Project description:Gynaecological sarcomas account for 3-4% of all gynaecological malignancies and have a poorer prognosis compared to gynaecological carcinomas. Pivotal treatment for early-stage uterine sarcoma is represented by total hysterectomy. Whereas oophorectomy provides survival advantage in endometrial stromal sarcoma is still controversial. When the disease is confined to the uterus, systematic pelvic and para-aortic lymphadenectomy is not recommended. Removal of enlarged lymph-nodes is indicated in case of disseminated or recurrent disease, where debulking surgery is considered the standard of care. Fertility sparing surgery for uterine leiomyosarcoma is not supported by strong evidence, whilst available data on fertility sparing treatment for endometrial stromal sarcoma are more promising. For ovarian sarcomas, in the absence of specific data, it is reasonable to adapt recommendations existing for uterine sarcomas, also regarding the role of lymphadenectomy in both early and advanced stage disease. Specific recommendations on cervical sarcomas' surgery are lacking. Existing data on surgical approach vary from radical hysterectomy to fertility-preserving surgery in the form of trachelectomy or wide local excision, however no definite conclusions can be drafted on the recommended surgical approach. For vulval sarcomas, complete surgical excision with at least 2 cm of free margin is considered to be the primary treatment which is associated with good prognosis. The aim of this review is to provide highest quality evidence to guide gynaecologic oncologists throughout surgical management of gynaecological sarcomas.
Project description:The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases.
Eligible patients will be randomly assigned to one of 2 arms:
* Seprafilm group (receiving resorbable barrier membrane during the first surgery)
* No-treatment control group (without seprafilm barrier during the first surgery)
The primary objective is to establish, in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second operation.
This study is a prospective multicentric phase II, controlled, randomized and non comparative trial.
A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be assigned to the no-treatment control group. The inclusion period should be approximately 18 months. The follow up period after the second surgery will be 3 years.
Project description:BackgroundSurgery for pelvic organ prolapse, urinary incontinence, and hysterectomy are the most common gynaecological surgeries that can affect the function of the bladder and bowel as well as one's sexual life. There is evidence that adequate patient information given preoperatively regarding expected outcomes of surgery is important because well-informed patients are more satisfied with the results of surgery and recover faster. However, there is little known about the amount and quality of information given to women before surgery. This study investigates whether women received information before gynaecological surgery on the effect of surgery with respect to the functioning of the bladder (micturition, ability to stay continent) and the bowel (empty bowel) as well as the surgery's effect on sexual functioning.MethodsA prospective, cross-sectional study was conducted. Women undergoing hysterectomy, surgery for vaginal prolapse, or surgery for urinary incontinence (n = 972) and included in the Swedish National Register for Gynaecological Surgery participated in the study. A questionnaire was developed and distributed to the women along with the preoperative questionnaire from the register.ResultsAbout 50% of the women undergoing prolapse surgery were supplied with information regarding the effect of the surgery with respect to remaining continent, to emptying bowels, micturitaion, and sexual life. One out of four women undergoing hysterectomy received information about the effect of the surgery on the sexual life and bladder function. In the incontinence group, the given information about the surgery's effect on bladder function and sexual function was 80 and 30%, respectively.ConclusionSurgery in the vagina and the genital organs may affect function of the organs close to the surgical area (i.e., bladder and bowel) and may affect sexual function. According to this study, women are inadequately informed before surgery. Access to information via oral and written counselling needs to be improved.
Project description:The female reproductive tract (FRT), similar to other mucosal sites, harbours a site-specific microbiome, which has an essential role in maintaining health and homeostasis. In the majority of women of reproductive age, the microbiota of the lower FRT (vagina and cervix) microenvironment is dominated by Lactobacillus species, which benefit the host through symbiotic relationships. By contrast, the upper FRT (uterus, Fallopian tubes and ovaries) might be sterile in healthy individuals or contain a low-biomass microbiome with a diverse mixture of microorganisms. When dysbiosis occurs, altered immune and metabolic signalling can affect hallmarks of cancer, including chronic inflammation, epithelial barrier breach, changes in cellular proliferation and apoptosis, genome instability, angiogenesis and metabolic dysregulation. These pathophysiological changes might lead to gynaecological cancer. Emerging evidence shows that genital dysbiosis and/or specific bacteria might have an active role in the development and/or progression and metastasis of gynaecological malignancies, such as cervical, endometrial and ovarian cancers, through direct and indirect mechanisms, including modulation of oestrogen metabolism. Cancer therapies might also alter microbiota at sites throughout the body. Reciprocally, microbiota composition can influence the efficacy and toxic effects of cancer therapies, as well as quality of life following cancer treatment. Modulation of the microbiome via probiotics or microbiota transplant might prove useful in improving responsiveness to cancer treatment and quality of life. Elucidating these complex host-microbiome interactions, including the crosstalk between distal and local sites, will translate into interventions for prevention, therapeutic efficacy and toxic effects to enhance health outcomes for women with gynaecological cancers.
Project description:Interventions: A piece of dried interceed which is 3-5mm larger than the surgery site will be placed to prevent adhesion just before abdominal closure of the laparoscopic surgery.
Normal laparoscopic surgery (without interceed)
Primary outcome(s): Frequency of serious adverse event within 30 days from surgery.
