Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Rare Diseases

Ovarian Neoplasms

Hyperthermia

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Coagulants

All Drugs and Chemicals

Hemostatics

After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)

After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

FloSeal application

Electrocautery

Joo-Hyun Nam, M.D., Ph.D.

To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy

Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY

Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.

Baxter Healthcare Corporation

Asan Medical Center

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Harmonic ACE23P Scalpel

Laura Pine, RN, BSN

Michelle Collier, RN, BSN

Kirk Fleischer, MD

Michael McGrath, MD

Jeffrey Rich, MD

Joseph Newton, MD

In an effort to elucidate whether the Harmonic Scalpel will improve sealing lymphatics and decrease lymphatic drainage thereby decreasing the length of time that chest tubes are required and minimizing length of stay; the Harmonic Scalpel will be compared to a control group which uses electrocautery. This study will assess these two different methods to determine if there is a notable decrease in the amount of drainage with one versus the other.

Lymph node dissection is an integral part of the surgical management of lung cancer. Knowledge of lymph node status plays a key role in therapeutic decision making and prognosis. Associated with this dissection comes the propensity for lymphatic leakage, increased chest tube drainage, prolonged retention of chest tubes in the postoperative period and increased patient length of stay. Our center performs complete mediastinal node dissection of all relevant regional lymph nodes which generally include paratracheal, pretracheal, subcarinal, hilar and paraesophageal nodes. The current standard of practice for the dissection of the lymph nodes includes the use of the Harmonic Scalpel or electrocautery. Known risk of electrocautery include localized nerve damage, cardiac arrhythmias and damage to the tissue sample/specimen that is used for pathology. The Harmonic Scalpel technology has recently become available for use. Current experience with the Harmonic Scalpel suggests that there is less localized nerve damage, less incidence of arrhythmias, less damage to the tissue sample and less lymph leakage. There is no published data to support this hypothesis, thus the purpose of this study.

Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.

Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy. A Single Center Prospective Randomized Controlled Study.

Ethicon Endo-Surgery

Sentara Cardiovascular Research Institute

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Dissection with harmonic scalpel in modified radical mastectomy

Harmonic

Dissection in modified radical mastectomy

electrocautery

Shaista M Khan, FRCS

To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL), operating time, drain Volume and drain Days, seroma formation, surgical site infection and postoperative pain in adult females undergoing MRM at a tertiary care hospital. We hypothesized that harmonic yields better outcome than electrocautery dissection.

In this randomized controlled trial, adult females who underwent MRM between April 2010 and July 2011 were randomized to receive either intervention A (harmonic scalpel) or B (electrocautery). The procedure was standardized except elevation of flaps and axillary dissection, that was performed as per randomization. Patients were followed up in clinic for four weeks. The outcomes were estimated blood loss (EBL), operating time, drain Volume and drain Days, complications (seroma, surgical site infection, hematoma and flap necrosis) and postoperative pain.

Use of Harmonic in Breast Surgery

Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial

Durations of drains in place after MRM: Patients were followed in clinic every 3rd day and drains were removed once the volume was \<30ml a day.

Time taken in minutes from incision to skin closure

Daily charting of drain volume at a specified time with regular recording in routine clinic follow ups till the drains were is place.

Patients were followed up till 3o days. If any of the following were found, the patient was labelled to have complication:

Seroma- fluctuant swelling under the flaps; SSI- as per CDC criteria; Hematoma- swelling under flaps with characteristic bruising; Flap necrosis- partial or complete necrosis of flaps.

Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours

Aga Khan University

Co Principal Investigator

Lung Injury

Thoracic Injuries

minimally invasive surgical procedures during which a smoke evacuation device is used

minimally invasive surgical procedures during which no smoke evacuation device is used

open surgical procedures during which a smoke evacuation device is used

open surgical procedures during which no smoke evacuation device is used

The smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated

Smoke evacuation system

Gregor J Kocher, PD, MD

The investigators will define two separate groups of surgical procedures: 1.) an 'open group' in which mainly open anatomic lung resections will be included, and 2.) a 'minimally invasive' group in which mainly thoracoscopic anatomic lung resections will be included.

Both groups will then be randomized to either the performance of the surgical procedure under 'standard conditions' or to the performance of the procedure with the additional use of a smoke evacuation system.

During every procedure the hazardous smoke that is generated by the electrocautery in the surgical field will be collected through a tube at the height of the surgeons face. The smoke is then directly transferred to a mass spectrometer that is situated in the operating room (OR) and performs a real-time analysis of the chemical substances in the air. The degree of air pollution will be measured as well as the smoke evacuation systems' ability to reduce these hazardous chemical substances in the air can be evaluated.

