychosomatic care, and tumor risk.

A new approach to avoid ovarian failure as well function-impairing adhesion formation in endometrioma infertility surgery.

PURPOSE: Deep ovarian endometriosis surgery is likely to be associated with diffuse bleeding, intraoperative ovarian tissue destruction and perioperative adhesion formation. A new surgical approach is hereby proposed to avoid the negative short-term impact of classic laparoscopic cystectomy on ovarian reserve. RESULTS: The need for intraoperative periovarian coagulation after endometrioma excision was avoided by combining the gold standard minimal-access endometrioma stripping technique with a purely plant-based medical product with high-hemostatic and antiadhesion barrier properties. CONCLUSION: Endometrioma stripping followed by the application of a polysaccharide agent could avoid ovarian failure and at same time could reduce adhesion formation, thereby preserving tubo-ovarian function in endometrioma surgery. We encourage other surgically working groups to investigate middle- and long-term effects of this combined technique.

Concept Paper on the Technique of Cryopreservation, Removal and Transplantation of Ovarian Tissue for Fertility Preservation.

The cryopreservation of ovarian tissue with subsequent transplantation of the tissue represents an established method of fertility protection for female patients who have to undergo gonadotoxic therapy. The procedure can be performed at any point in the cycle and thus generally does not lead to any delay in oncological therapy. With the aid of this procedure, more than 130 births to date worldwide have been able to be recorded. The birth rate is currently approximately 30% and it can be assumed that this will increase through the further optimisation of the cryopreservation and surgical technique. The concept paper presented here is intended to provide guidance for managing cryopreservation and transplantation of ovarian tissue to German-speaking reproductive medicine centres.

Fertility Preservation for Patients with Malignant Disease. Guideline of the DGGG, DGU and DGRM (S2k-Level, AWMF Registry No. 015/082, November 2017) - Recommendations and Statements for Girls and Women.

AIM: The aim of this official guideline published by the German Society of Gynecology and Obstetrics (DGGG) and coordinated with the German Society of Urology (DGU) and the German Society of Reproductive Medicine (DGRM) is to provide consensus-based recommendations, obtained by evaluating the relevant literature, on counseling and fertility preservation for prepubertal girls and boys as well as patients of reproductive age. Statements and recommendations for girls and women are presented below. Statements or recommendations for boys and men are not the focus of this guideline. METHODS: This S2k guideline was developed at the suggestion of the guideline commission of the DGGG, DGU and DGRM and represents the structured consensus of representative members from various professional associations (n = 40). RECOMMENDATIONS: The guideline provides recommendations on counseling and fertility preservation for women and girls which take account of the patient's personal circumstances, the planned oncologic therapy and the individual risk profile as well as the preferred approach for selected tumor entities.

Fertility protection: complications of surgery and results of removal and transplantation of ovarian tissue.

Fertility-preserving measures are becoming important for patients receiving oncological treatment. One method involves cryopreservation of ovarian tissue and transplanting it when treatment is completed. We report complications resulting from surgical and fertility medicine, and the results of procedures for the removal and transplantation of ovarian tissue carried out within the FertiProtekt network. A survey using a structured questionnaire was conducted among the FertiProtekt network centres between November 2015 and June 2016. The analysis included surgical techniques used to remove and transplant ovarian tissue, surgical complications and results. Laparoscopic removal and transplantation of ovarian tissue have a low risk of complications. Surgical complications occurred in three of the network's 1373 ovarian tissue removals (n = 1302) and transplantations (n = 71); two complications (0.2%) occurred during removal and one during transplantation. Menstruation resumed in 47 out of 58 women (81%) who underwent ovarian tissue transplantation. Hormonal activity occurred in 63.2% of transplantations with a follow-up of 6 months or over. Sixteen pregnancies occurred in 14 patients, with nine births. The risks and complications of removal and transplantation of ovarian tissue are similar to those of standard laparoscopy. These procedures are becoming standard for fertility protection in cancer patients.

