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1.
Geburtshilfe Frauenheilkd ; 83(2): 165-183, 2023 Feb.
Article in English | MEDLINE | ID: mdl-37151735

ABSTRACT

Purpose This guideline provides recommendations for the diagnosis, treatment and follow-up care of 3rd and 4th degree perineal tears which occur during vaginal birth. The aim is to improve the management of 3rd and 4th degree perineal tears and reduce the immediate and long-term damage. The guideline is intended for midwives, obstetricians and physicians involved in caring for high-grade perineal tears. Methods A selective search of the literature was carried out. Consensus about the recommendations and statements was achieved as part of a structured process during a consensus conference with neutral moderation. Recommendations After every vaginal birth, a careful inspection and/or palpation by the obstetrician and/or the midwife must be carried out to exclude a 3rd or 4th degree perineal tear. Vaginal and anorectal palpation is essential to assess the extent of birth trauma. The surgical team must also include a specialist physician with the appropriate expertise (preferably an obstetrician or a gynecologist or a specialist for coloproctology) who must be on call. In exceptional cases, treatment may also be delayed for up to 12 hours postpartum to ensure that a specialist is available to treat the individual layers affected by trauma. As neither the end-to-end technique nor the overlapping technique have been found to offer better results for the management of tears of the external anal sphincter, the surgeon must use the method with which he/she is most familiar. Creation of a bowel stoma during primary management of a perineal tear is not indicated. Daily cleaning of the area under running water is recommended, particularly after bowel movements. Cleaning may be carried out either by rinsing or alternate cold and warm water douches. Therapy should also include the postoperative use of laxatives over a period of at least 2 weeks. The patient must be informed about the impact of the injury on subsequent births as well as the possibility of anal incontinence.

2.
Maturitas ; 167: 1-7, 2023 01.
Article in English | MEDLINE | ID: mdl-36279690

ABSTRACT

BACKGROUND: Urogenital atrophy affects >50 % of women after breast cancer (BC) and there is reluctance to use local estrogen for this group. Hormone-free therapies like intravaginal laser therapy and hyaluronic acid suppositories have been shown to produce symptom relief in women with BC and urogenital atrophy, but have not been tested against each other. The aim of this study was to compare these nonhormonal modalities in women with urogenital atrophy after BC in a randomized fashion. STUDY DESIGN: We randomly assigned 43 women (aged 49-58 years, mean age 54 years) with urogenital atrophy and a history of BC to receive intravaginal laser therapy (2 courses within 1 month) or hyaluronic acid suppositories (3 times/week continuously for three months). The primary endpoint was score on the Vaginal Health Index after 3 months. Secondary endpoints were subjective bother on a numeric rating scale for all urogenital atrophy domains, quality of life, sexual health and pelvic organ prolapse symptoms using validated questionnaires. RESULTS: Of the 43 women who participated, 22 were randomized to intravaginal laser therapy, and 21 to vaginal suppositories. At 3 months score on the Vaginal Health Index had improved significantly in both groups (p = 0.001), without a significant difference between treatment groups (p = 0.232). Significant improvement was also seen in both groups for subjective bother of urogenital atrophy, quality of life and sexual health, without significant differences between laser or hyaluronic acid therapy. CONCLUSIONS: Both intravaginal laser therapy and hyaluronic acid suppositories are effective treatment options for women after BC suffering from urogenital atrophy. No difference was found between treatment regimens. CLINICALTRIALS: gov identifier: NCT03816735, https://clinicaltrials.gov/ct2/show/NCT03816735.


Subject(s)
Breast Neoplasms , Laser Therapy , Vaginal Diseases , Female , Humans , Suppositories , Breast Neoplasms/complications , Breast Neoplasms/radiotherapy , Breast Neoplasms/drug therapy , Hyaluronic Acid/therapeutic use , Quality of Life , Vagina/pathology , Atrophy/pathology , Lasers , Vaginal Diseases/drug therapy , Vaginal Diseases/etiology , Administration, Intravaginal
3.
J Clin Oncol ; 40(5): 449-458, 2022 02 10.
Article in English | MEDLINE | ID: mdl-34995105

