Altındağ, Turkey
Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy
The aim of this study is to asses validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors
Phase
N/ASpan
102 weeksSponsor
Mansoura UniversityRecruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
NECO2 is a pilot trial, evaluating the intermediate effectiveness to short/medium term of laparoscopy on the inflammatory reaction of premature newborns with complicated ECUN, requiring surgical treatment. This is a multicenter randomized controlled trial in single blind, in two parallel arms, in ratio 1:1, of superiority. This trial compares laparoscopy plus laparotomy versus laparotomy alone. Children will be randomized into 2 groups: - Laparoscopy + laparotomy group - Laparotomy group The main objective is to evaluate the inflammatory response Day 2 postoperative in preterm infants with ECUN who have undergone surgery. The main criterion is the evolution of the blood C reactive protein level between Day 0 and Day 2 postoperatively. The secondary objectives are:To evaluate in premature babies with ECUN who have had a surgical intervention (laparoscopy + laparotomy or laparotomy alone): A.The postoperative biological inflammatory response at Day 7 B.Post-operative biological inflammatory response from Day 0 to Day 7 C.Post-operative mortality D.Post-operative bowel morbidity E.Post-operative re-intervention rate F.Length of hospital stay G.Post-operative neurological morbidity, medium term (corrected term 41 SA) - To evaluate the tolerance of laparoscopy : H.Intraoperative cardiorespiratory I.Loco-regional lesions linked to the insertion of the trocar Secondary endpoints: A. C reactive protein blood level at Day 7 B. Blood levels of Procalcitonin, Interleukin 6 and Tumor Necrosis Factor-alpha at Day 1, Day 2, Day 4, Day 7 C. Postoperative death from any cause D. Stoma rate, duration of parenteral nutrition, duration of hemodynamic support, duration of invasive ventilation (High frequency oscillatory ventilation/Synchronized Intermittent Mandatory Ventilation), Post-ECUN intestinal stenosis rate E. Re-intervention (laparotomy) and cause (post-ECUN stenosis, stoma closure) F. Length of hospital stay until return home G. Early postoperative neurological lesions observed on transfontanellar ultrasound and MRI at the corrected term of 41 weeks of amenorrhea, H. Oxygen saturation (SaO2), hypercapnia (pCO2) blood pressure (BP), cerebral oxygenation (Near InfraRed Spectroscopy (NIRS)) intraoperatively I. Intraoperative clinical monitoring: exploration of adjacent organs. Post-operative clinical monitoring: digestive signs monitoring of wounds until discharge. Group 1: laparotomy only Group 2: laparotomy and laparoscopy
Phase
N/ASpan
84 weeksSponsor
Assistance Publique - Hôpitaux de ParisRecruiting
TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)
Phase
N/ASpan
183 weeksSponsor
University Hospital, Clermont-FerrandRecruiting
Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
Phase
N/ASpan
186 weeksSponsor
University Hospital, Clermont-FerrandRecruiting
Healthy Volunteers
Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma
Phase
N/ASpan
263 weeksSponsor
Assistance Publique - Hôpitaux de ParisRecruiting
A Study of Second Look Laparoscopy (SLL) in People With Ovarian Cancer Who Have Completed Their First Course of Chemotherapy
Phase
2Span
106 weeksSponsor
Memorial Sloan Kettering Cancer CenterRecruiting
Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
This is a double-blinded, parallel (1:1) group, randomized-controlled, superiority trial. Patients will be blinded to their treatment allocation and will understand that by entering the study, they may receive diagnostic laparoscopy only in which case their mesh will not be removed. However, they will be allowed to consider crossing over to the mesh removal group 6 months or later after surgery if they do not have adequate pain relief. Patients will receive written and oral descriptions of the trial and will be provided time to review written documentation in private. Written and oral consent will be obtained, and patients will understand that their participation is voluntary and refusal to participate will not affect future medical care. Patients may also withdraw from the trial at any point throughout the study period. The Cleveland Clinic Center for Abdominal Core Health, a center within the Digestive Disease and Surgery Institute (DDSI), at Cleveland Clinic Foundation Main Campus in Cleveland, Ohio is the hosting department for this study. Cleveland Clinic - Hillcrest Hospital in Mayfield Heights, Ohio will also be a participating center in this study. Fellowship-trained surgeons with expertise in complex abdominal wall reconstruction and mesh removal will perform the operations. If enrollment fails to meet necessary accrual size within the study timeframe, additional centers may be invited to participate.
Phase
N/ASpan
180 weeksSponsor
David KrpataRecruiting
Healthy Volunteers
A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest
Participants in this research study, may or may not have a tumor within a urologic region of interest such as the bladder, prostate, testicle, kidney, urethra, and penis which may or may not have spread to a lymph node and have been scheduled to undergo a lymph node dissection procedure and/or organ removal surgery within one of the previously mentioned urologic regions of interest concerning for urologic cancer. This research study involves the use of a standard of care laparoscope and ultrasound probe. The laparoscope and ultrasound probe will have an electromagnetic sensor attached which will assist in the tracking of lymph nodes of interest or organs of interest. It is expected that the entire time to record the data will be less than 10 minutes. A total of 10 people will take part in this research study This study is supported by Siemens Medical USA.
Phase
N/ASpan
174 weeksSponsor
Dana-Farber Cancer InstituteRecruiting
Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses
Pelvic inflammatory diseases (PID) require antibiotic treatment. Among PID, the investigators distinguish: pelvi-peritonitis and pelvic collections such as Douglas abscess and/or tubo-ovarian abscess (TOA). Recent recommendations published in December 2018 by the National College of French Gynecologists and Obstetricians (CNGOF) suggest that it is preferable to drain TOA when their size is greater than 3-4 cm. Ultrasound-guided transvaginal drainage is recommended as first-line treatment because of its ease of performance and its effectiveness. In the literature, many authors have demonstrated the feasibility and efficacy of transvaginal drainage associated with antibiotics in the treatment of TOA. Since ultrasound-guided transvaginal drainage is a less invasive alternative therapeutic procedure than laparoscopy for the drainage of TOA, it would be compatible with outpatient management. This mode of management can be carried out in a dedicated outpatient or functional exploration room with the help of a nurse but without an anesthetic team present. This gesture is simple and short-lived. In addition, the antibiotics used have pharmacological properties allowing oral intake from their initiation. The investigators have proposed a new service protocol to treat TOA in this outpatient mode. The investigators therefore wish to analyze this new protocol from these three angles: 1/ the feasibility of this care, 2/ the quality of life of the patients through questionnaires given throughout the care and 3/ an evaluation of the 'efficiency.
Phase
N/ASpan
125 weeksSponsor
Nantes University HospitalRecruiting
Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?
Phase
N/ASpan
231 weeksSponsor
University of AarhusRecruiting