A first-in-human, randomized, controlled, subject- and reviewer-blinded multicenter study of Actamax™ Adhesion Barrier.

PURPOSE: Post-surgical adhesions remain a significant concern following abdominopelvic surgery. This study was to assess safety, manageability and explore preliminary efficacy of applying a degradable hydrogel adhesion barrier to areas of surgical trauma following gynecologic laparoscopic abdominopelvic surgery. METHODS: This first-in-human, prospective, randomized, multicenter, subject- and reviewer-blinded clinical study was conducted in 78 premenopausal women (18-46 years) wishing to maintain fertility and undergoing gynecologic laparoscopic abdominopelvic surgery with planned clinically indicated second-look laparoscopy (SLL) at 4-12 weeks. The first two patients of each surgeon received hydrogel, up to 30 mL sprayed over all sites of surgical trauma, and were assessed for safety and application only (n = 12). Subsequent subjects (n = 66) were randomized 1:1 to receive either hydrogel (Treatment, n = 35) or not (Control, n = 31); 63 completed the SLL. RESULTS: No adverse event was assessed as serious, or possibly device related. None was severe or fatal. Adverse events were reported for 17 treated subjects (17/47, 36.2%) and 13 Controls (13/31, 41.9%). For 95.7% of treated subjects, surgeons found the device "easy" or "very easy" to use; in 54.5%, some residual material was evident at SLL. For 63 randomized subjects who completed the SLL, adjusted between-group difference in the change from baseline adhesion score demonstrated a 41.4% reduction for Treatment compared with Controls (p = 0.017), with a 49.5% reduction (p = 0.008) among myomectomy subjects (n = 34). CONCLUSION: Spray application of a degradable hydrogel adhesion barrier during gynecologic laparoscopic abdominopelvic surgery was performed easily and safely, without evidence of clinically significant adverse outcomes. Data suggest the hydrogel was effective in reducing postoperative adhesion development, particularly following myomectomy.

Uterine perforation following a fractional curettage successfully treated with the modified polysaccharide 4DryField® PH: a case report.

BACKGROUND: Uterine perforation is the most common complication of curettage and may result in bleeding. Therefore, urgent control of bleeding from the uterine wall perforation is necessary to avoid an emergency hysterectomy or blood transfusion, to prevent peritoneal adhesion formation, possible chronic pelvic pain, and infertility. In the present case, an active bleeding secondary to a perforation of the uterus during curettage, for diagnosis of endometrial carcinoma, was instantaneously and successfully treated with only the application of a novel modified polysaccharide powder. This is, to the best of our knowledge, the first time that the agent 4DryField® has been used for this purpose. CASE PRESENTATION: A 71-year-old German woman with serometra and endometrial hyperplasia suffered a perforation of the anterior wall of the uterus during the hysteroscopic resection of submucosal polyps and a fractional curettage. Subsequently, an immediate laparoscopy showed an active bleeding from the wound, which was promptly stopped with only the application of the hemostatic and anti-adhesion polysaccharide powder, 4DryField®. There were no postoperative complications. Nine weeks later, a laparoscopic hysterectomy with bilateral salpingoophorectomy for endometrial carcinoma (histology: stage IA, pT1a, cN0, L0 V0 M0/G2) was performed. The former injured area looked slightly prominent, was completely healed, and showed a shiny serosa. All her pelvic organs were free of adhesions, and there was one 0.5-mm calcified granuloma in the Douglas pouch. CONCLUSIONS: The efficient hemostasis combined with the adhesion prevention effect of 4DryField®, allowed a fast control of the uterine wall bleeding, saved operation time, avoided the risks of other procedures for bleeding control and contributed to the normal healing of the uterine wall without any adhesion formation.

Long term follow-up concerning safety and efficacy of novel adhesion prophylactic agent for laparoscopic myomectomy in the prospective randomized ADBEE study.