Smoke samples will be continuously analyzed with a latest generation time of flight mass spectrometer in real time. Concerning the smoke evacuation device, the investigators will use the model IES 2 (Intelligent Evacuation System) from Erbe Swiss medical for this study.

Since this is only an observational study in which the investigators are only recording the type of surgery (i.e. open oder minimally invasive) and not recording sensitive patient data, the local ethics committee waived the need for an ethics committee approval of the study. In the end the smoke evacuation system does not have an effect on the patient or the procedure itself, but may rather influence the concentration of hazardous surgical fumes in the operating theatre.

Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System in the Surgical Unit

Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System (SES) in the Surgical Unit

Analysis of surgical fume with real-time time of flight mass spectrometry

Tofwerk AG, Thun Switzerland (equipment, data analysis)

Lungenliga Bern (main funding)

Erbe Swiss AG (equipment)

Insel Gruppe AG, University Hospital Bern

Infections

Immune System Diseases

Digestive System Diseases

Carcinoma

Carcinoma, Squamous Cell

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Virus Diseases

HIV Seropositivity

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Vaccines

Ablative therapy involving electrocautery (EC) will occur for participants with AIN-2 and AIN-3. The Hyfrecator ® 2000 Electrosurgical System will be used for EC therapy.

The control arm includes active surveillance with observation alone; no treatment in AIN-2 and -3.

Lesion is ablated by the The Hyfrecator ® 2000 Electrosurgical System. During electrocautery (EC) with The Hyfrecator, a gentle brushing technique occurs and the tissue is removed with forceps.

The Hyfrecator ® 2000 Electrosurgical System

No treatment to AIN-2 or AIN-3, only active surveillance.

Observation Alone

Irving Salit, MD

Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several cancers in men, notably squamous cell carcinoma (SCC) of the anal canal. Rates of anal infection with these HR-HPV strains and the resultant high-grade anal dysplasia and anal cancer are much higher in men who have sex with men (MSM) than in the general population. Co-infection with human immunodeficiency virus (HIV) further amplifies this burden, making the rates of anal SCC in HIV-positive MSM higher than the historic rates of cervical cancer prior to the adoption of routine cervical cytology screening. Despite these alarming statistics, there are no established protocols for optimal screening and treatment of anal HPV and cancer precursors, nor has there been any widespread rollout of organized screening programs anywhere in Canada. Further, not only does HPV directly cause significant disease in these men, but there is growing epidemiologic evidence that HPV infection may enhance sexual transmission of HIV. These significant knowledge gaps translate into fundamental deficiencies in care for HIV-positive MSM.

The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team will recruit a large group of MSM from various Ontario and Vancouver clinics, in order to carry out a number of different studies. The HPV-SAVE team brings together community and internationally-recognized experts in HPV and HIV disease and mucosal immunology, to better define the optimal approaches for primary and secondary prevention and treatment of HPV-associated anal disease among HIV-positive MSM, and to explore biological mechanistic evidence regarding the potential role of HPV as a co-factor for HIV transmission. This will yield critical information which can lead to improvement in the health of MSM, and will provide a foundation on which to build further, large-scale screening and treatment trials on a national level. The primary aim of the current study is to systematically compare ablative therapy versus intensive observation alone (also known as 'watchful waiting') in outcomes relating to high-grade anal dysplasia.

Since the 1990s, combination antiretroviral therapy (cART) has markedly reduced HIV-related opportunistic infections and mortality \[1\], and increased the life expectancy of people living with HIV \[2\]. While acquired immune deficiency syndrome (AIDS)-defining malignancies have declined \[3,4\], non-AIDS defining malignancies continue to occur at higher rates in HIV-infected persons than in the general population \[4\]. Amongst these are cancers associated with HPV which is responsible for the vast majority of cervical cancers (itself a well-established AIDS-defining illness), and an estimated 90% of SCC of the anal canal \[5\]. cART not only fails to protect against anal pre-cancers and cancers \[4,6,7\], but the incidence of anal SCC is increasing in the cART era \[6,8\]. Because of this increasing burden of disease, there is an urgent need to find effective ways of preventing anal SCC in those living with HIV. This includes screening for anal cancer precursors and ablative treatment of these lesions.

