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NCT ID: NCT05206279 Recruiting - Laparoscopy Clinical Trials

ICG for Visualization of the Ureters in DIE

Lavic
Start date: June 26, 2023
Phase: N/A
Study type: Interventional

Endometriosis is a common condition with an incidence of approximately 10% of all women in the fertile phase. Deep infiltrating endometriosis (DIE) has been shown to be associated with high morbidity. A retrospective study of 700 patients has shown lower urinary tract involvement in up to 52.6% of cases with DIE. In most studies, the bladder is cited as the most common site of DIE in the urinary tract, with the ureter being the second most common lesion site. In cases of ureteral endometriosis, a procedure called ureterolysis is essential because complete resection of the endometriosis is necessary to resolve or prevent renal obstruction. In addition, ureterolysis is obligatory in the context of dissection of endometriosis involving the rectovaginal septum, sacrouterine ligaments, or rectum. Ureterolysis is the process of freeing the ureter from both endometriotic nodules as a therapeutic procedure and from physiologic surrounding tissue and structures for complete visualization. Because ureterolysis is a high-risk procedure for ureteral lesions, alternatives are desirable. ICG is a fluorescent dye that has been used for decades for various indications, including retinal angiography, determination of tissue viability, and testing of cardiac and liver function. It has gained an important role in intraoperative visualization of tissue perfusion as well as sentinel lymph nodes in tumor surgery. ICG has also been used and described for ureteral imageability. However, these studies included small populations of 10-30 patients. None of the aforementioned studies have investigated the imageability of the ureters in endometriosis and with regard to a possible reduction in the need for ureteral dissection. The investigators perform a cystoscopy with a retrograde injection of ICG in both ureters. ICG and thus the ureters are visualized during laparoscopy by near-infrared light contained in our camera systems. The additional use of fluorescence imaging of the ureters with ICG injected into the ureters during laparoscopic resection of deep infiltrating endometriosis is intended to improve visualization of the ureters and thus may prevent complete ureterolysis, which is considered a high-risk procedure. It is a safe procedure as ICG has been shown to have an excellent safety profile. The aim of the study is to prove the feasibility of ureteral visualization using intraureteral ICG in 2D laparoscopy for women with deep infiltrating endometriosis by means of near-infrared fluorescence imaging of the ureters. In our secondary endpoints the investigators want to describe the duration time of ICG injection, the duration until visualization of the ureters, the detection rate of fluorescing ureters after ICG-injection, the duration until maximum fluorescence is achieved, the duration until the ureters can no longer be displayed, the length of performed ureterolysis in centimeters and the safety of intraureteral ICG injection.

NCT ID: NCT05169073 Recruiting - Virtual Reality Clinical Trials

Virtual Reality Training for Laparoscopic Cholecystectomy

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

Cholecystectomy is one the most frequent laparoscopic procedures worldwide. It is a safe and effective operation but intraoperative bile duct injury remains a relevant complication with serious consequences for the patient. Most of the complications occur due to a lack of knowledge of the anatomy or misidentification of the cystic duct. Thus, the study of the anatomy is a cornerstone of a successful procedure and the preoperative magnetic resonance cholangiopancreatography (MRCP) is a way to preoperatively determine relevant structures to avoid intraoperative incidents. This trial has been designed to assess the effect of preoperative virtual reality training based on MRCP on intraoperative performance and outcome.

NCT ID: NCT05031182 Recruiting - Laparoscopy Clinical Trials

Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.

VLAP
Start date: October 11, 2021
Phase: N/A
Study type: Interventional

During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.

NCT ID: NCT04643314 Recruiting - Laparoscopy Clinical Trials

Effect of Video-based Guided Self-reflection on Intraoperative Skills

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

While video-assisted structured feedback by expert surgeons significantly improves laparoscopic skill acquisition in surgical trainees, this method is resource intensive and may have limited feasibility outside of research settings. Self-assessment and reflection are integral parts of medical experiential learning; however the value of video-based self-reflection in enhancing surgical skill acquisition remains to be determined. The objective of the proposed pilot study is to investigate the feasibility of conducting a full-scale randomized controlled trial (RCT) aimed to evaluate the effectiveness of coached video-based self-reflection approach on surgical trainee performance of laparoscopic cholecystectomy.

NCT ID: NCT04539080 Recruiting - Nerve Block Clinical Trials

Heart Rate Variability and Electroencephalography Analysis in Laparoscopic Surgery With or Without Transversus Abdominis Plane Block

Start date: August 30, 2020
Phase:
Study type: Observational

Heart rate variability(HRV) and electroencephalography(EEG) has been used widely in anesthetic practice nowadays. One of the most dominant applications is the nociception-analgesia balance. Some evidence support that heart rate variability correlates with perioperative stimulation and postoperative pain score. There are some new evidence support EEG correlated with anesthesia depth and analgesic balance. However, the heterogeneity between the studies and interference factors has limited their usage in clinical practice. On the other hand, peripheral nerve block is broadly used as a routine technique with general anesthesia, but few studies discuss the effect on heart rate variability. Our study focuses on the different HRV and EEG patterns of incision and insufflation during laparoscopic surgery with general anesthesia. Furthermore, we measure the effect of transversus abdominis plane nerve block to heart rate variability during surgery. By this comparison, we can discuss the influences of somatic stimulation, visceral stimulation, and pneumoperitoneum to heart rate variability, and then improve the accuracy of HRV-based nociception-analgesia monitors.