We conducted a prospective randomized single blind - subject study in the University Clinic of Gynecology of Pius-Hospital Oldenburg. The primary objective of the ADBEE study was to assess the safety and manageability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary of myomas in women wishing to improve pregnancy outcomes. The study population included 32 women aged between 18-45 years, in good general health condition, who have not completed their family planning and who are undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes. The patients were randomized in 2 groups, ADBLOCK arm with 21 patients and surgery only arm with 11 patients. The study was single blind - subject and the investigators were blinded to treatment group assignment until completion of uterine suturing and prior to removal of the endoscope. A vigorous follow-up of subjects was organized, focusing on its two critical characteristics: completeness and duration. Completeness represented the percentage of subjects who returned to every planed follow - up appointments. The patients were evaluated in a specific period of time, which defined the duration of follow-up. Safety of the ADBLOCK was estimated after analyzing and documentation of any adverse events occurred, clinical and physical examination of patients as well as evaluation of laboratory measures. There were 25 adverse events reported in ADBLOCK treatment group and 12 events in NO-ADBLOCK group over the 24-months treatment. All adverse events in both treatment arms were not anticipated, with all events in the ADBLOCK group being resolved. At 28 days, there was no significant difference in proportion of events between the two treatments (p = 0.440). Overall, the number of events reported was low and the severity of events was generally mild with an unlikely or no relationship to treatment. There were no unanticipated device related adverse events seen in both treatment groups over the immediate post-operative period or during the 24 months follow up period. By 12 weeks all patients reported their wound as healing well or healed and at 6 months all wounds were reported as healed. There were no differences between both treatment groups regarding the use of painkillers over 24 months follow up period. This clinical first - in - human study, sustained by a rigorous follow-up of the subjects has demonstrated that ADBLOCK is a safe product, presenting no additional safety risk or burden to the patients over surgery alone. The device was relatively easy to use, with a low device failure rate that had no impact on the surgical procedures.

Use of Modified Polysaccharide 4DryField (®) PH for Adhesion Prevention and Hemostasis in Gynecological Surgery: A Two-Center Observational Study by Second-Look Laparoscopy.

Purpose. This study evaluates both scopes of 4DryField PH, certified for adhesion prevention and hemostasis, in patients undergoing surgery for various and severe gynecological disorders. Methods. This is a two-institutional study. Adhesion prevention efficacy was evaluated using video documentation of first-look laparoscopies (FLL) and second-look laparoscopies (SLL); other patient data were analyzed retrospectively. Twenty patients with various disorders were evaluated, 4 assigned to a uterus pathology, 10 to endometriosis, and 6 to an adhesion disease group. Nine patients received 4DryField primarily for hemostasis and 11 solely for adhesion prevention. Nineteen patients had SLL after 5 to 12 weeks and one after 13 months. Results. At FLL with 4DryField, immediate hemostasis could be achieved in diffuse bleeding. At SLL, effective adhesion prevention was observed in 18 of all 20 women, with only 2 revealing major adhesions. In particular, only 1 of the 6 women with adhesion disease as predominant disorder showed major adhesions at SLL. Conclusions. Modified polysaccharide 4DryField is not only effective in diffuse bleeding. In this cohort with extensive surgery for various gynecological pathologies, 4DryField showed effective adhesion prevention as confirmed at SLL, too. Its use as premixed gel is a convenient variant for treatment of large peritoneal wounds.

How to avoid risks for patients in minimal-access trials: Avoiding complications in clinical first-in-human studies by example of the ADBEE study.

A clinical trial is a prospective study designed to establish the safety and efficacy of investigational devices in humans, in accordance with the strict guidelines of the Food and Drug Administration (FDA; USA) or European Medicines Agency (EMA; Europe). Before a clinical first-in-human study is initiated, preclinical studies of the investigational product are mandatory, and the results should be sufficient to indicate that the investigational device is acceptably safe for the proposed evaluation in human subjects. The present paper describes an experience of clinical trials, highlighting ways of avoiding possible complications in clinical first-in-human studies. For a better approach to our aim, we exemplified a prospective, randomized, single-blind study, ADBEE. The primary objective was to assess the safety of the ADBLOCK system when used as an adjunct to laparoscopic primary removal of myomas in women wishing to improve pregnancy outcomes.

