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- Salvo, G, et al.
(författare)
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International radical trachelectomy assessment: IRTA study
- 2019
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Ingår i: International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. - : BMJ. - 1525-1438. ; 29:3, s. 635-638
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Tidskriftsartikel (refereegranskat)abstract
- Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy.Primary ObjectiveTo compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy.Study HypothesisWe hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach.Study DesignThis is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional review board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data.Inclusion CriteriaPatients with squamous, adenocarcinoma, or adenosquamous cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size ≤2 cm, by physical examination, ultrasound, MRI, CT, or positron emission tomography (at least one should confirm a tumor size ≤2 cm). Centers must contribute at least 15 cases of radical trachelectomy (open, minimally invasive, or both).Exclusion CriteriaPrior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra-operative conversion to radical hysterectomy), or vaginal approach.Primary EndpointThe primary endpoint is disease-free survival measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare disease-free survival among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy.Sample SizeAn estimated 535 patients will be included; 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8% to 7.6%. Assuming that the 4.5-year disease-free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 HR using α level 0.10. This corresponds to an 89.0% disease-free survival rate at 4.5 years in the minimally invasive group.
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| 117. |
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| 118. |
- Wang, Y, et al.
(författare)
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Metamorphopsia after successful retinal detachment surgery: an optical coherence tomography study
- 2005
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Ingår i: Acta Ophthalmologica Scandinavica. - : Wiley. - 1395-3907. ; 83:2, s. 168-171
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To investigate the findings in optical coherence tomography (OCT) in eyes with metamorphopsia after scleral buckling surgery for macula-off retinal detachment. Methods: A total of 46 patients (46 eyes) with macula-off retinal detachment were prospectively studied 2 months after successful scleral buckling surgery. Patients were examined with the Amsler grid, fundus biomicroscopy and OCT. Results: At the 2 month follow-up, 31/46 (67%) patients had metamorphopsia; 24/31 (77%) of these patients had an abnormal macular structure on OCT and 7/31 (23%) showed a normal macula. However, of the 15 patients in the nonmetamorphopsia group, 4/15 (27%) had an abnormal macula and 11/15 (73%) had a normal macula (p = 0.0015). The most common finding on OCT was neurosensory retinal detachment. Conclusions: Metamorphopsia after scleral buckling surgery in macula-off detachment is more common in patients in whom abnormal macular structure is seen on the OCT scan compared to those showing a normal macular structure. Neurosensory retinal detachment is the most common pathology in these patients.
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