Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Carcinoma

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

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.

Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.

Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Extraperitoneal Laparoscopic aortic lymphadenectomy

Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Transperitoneal Laparoscopic aortic lymphadenectomy

Antonio Gil Moreno, MD, PhD

Berta Diaz Feijoo, MD, PhD

Alejandro Correa Paris, MD

M. Assumpció Pérez-Benavente, MD, PhD

Silvia Franco Camps, MD

Jose Luis Sánchez Iglesias, MD, PhD

Silvia Cabrera Díaz, MD, PhD

Oriol Puig Puig, MD

Javier De La Torre, MD, PhD

The purpose of this study is to determine whether or not there are more complications in the extraperitoneal compared with the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer

STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer

STELLA 2 Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes, Evaluating Complications

Composite outcome defined by including at least one of the following:

* Total estimated blood loss \> 500 mL during surgery
* Blood transfusion
* Intraoperative complication classified as Dindo grade III or worse, related to the aortic lymphadenectomy
* Early postoperative complication (within 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy
* Late postoperative complication (past 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy
* Conversion to laparotomy during the aortic lymphadenectomy
* Inability to complete the aortic lymphadenectomy

The number of lymph nodes (absolute number) is specified by the pathologist on histopathological analysis of the sample sent by the surgeon after surgical staging is realized (laparoscopic aortic lymphadenectomy). This variable is subdivided into: supra-mesenteric and infra-mesenteric.

Total duration of surgery (from initial skin incision to end of skin suture), and total aortic lymphadenectomy time (time spent since the beginning of aortic lymphadenectomy to its completion). Metric: minutes.

The number of days that patients stay in the hospital after surgery, measured in days from the day of the surgery to the day the patient is discharged from the hospital.

Period of time in which there is no appearance of the symptoms or effects of the disease.

European Regional Development Fund

Hospital Universitari Vall d'Hebron Research Institute

Heart and Blood Diseases

Symptoms and General Pathology

Carcinoma, Renal Cell

Arrhythmias, Cardiac

Kidney Neoplasms

Heart Diseases

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Renal Cell Carcinoma

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Vasoconstrictor Agents

Respiratory System Agents

Anesthetics

Bupivacaine

Fentanyl

Epinephrine

Anesthetics, Local

Racepinephrine

Epinephryl borate

Analgesics, Opioid

Narcotics

Anesthetics, Intravenous

Anesthetics, General

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

Holter ECG monitor General anesthesia Open kidney cancer surgery

Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery

Bupivacaine-fentanyl

Holter ECG monitor

Open kidney cancer surgery

General anesthesia

Epidural Anaesthesia

Karolina Dobronska, MD

This study evaluates the incidence of cardiac arrhythmias during the perioperative period in patients undergoing open kidney cancer surgery in the lateral position. All the participants will be randomly allocated to receive general (Group G) or combined epidural/general anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM)

Cardiac arrhythmias are a common complication during and after cardio-thoracic surgery. They are also a major source of morbidity and mortality. After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete. There is no literature data about their incidence during kidney surgery in the lateral position when the bed is scissored so the legs and head are low. The aim of this study was to define what types of arrhythmias are the most common during kidney cancer surgery, their incidence and whether combining general with epidural anesthesia prevents them.

An approval from the Medical University of Warsaw Bioethical Committee has been obtained. Patients need to give written informed consent to participate in the study.

It is anticipated that 50 patients with open kidney cancer surgery performed in the lateral position, under general or combined anesthesia will be enrolled.

A Holter ECG monitor (3-chanel, leads CM5) will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM).

Patients will be randomly allocated (random permuted blocks within strata) to receive general or combined epidural/general anesthesia. The anesthetic technique is standardized. All the data registered by the Holter ECG monitor will be analyzed and compared with the nursery and anesthesia records.

Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method

Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method

The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them

Arrhythmias observed:

tachycardia \>100 bpm bradycardia \< 50 bpm pause (P-P interval \> 2 seconds) ventricular extrasystoles (VE) \> 1000/ 24 hours supraventricular extrasystoles (SVE) \>200/24 hours

The investigator evaluates the incidence of cardiac arrhythmias depending on anesthesia method by observing the number and type of arrhythmias and whether additional interventions were needed to treat them

Medical University of Warsaw

M.D.

General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position

General Anesthesia (G)

General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position

Combined General/Epidural (G/E)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Poland

Region of Enrollment

AMERICAN SOCIETY OF ANESTHESIOLOGISTASA (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM

ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes

\*The addition of "E" denotes Emergency surgery

Type of Surgery

Dr. Karolina Dobronska

No bradycardia observed in the perioperative period

Tachycardia < 140 bpm before surgery

Tachycardia < 140 bpm during surgery

Tachycardia < 140 bpm after surgery

Bradycardia before surgery

Bradycardia during surgery

Bradycardia after surgery

Bradycardia in the perioperative period

pause > 2s before surgery

pause > 2s during surgery

pause > 2s after surgery

pause > 2s in the perioperative period

SVE before surgery

SVE during surgery

SVE after surgery

SVE in the perioperativ

VE before surgery

VE during surgery

VE after surgery

VE in the perioperative period

Additional intervention needed

General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia

Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period

long QTc \> 0.24 s in the perioperative time

arrhythmia before surgery

arrhythmia during surgery

arrhythmia after surgery

QTc long > 0.45s before surgery

QTc long > 0.45s during surgery

QTc long > 0.45s after surgery

QTc long > 0.45s in the perioperative time

arrhythmias analysed: bradycardia, pause \> 2s, supraventricular extrasystoles, ventricular extrasystoles; corrected QT interval (QTc)

The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed

Overall Study

Transperitoneal laparoscopic aortic lymphadenectomy

Extraperitoneal laparoscopic aortic lymphadenectomy

Antonio Gil Moreno, M.D., PhD

Berta Díaz Feijoo, M.D., PhD

Jose Luis Sánchez, M.D.

Alejandro Correa Paris, M.D.

M. Assumpció Pérez-Benavente, M.D., PhD

Silvia Cabrera Díaz, M.D.

Silvia Franco Camps, M.D.

Oriol Puig Puig, M.D.

The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.

STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer

STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes

Number of patients presenting intraoperative complications. This variable is also classified according to the type of adverse outcome.

Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.

Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease.

Fundación Mutua Madrileña

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer	NCT02676726	Endometrial Neo... Ovarian Neoplas...	Extraperitoneal... Transperitoneal...	18 Years - 85 Years	Hospital Universitari Vall d'Hebron Research Institute
Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method	NCT02988219	Arrhythmia, Car... Kidney Cancer Surgery Anesthesia, Loc...	Bupivacaine-fen... Holter ECG moni... Open kidney can... General anesthe... Epidural Anaest...	18 Years -	Medical University of Warsaw
STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer	NCT01810874	Endometrial Neo... Ovarian Neoplas...	Transperitoneal... Extraperitoneal...	-	Hospital Universitari Vall d'Hebron Research Institute
STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer	NCT01810874	Endometrial Neo... Ovarian Neoplas...	Transperitoneal... Extraperitoneal...	-	Hospital Universitari Vall d'Hebron Research Institute

Spots Global Cancer Trial Database for extraperitoneal