Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

The LLETZ procedure will be performed under local anaesthesia

The LLETZ procedure will be performed under general anaesthesia

Conization will be performed under local anaesthesia

LLETZ under local anaesthesia

Conization will be performed under general anaesthesia

LLETZ under general anaesthesia

Ziad Hilal, M.D.

The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.

LLETZ Under General Versus Local Anesthesia

Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.

Patients will score their satisfaction by using a 11-step visual analogue scale (VAS) ranging from '0' ("not satisfied at all") to '10' ("very satisfied") 2 hours after Treatment

patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) ranging from '0' ("no pain" ) to '10' ("maximum pain") within 2 hours after surgery

the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room

the time from the beginning of the Operation (start of the electrosurgical method) until the end of the operation (the end of hemostatic interventions) will be measured in minutes

Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively

the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds

Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment

surgeons will count the number of the surgical specimen (1 vs. \>1)

The circumference, length and thickness of The surgical specimens will be measured

intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively

Resection margin is judge as "R0" if abnormal cells are not found in the margin of the biopsy or "R1" if abnormal cells remain in the margin of the biopsy. The histopathological examination will be done by an Independent pathologist

Zydolab - Institute of Cytology and Immune Cytochemistry

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Sentinel Node Procedure under General Anaesthesia

Sentinel Node Procedure under Local Anaesthesia

Martijn Leenders, MD

Hermien Schreurs, MD, PhD

Anne Roukema, MD, PhD, Prof

Shirley Go, MD

Henk-Jan Slooten van, MD, PhD

Metha Klaver, PhD

Tjeerd Ploeg, van der, PhD

Rationale: In breast cancer (BC) patients, lymph node status is a key prognostic indicator. At present, axillary ultrasound (US) with subsequent fine needle aspiration cytology (FNAC) of suspicious lymph nodes (US+FNAC) is widely used as a pre-operative staging method. When US+FNAC is negative, a sentinel node procedure (SNP) is performed during breast surgery. Nowadays, an axillary lymph node dissection (ALND) is generally performed if one of the abovementioned diagnostic entities reveals lymph node metastases. However, the extensive role of ALND in BC patients with lymph node metastases may change or diminish in upcoming years due to emerging evidence that completion ALND (cALND) does not affect disease-free survival and overall survival in early BC patients with (sentinel) node-positive disease. Whether ALND is needed in these patients, should be based on (axillary) tumour load. Because of the fact that tumour load can only be reliably evaluated by SNP and not by US+FNAC, the role of SNP might become even more important in upcoming years.

Ideally, the status of this sentinel lymph node is known prior to breast surgery, so a patient tailored treatment plan can be made and discussed with the patient before breast surgery. In this context, it would be very logical to perform a SNP under local anaesthesia (LA), prior to breast surgery. This might not only lead to significantly less two-step surgical procedures under general anaesthesia (GA), but might also lead to a reduction of depressive symptoms and anxiety and improved quality of life (QoL) of BC patients, because BC patients are in particular risk for psychological distress in the first three months after diagnosis of BC. Knowing lymph node status and the complete treatment plan as soon as possible (by performing a SNP under LA), might reduce this psychological distress. To investigate which BC patients would benefit most from SNP under LA, the investigators recently analysed 1132 BC patients retrospectively. Both prevalence of axillary lymph node metastases and prevalence of false negative results of US+FNAC were directly associated with age \<60 years and with primary breast tumour size \>20 mm. Hence, these BC patients might benefit most from SNP under LA. In the present study, the value of SNP under LA in these BC patients (i.e. \<60 years with a breast carcinoma \>20 mm) will be analysed.

Objectives: Reduction of the mean number of operations under general anaesthesia per patient. Improvement of QoL. Reduction of depressive symptoms and experienced anxiety.

Study design: Prospective single centre randomised controlled clinical trial. Study population: Women aged 18 to 60 years who are diagnosed with BC AND with a tumour size of \>20 mm ultrasonographically AND with a negative or inconclusive pre-operative US+FNAC.

Intervention: Sentinel Node Procedure under Local Anaesthesia (SNP under LA) Control: Traditional Sentinel Node Procedure under General Anaesthesia (SNP under GA) Main study parameters: Primary outcome parameters are the number of operations under GA per patient and the number of operations under LA per patient. Secondary outcome parameters are QoL, experienced depressive symptoms and anxiety.

Timeline and statistics: The inclusion period will be conducted from the 1st of July 2014 to the 1st of August 2015, and 80 patients will be enrolled in this study (alpha 0.05; power 0.8). Inclusion of 80 patients will be sufficient to reduce the number of two-stage surgical procedures under general anaesthesia with 30%. Data will be analysed using descriptive statistics, Chi-squared test, Fisher's exact test, Mann-Whitney U test, Kruskall-Wallis test, students t-test, ANOVA, paired t-test, Wilcoxon signed-rank test, Friedman test, Pearson's and Spearman's rank correlation coefficients and finally logistic and linear regression analysis.

Ambulatory SNP Under Local Anaesthesia in a Subgroup of Breast Cancer Patients - Trial

A Prospective Single-centre Randomised Controlled Clinical Trial Comparing Sentinel Node Procedure Under Local Anaesthesia to Traditional Sentinel Node Procedure Under General Anaesthesia in Patients <60 Years With a Breast Carcinoma >20 mm.

Pain during SNP under local anaesthesia is measured with a Numeric Pain Rating Scale

Quality of Life is measured with the WHOQOL-bref questionnaire

Depressive symptoms are measured with the Centre for Epidemiological Studies-Depression scale (CES-D)

Anxiety is measured with the State-and-Trait-Anxiety-Inventory (STAI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LLETZ Under General Versus Local Anesthesia	NCT03494686	Uterine Cervica...	LLETZ under loc... LLETZ under gen...	18 Years -	Zydolab - Institute of Cytology and Immune Cytochemistry
Ambulatory SNP Under Local Anaesthesia in a Subgroup of Breast Cancer Patients - Trial	NCT02187718	Breast Neoplasm...	Sentinel Node P... Sentinel Node P...	18 Years - 60 Years	Medical Center Alkmaar
LLETZ Under General Versus Local Anesthesia	NCT03494686	Uterine Cervica...	LLETZ under loc... LLETZ under gen...	18 Years -	Zydolab - Institute of Cytology and Immune Cytochemistry

Spots Global Cancer Trial Database for local anaesthesia