Though it is infrequent at a rate of 1 per 100 000, anal SCC is on the rise in the general population \[9\]. It occurs at significantly higher rates in HIV-positive men - particularly among men who have sex with men (MSM) - with an estimated rate of 60 to 160 per 100 000 \[4\], and no evidence of slowing in the era of increased cART use \[10\] (See Figure 1). In fact, rates of anal cancer among HIV-infected MSM are comparable to rates of cervical cancer in women prior to the adoption of routine screening for cervical dysplasia \[11\]. According to data from the Public Health Agency of Canada, rates of cervical cancer in 1972 were 18 per 100 000, dropping to just under 8 per 100 000 in 2004 \[12\]. In addition to its etiologic association with HPV, anal cancer shares many similarities with cervical cancer. Both are squamous cell cancers occurring at the squamocolumnar junction \[13,14\] and both likely arise from histologically-similar dysplastic precursor lesions \[15,16\]. It is postulated that a critical step in anal cancer carcinogenesis is the establishment of persistent infection with oncogenic HPV in the anal canal \[16\]. Though the majority of HPV infections are considered transient and will eventually clear even in HIV-positive individuals \[17\], HIV-positive individuals have higher rates of persistent infection, especially with oncogenic HPV types \[18\].

Of the greater than 170 HPV types, over 50 favour the anogenital area and, on the basis of epidemiologic and phylogenetic data, these have been classified by the International Agency for Research on Cancer \[19\]. The vast majority of anal cancers (as well as cervical cancers) are caused by two high-risk HPV types: HPV type 16 and HPV type 18 which are responsible for 66% and 5% of anal cancers, respectively \[20\]. HPV lesions caused by low-risk HPV (LR-HPV) types include condylomata (commonly known as 'genital warts'), of which 90% are caused by HPV types 6 and 11 \[21\]. Prevention strategies for anal cancers have emerged that are analogous to strategies used in cervical cancer screening, in that the aim is to identify precursor lesions which can then be removed before progression to cancer. Screening and detection rely on a combination of anal cytology (Papanicolaou, or Pap smear), anal HPV detection and high-resolution anoscopy (HRA) which is analogous to colposcopy). Visually-directed anal biopsy during HRA is considered the gold standard for detecting dysplastic lesions such as high-grade anal intraepithelial neoplasia (HGAIN; typically graded as AIN-2 or -3) \[16,22\]. Anal cytology is generally used as a screening test to determine whether HRA is needed; however, cytology is an imperfect predictor of intra-anal HGAIN. Despite the clear evidence indicating the benefit of screening and treatment procedures in cervical cancer screening, no large rigorous studies have been performed to assess such strategies in anal cancer prevention in men or women.

The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men

A Randomized Controlled, Open-label Trial Examining the Efficacy, Safety, and Tolerability of Ablative Therapies for High-grade Anal Dysplasia Versus Observation Alone in HIV-positive Men Who Have Sex With Men (MSM)

Histologic resolution of high-grade AIN after treatment completion, with ablative therapies or surveillance alone. Resolution of high-grade AIN will be defined as histologic diagnosis of AIN-1 or normal at the post treatment HRA.

Resolution of high-grade AIN after treatment on a per-lesion basis. Histologic resolution of high-grade AIN after treatment completion, with ablative therapies or surveillance alone. Resolution of high-grade AIN will be defined as histologic diagnosis of AIN-1 or normal at the post treatment HRA.

Recurrence rates of high-grade AIN following ablative therapy on a per lesion basis.

Number of participants assessed on safety, tolerability and acceptability of the different intervention arms and the different treatments in the ablative therapies arms. Evaluation of adverse events and questionnaire-assessed acceptability by intervention arms and ablative treatment type.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy	NCT01683877	Benign Ovarian ...	FloSeal applica... Electrocautery	20 Years -	Asan Medical Center
Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.	NCT00591552	Lung Cancer	Harmonic ACE23P... Electrocautery	20 Years - 75 Years	Sentara Cardiovascular Research Institute
Use of Harmonic in Breast Surgery	NCT01587248	Breast Cancer Modified Radica...	Harmonic electrocautery	16 Years - 80 Years	Aga Khan University
Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System in the Surgical Unit	NCT03924206	Lung Cancer Lung Injury	Smoke evacuatio...	18 Years - 90 Years	Insel Gruppe AG, University Hospital Bern
Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy	NCT01683877	Benign Ovarian ...	FloSeal applica... Electrocautery	20 Years -	Asan Medical Center
The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men	NCT02503111	Anal Dysplasia Human Papilloma... Anal Cancer	The Hyfrecator ... Observation Alo...	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for electrocautery