Study Design: Parallel Randomized
Project description:ObjectiveTo assess the prevalence, outcomes and cost associated with acute kidney injury (AKI) defined by consensus risk, injury, failure, loss, and end-stage kidney (RIFLE) criteria after gynaecologic surgery.DesignRetrospective single-centre cohort study.SettingAcademic medical centre.SampleTwo thousand three hundred and forty-one adult women undergoing major inpatient gynaecologic surgery between January 2000 and November 2010.MethodsAKI was defined by RIFLE criteria as an increase in serum creatinine greater than or equal to 50% from the reference creatinine. We used multivariable regression analyses to determine the association between perioperative factors, AKI, mortality and cost.Main outcome measuresAKI, combined major adverse events (hospital mortality, sepsis or mechanical ventilation), 90-day mortality and hospital cost.ResultsOverall prevalence of AKI was 13%. The prevalence of AKI was associated with the primary diagnosis. Of women with benign tumour surgeries, 5% (43/801) experienced AKI compared with 18% (211/1159) of women with malignant disease (P < 0.001). Only 1.3% of the whole cohort had evidence of urologic mechanical injury. In a multivariable logistic regression analysis, AKI patients had nine times the odds of a major adverse event compared to patients without AKI (adjusted odds ratio 8.95, 95% confidence interval 5.27-15.22). We have identified several readily available perioperative factors that can be used to identify patients at high risk for AKI after in-hospital gynaecologic surgery.ConclusionsAKI is a common complication after major inpatient gynaecologic surgery associated with an increase in resource utilisation and hospital cost, morbidity and mortality.
Project description:BackgroundThere are limited data on surgical outcomes in gynaecological oncology. We report on predictors of complications in a multicentre prospective study.MethodsData on surgical procedures and resulting complications were contemporaneously recorded on consented patients in 10 participating UK gynaecological cancer centres. Patients were sent follow-up letters to capture any further complications. Post-operative (Post-op) complications were graded (I-V) in increasing severity using the Clavien-Dindo system. Grade I complications were excluded from the analysis. Univariable and multivariable regression was used to identify predictors of complications using all surgery for intra-operative (Intra-op) and only those with both hospital and patient-reported data for Post-op complications.ResultsProspective data were available on 2948 major operations undertaken between April 2010 and February 2012. Median age was 62 years, with 35% obese and 20.4% ASA grade ?3. Consultant gynaecological oncologists performed 74.3% of operations. Intra-op complications were reported in 139 of 2948 and Grade II-V Post-op complications in 379 of 1462 surgeries. The predictors of risk were different for Intra-op and Post-op complications. For Intra-op complications, previous abdominal surgery, metabolic/endocrine disorders (excluding diabetes), surgical complexity and final diagnosis were significant in univariable and multivariable regression (P<0.05), with diabetes only in multivariable regression (P=0.006). For Post-op complications, age, comorbidity status, diabetes, surgical approach, duration of surgery, and final diagnosis were significant in both univariable and multivariable regression (P<0.05).ConclusionsThis multicentre prospective audit benchmarks the considerable morbidity associated with gynaecological oncology surgery. There are significant patient and surgical factors that influence this risk.
Project description:A study was undertaken to evaluate the effectiveness of acupuncture as an anti-emetic in patients undergoing minor gynaecological surgery. 100 patients were studied divided into study group (Group I) and control group (Group II) of 50 patients each. In group I patients, acupuncture needle was inserted at acupuncture point P6, 10 minutes before induction of anesthesia. In group II, no acupuncture was used. Anaesthetic technique was similar in both the groups. Five patients (10%) in group I and twenty (40%) in group II had one or more emetic episodes. These results show that acupuncture can be one of the modalities for the prevention of nausea and vomiting in postoperative period and its use as an anti-emetic should be explored further.
Project description:Fast-track surgery (FTS), also known as enhanced recovery after surgery, is a multidisciplinary approach to accelerate recovery, reduce complications, minimise hospital stay without increasing readmission rates, and reduce health care costs, all without compromising patient safety. The advantages of FTS in abdominal surgery most likely extend to gynaecological surgery, but this is an assumption, as FTS in elective gynaecological surgery has not been well studied. No consensus guidelines have been developed for gynaecological oncological surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. To our knowledge, there are no published randomised controlled trials; however, some studies have shown that FTS in gynaecological oncological surgery leads to early hospital discharge with high levels of patient satisfaction. The aim of this study is whether FTS reduces the length of stay in hospital compared to traditional management. The secondary aim is whether FTS is associated with any increase in post-surgical complications compared to traditional management (for both open and laparoscopic surgery).This trial will prospectively compare FTS and traditional management protocols. The primary endpoint is the length of post-operative hospitalisation (days, mean?±?standard deviation), defined as the number of days between the date of discharge and the date of surgery. The secondary endpoints are complications in both groups (FTS versus traditional protocol) occurring during the first 3 months post-operatively including infection (wound infection, lung infection, intraperitoneal infection), post-operative nausea and vomiting, ileus, post-operative haemorrhage, post-operative thrombosis, and the Acute Physiology and Chronic Health Enquiry II score.The advantages of FTS most likely extend to gynaecology, although, to our knowledge, there are no randomised controlled trials. The aim of this study is to compare the post-operative length of hospitalisation after major gynaecological or gynaecological oncological surgery and to analyse patients' post-operative complications. This trial may reveal whether FTS leads to early hospital discharge with few complications after gynaecological surgery.NCT02687412 . Approval Number: SCCHEC20160001. Date of registration: registered on 23 February 2016.