ABSTRACT

PURPOSE: The PALLAS study investigated whether the addition of palbociclib, an oral CDK4/6 inhibitor, to adjuvant endocrine therapy (ET) improves invasive disease-free survival (iDFS) in early hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In this analysis, we evaluated palbociclib exposure and discontinuation in PALLAS. METHODS: Patients with stage II-III HR+, HER2- disease were randomly assigned to 2 years of palbociclib with adjuvant ET versus ET alone. The primary objective was to compare iDFS between arms. Continuous monitoring of toxicity, dose modifications, and early discontinuation was performed. Association of baseline covariates with time to palbociclib reduction and discontinuation was analyzed with multivariable competing risk models. Landmark and inverse probability weighted per-protocol analyses were performed to assess the impact of drug persistence and exposure on iDFS. RESULTS: Of the 5,743 patient analysis population (2,840 initiating palbociclib), 1,199 (42.2%) stopped palbociclib before 2 years, the majority (772, 27.2%) for adverse effects, most commonly neutropenia and fatigue. Discontinuation of ET did not differ between arms. Discontinuations for non-protocol-defined reasons were greater in the first 3 months of palbociclib, and in the first calendar year of accrual, and declined over time. No significant relationship was seen between longer palbociclib duration or ≥ 70% exposure intensity and improved iDFS. In the weighted per-protocol analysis, no improvement in iDFS was observed in patients receiving palbociclib versus not (hazard ratio 0.89; 95% CI, 0.72 to 1.11). CONCLUSION: Despite observed rates of discontinuation in PALLAS, analyses suggest that the lack of significant iDFS difference between arms was not directly related to inadequate palbociclib exposure. However, the discontinuation rate illustrates the challenge of introducing novel adjuvant treatments, and the need for interventions to improve persistence with oral cancer therapies.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Piperazines/therapeutic use , Protein Kinase Inhibitors/therapeutic use , Pyridines/therapeutic use , Receptor, ErbB-2/analysis , Receptors, Estrogen/analysis , Receptors, Progesterone/analysis , Antineoplastic Agents, Hormonal/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/enzymology , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Disease-Free Survival , Female , Humans , Neoplasm Staging , Piperazines/adverse effects , Protein Kinase Inhibitors/adverse effects , Pyridines/adverse effects , Risk Factors , Time Factors
4.
Reprod Sci ; 28(12): 3515-3518, 2021 12.
Article in English | MEDLINE | ID: mdl-34611849

ABSTRACT

There are few data on complications with gender affirming surgery. The aim of this study was to assess peri- and postoperative complications of laparoscopic hysterectomy and mastectomy performed in a single sitting in transgender men. Assessment of intra- and postoperative complications in a series of 65 transgender men (mean age 27, range 18-47) undergoing concomitant mastectomy and laparoscopic hysterectomy with salpingo-oophorectomy. Mean operating time was 292 ± 47 min. Thirty-four (52%) patients experienced complications: 28 (41%) DINDO grade I, 0 DINDO grade 2, 6 (11%) DINDO grade III. The six grade 3 complications consisted of 5 hematomas requiring evacuation after mastectomy and 2 vaginal tears requiring transvaginal repair. Three patients were readmitted within 30 days, all for postoperative bleeding/hematoma. In transgender men, performing laparoscopic hysterectomy and mastectomy at a single sitting has a modest rate of perioperative complications, and may improve resource utilization.


Subject(s)
Hysterectomy/methods , Laparoscopy/methods , Mastectomy/methods , Postoperative Complications/diagnosis , Salpingo-oophorectomy/methods , Transgender Persons , Adult , Cohort Studies , Combined Modality Therapy/adverse effects , Combined Modality Therapy/methods , Female , Follow-Up Studies , Humans , Hysterectomy/adverse effects , Laparoscopy/adverse effects , Male , Mastectomy/adverse effects , Middle Aged , Postoperative Complications/epidemiology , Retrospective Studies , Salpingo-oophorectomy/adverse effects
5.
Geburtshilfe Frauenheilkd ; 80(8): 813-819, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32817988

ABSTRACT

After the first case of COVID-19 pneumonia was reported in Wuhan, Hubei Province, China, in December 2019, the infection quickly spread to the rest of China and then to the wider world. The available information on pregnant women infected with COVID-19 is now significantly greater. There are now several case series and systematic reviews of cohorts, some of which include more than 100 cases. This review evaluates the scientific literature available until May 1, 2020 and discusses common questions about COVID-19 in the context of pregnancy and the postpartum period.

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