[Ovarian teratomas as the cause of diseases of the nervous, endocrine and haematology system].

Teratomas are the most common tumors of the ovary occurring in girls and young women. Derived from primordial germ cell and embryonic gonads have the ability to differentiate into the three germ layers. In about 95% of cases are benign, and their most common form is a dermoid cyst of the ovary. This paper aims to present the relationship described tumors of autoimmune hemolytic anemia, anti-NMDA-dependent autoimmune inflammation of the brain and thyroid disease. It reminds us that teratomas are not always insulated disease entities and may have a significant impact on the course of coexisting diseases and their treatment.

A prospective, controlled, randomized, multicenter, exploratory pilot study evaluating the safety and potential trends in efficacy of Adhexil.

OBJECTIVE: To present a multicenter, reviewer-blinded pilot study evaluating the safety and trends of efficacy of Adhexil, a novel product using fibrin sealant. DESIGN: Randomized, reviewer-blinded assessment of postoperative adhesion development in women with bilateral ovarian disease. SETTING: Gynecologic clinics. PATIENT(S): Women undergoing gynecologic surgery. INTERVENTION(S): Patients were assessed for incidence, extent, and severity of ovarian adhesions at the first-look laparoscopy (1LL), followed by standard surgical procedure. Ovaries were randomized for application of Adhexil or untreated. A second-look laparoscopy (2LL) was performed to assess postoperative adhesions. MAIN OUTCOME MEASURE(S): Safety and efficacy of Adhexil. RESULT(S): A trend toward improvement in adhesion incidence was found in the treated ovaries, with 50% (8/16) of adhesion free ovaries in the Adhexil group, versus 31% (5/16) of control ovaries. Similarly, the improvement in the mean American Fertility Society (AFS) score in the Adhexil-treated group from 1LL (6.4 ± 6.8) to 2LL (4.6 ± 6.9) was observed, whereas worsening of adhesions was observed on the control side from 1LL (5.6 ± 5.1) to 2LL (7.1 ± 6.9). No adverse events or serious adverse events considered related to the study product were reported. CONCLUSION(S): A clear trend of efficacy for Adhexil reducing the incidence, severity, and extend of adhesions in laparoscopic gynecology surgery, despite the small sample size. The use of Adhexil appears safe. Further exploration of its safety and efficacy in preventing/reducing postsurgical adhesions is warranted.

Adhesion prevention and reduction: current status and future recommendations of a multinational interdisciplinary consensus conference.

Adhesions can be found after virtually every abdominopelvic operation performed through standard laparotomy as well as by laparoscopic approaches. Adhesions can be completely asymptomatic or can cause significant morbidity and mortality including strangulation, obstruction, and necrosis of bowel loops and/or infertility and organ injury during repeat abdominal surgery. Perhaps because of the multifactorial nature of adhesion development, prevention has been very limited. Three anti-adhesion products are commercially available, none of which has been universally accepted as a panacea. Part of the obstacles with adhesion management is the lack of an objective clinically relevant classification to allow their study. Because a single band can cause a life-threatening bowel obstruction, whereas extensive dense intra-abdominal adhesions may be asymptomatic, neither the mere presence or absence of adhesions nor their extent if present is totally adequate endpoints. Adhesions are a major health care burden, and their reduction is a significant unmet need in surgical therapeutics facing all surgeons. Of all the parameters assessing adhesions currently available, the authors believe that adhesion incidence (presence or absence) is the most relevant endpoint with a direct clinical implication. The authors endorse the development of a validated, clinically relevant scale to assess intra-abdominal adhesions. Given the present limitation of objective assessment of adhesions and prediction of their clinical effect, the authors also advocate, when appropriate, the use of one of the Food and Drug Administration-approved adhesion barriers. Further research is required to develop safe and effective anti-adhesion methods as well as better assessment tools for their efficacy.