NCT ID: NCT04269226 Recruiting - Obesity, Morbid Clinical Trials

Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics of Obese Laparoscopic Abdominal Surgery Patients

Start date: April 9, 2019
Phase: N/A
Study type: Interventional

This study aims to demonstrate the effects of automatic recruitment maneuver on peroperative lung mechanics of obese patients undergoing laparoscopic abdominal surgery. 128 obese patients undergoing abdominal laparoscopic surgery are randomly going to be assigned to automatic recruitment maneuver group and no recruitment maneuver group (control group). Both groups are going to be taken to the operating table. Electrocardiography (ECG), noninvasive blood pressure (NIBP), pulse oximeter and peripheral oxygen saturation (SpO2) and post-intubation end-tidal carbon dioxide (EtCO2) and train of four (TOF) monitoring will be performed. Then, general anesthesia induction procedure will be started. Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal PEEP (Positive end-expiratory pressure) for the patient, and PEEP (Positive end-expiratory pressure) will be adjusted at this value after recruitment. If MAP (mean arterial pressure) is <60 mmHg during the maneuver, the maneuver will be terminated and these patients will be excluded from the study. Respiratory mechanics for both groups (peak pressure, plateau pressure, driver pressure, static compliance, dynamic compliance, EtCO2) and hemodynamic parameters (heart peak, mean arterial pressure, SpO2) at 5 different times (T1: post intubation; T2 : after insufflation; T3: 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver) will be recorded. Throughout the surgery, insufflation pressure will be kept as 10-13 cmH20. At the end of the surgery, the anesthesia maintenance of all patients will be terminated and the routine wake-up phase will be initiated. Creatinine values and hourly urine outputs of all patients routinely monitored at the postoperative 24th hour will be recorded on the case follow-up form.

NCT ID: NCT04070872 Recruiting - Laparoscopy Clinical Trials

3-dimensional Versus 2-dimensional Laparoscopy for Hysterectomy

Start date: August 23, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic hysterectomy.

NCT ID: NCT04070716 Recruiting - Laparoscopy Clinical Trials

3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy

Start date: August 23, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic myomectomy..

NCT ID: NCT03963882 Recruiting - Laparoscopy Clinical Trials

NAC Followed by RH for the Treatment of LACC

Start date: June 19, 2019
Phase: Phase 2
Study type: Interventional

This cohort study is to evaluate the role of neoadjuvant chemotherapy (NAC) in the treatment of locally advanced cervical cancer (LACC). Sixty patients with LACC (FIGO 2009 stage IB2 to IIB) will be enrolled. After informed consents, they would accept the imaging evaluation of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET). After excluding cases of distant metastasis, they will accept two cycles of NAC (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). Then a second MRI is performed to evaluate the imaging response. For patients achieving objective response, radical hysterectomy (RH, via laparoscopy or laparotomy) and an evaluation of pathologic response are performed. For patients without objective imaging response, the choice of concurrent chemoradiotherapy or radical hysterectomy will be discussed. After RH, adjuvant therapy will be given according to the RH pathologic results. The primary objectives consist of (1) the objective imaging response after NAC; (2) the objective pathologic response after RH. The secondary objectives consist of (1) disease-free survival and overall survival after various therapy modalities; (2) severe adverse effects of NAC; (3) the effects of NAC on the surgical outcomes.

NCT ID: NCT03792932 Recruiting - Pancreatic Cancer Clinical Trials

Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer

Start date: February 2, 2019
Phase: N/A
Study type: Interventional

Open distal pancreatectomy (ODP) has been commonly employed for the treatment of a variety of cancers in body and tail of pancreas. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had not been performed for its complicated anatomy. But laparoscopic distal pancreatectomy (LDP) has been widely accepted as a standard treatment for body and tail pancreatic cancer because there is no anastomosis in it, and LDP has gradually become the first choice for these cancers in clinical work. Although there are several studies about the comparison between LDP and ODP, most are retrospective and there is no agreement in surgical margin, lymph node numbers and prognosis to identify the oncological differences between the two surgical approaches. The investigators' pilot study showed that patients with body and tail pancreatic cancer underwent LDP had a better prognosis compared with the ones undergoing ODP, with no statistics differences in postoperative complications and mortality. This perspective RCT study is performed to confirm whether LDP would improve the prognosis for patients with body and tail pancreatic cancer compared with ODP.