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Surgery clinical trials

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NCT ID: NCT04470076 Not yet recruiting - Surgery Clinical Trials

Neoadjuvant Afatinib Combination With Chemotherapy for Stage Ⅱa-Ⅲb NSCLC With EGFR Activating Mutation

Neoafa
Start date: July 10, 2020
Phase: Phase 2
Study type: Interventional

The recommended adjuvant therapy for stage Ⅱa-Ⅲb Non-small cell lung cancer (NSCLC) were perioperative chemotherapy. The adjuvant or neoadjuvant chemotherapy for early stage lung cancer improved about 5% 5-year survival. As for advanced NSCLC with epidermal growth factor receptor (EGFR) activating mutation, epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) combination with chemotherapy had improved progression-free survival (PFS) compared with EGFR-TKI alone. We propose this trial of Neoadjuvant Afatinib Combination With Chemotherapy for Stage Ⅱa-Ⅲb NSCLC With EGFR Activating Mutation, which would maximize benefit early in a patient's treatment course. At the same time, dynamic 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography (18F-FDG PET) was used to evaluate the standardized uptake value (SUV) and uptake rate constant (Ki) changes of lesions before and after treatment, so as to accurately and quantitatively monitor the tumor response of different therapy.

NCT ID: NCT04440332 Not yet recruiting - Surgery Clinical Trials

Surveillance of Peripheral Blood of Lymphocyte and Immunocyte in Neoadjuvant Therapy Patients With Esophageal Squamous Cell Carcinoma (pLINE)

Start date: July 1, 2020
Phase:
Study type: Observational

Neoadjuvant chemoradiotherapy treatment represents the standard approach for resectable locally advanced esophageal squamous cell carcinoma. The incidence of pulmonary infection and other perioperative complications were higher in patients who received esophagectomy and neoadjuvant chemoradiotherapy than those without neoadjuvant treatment and surgery patients. However, reliable clinical data can quantify the damage degree of immunologic function caused by chemotherapy and radiotherapy is still unknown. This project regards the level of lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic change of the immunologic function of patients with locally advanced esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy treatment. Meanwhile, the investigators will also investigate the relationship between the level of lymphocyte and immunocyte in peripheral blood and the response rate of neoadjuvant therapy.

NCT ID: NCT04426136 Not yet recruiting - Breast Cancer Clinical Trials

A Prospective Cohort Study Comparing Disparity in Surgical Procedure (Wide Local Excision Only vs Any Other Surgery Procedures) Among the Elderly Breast Cancer Patients

Start date: June 2020
Phase:
Study type: Observational [Patient Registry]

The incidence and mortality rates of breast cancer are still increasing in both developing and developed countries. The number of women ≥70 years who are affected by breast cancer (BC) worldwide is also on the increase. Based on the largest population and increasing aging, BC is also rapidly increasing among the elderly in China. According to the epidemiological profile data regarding BC in China, the second onset age peak of BC morbidity occurred after 70 years old and in 2020, the proportion of patients older than 65 is expected to exceed one-fifth and reach 27.0% by 2030. However, some controversies remain to be resolved due to the lack of high quality evidence. The tumor biological behavior, treatment choice and treatment tolerance among the elderly prominently differ from their young counterparts. Besides, they are rarely enrolled in large-scale randomized clinical trials or prospective cohort studies and the results are obtained mainly from retrospective studies. Also, frequent deviations from the standard guidelines lead to insufficient or excessive treatments, though the so-called standard guidelines are based on the clinicopathological characteristics and research findings among the younger BC patients. Studies focusing on the global population confirmed that the biological behavior of tumors among elderly patients was more favorable compared with younger patients but did not transform into survival benefits eventually. Numerous prospective, randomized trials have demonstrated that breast conserving surgery (BCS), consisting of segmental mastectomy and radiation treatment with or without axillary lymph node dissection (ALND), is equivalent to mastectomy in terms of overall survival (OS) and disease free survival (DFS) for patients with early stage breast carcinoma. Presentation of the ACOZOG-Z011 study results in 2011 resulted in a downward trend in the use of a completion axillary lymph node dissection in early breast cancer patients with 1-2 positive sentinel lymph nodes (SLN), treated with wide local excision (WLE) and whole breast irradiation. However, there is little evidence regarding the optimal axillary treatment in elderly breast cancer patients, since these patients are often excluded from clinical trials. We had done a retrospective study of breast cancer in the elderly, which demonstrated that those who with complex comorbidities receiving wide local excision merely were about 1.5 times more than those who without (71.2% vs 46.0%, p<0.001). However, it is paradoxical that, on the one hand, the risk of dying from breast cancer may increase if patients do not receive the standard treatment; on the other hand, they could not live long enough to benefit or even suffer more from the standard treatment. The key is to figure out who they are. Given the high proportion of patients treated only with WLE, we believe that it is important to compare the effects of different surgical procedures on prognosis among the elderly BC patient in a prospective cohort study, to be more specific, comparing the WLE versus any other surgical procedures.

NCT ID: NCT04387487 Not yet recruiting - Anxiety Clinical Trials

Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Our primary aim is to compare the effect of pre-operative multimedia video information on perioperative anxiety and hemodynamic parameters.

NCT ID: NCT04339231 Not yet recruiting - Surgery Clinical Trials

Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia

Start date: April 25, 2020
Phase: N/A
Study type: Interventional

Transsphenoidal surgery is considered safe and effective and is currently the procedure of choice for the removal of intrasellar lesions. Direct transnasal access to the sphenoid sinus, without the need for detachment of the nasal septum, provides less postoperative morbidity compared to traditional methods. Sphenopalatine ganglion block is known for its efficacy in otorhinolaryngological surgeries in which the sinuses are approached by transnasal endoscopy, as an important part of postoperative analgesia. However, in a neurosurgical environment, specifically in the treatment of tumors of the sella turcica, the use of the blockade of the referred ganglion to produce postoperative analgesia has been used in a scarce way in the literature. The primary objective of the study is to verify whether blocking the sphenopalatine nerve ganglion in the nasopharynx posterior wall provides better postoperative pain control in surgeries with nasal access for transsphenoidal approach, compared to the placebo group. As secondary objectives, the investigators will observe the consumption of opioids in the intraoperative period, in addition to the incidence of nausea, vomiting and postoperative headache also within 24 hours. Forty patients with physical status P1, P2 or P3 will be prospectively analyzed by the American Society of Anesthesiology (ASA) to undergo microsurgery for tumors with a sellar and / or suprasellar location, with transsphenoidal access, in patients with an age range between 18 and 64 years old, including men and women.

NCT ID: NCT04172545 Not yet recruiting - Surgery Clinical Trials

Observational Study on Effect of Anesthetic Conditions on Stapling Thickness

Start date: August 2020
Phase:
Study type: Observational

Measure anesthetic condition used during laparoscopic sleeve gastrectomy stapling. Measure quality of stapling in resected stomach by measuring staple thickness. Find if any relation exists.

NCT ID: NCT04170400 Not yet recruiting - Surgery Clinical Trials

Observational Study Comparing Gastric Calibration Tubes

Start date: December 2019
Phase:
Study type: Observational

Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery. Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

NCT ID: NCT04170322 Not yet recruiting - Surgery Clinical Trials

Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

Start date: August 2020
Phase: N/A
Study type: Interventional

Time from 40 Fr gastric calibration tube introduction on surgical request till first stapling is measured as introduction time. Problems to advance are noted A note is made If change to other type of gastric tube is needed

NCT ID: NCT04168346 Not yet recruiting - Gastric Cancer Clinical Trials

Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

IRONSTOMACH
Start date: November 2019
Phase: Phase 4
Study type: Interventional

The main objective of this investigator initiated study is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.

NCT ID: NCT04130022 Not yet recruiting - Surgery Clinical Trials

Premedication Gastric Ultrasound

Start date: June 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess gastric volume in fasted children using ultrasound before and after drinking premedication. The hypothesis is that the qualitative and quantitative assessment by gastric ultrasound in the stomach before and after drinking premedication will be the same as premedication has a small volume.