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Laparoscopy clinical trials

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NCT ID: NCT05495217 Active, not recruiting - Laparoscopy Clinical Trials

A Clinical Study for Comparison of the Effects Between Gasless Laparoscopy and Conventional Laparoscopy for Distal Gastric Cancer

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

The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0).

NCT ID: NCT05363813 Active, not recruiting - Laparoscopy Clinical Trials

Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery

RELAP
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

This is a Post-Market Clinical Follow-up (PMCF) investigation to determine the long-term effectiveness and safety of the Multi-Fire Clip System in laparoscopic surgery. This system consists of two medical devices, the M/L-10 Clip Applier and the M/L-10 Clip. The Multi-Fire Clip System is indicated for occluding and ligating vessels, ducts, tracts and other tubular structures during laparoscopic and general surgical procedures. This medical device has been marketed in Europe since 2006 and in the United States since 2002, among other places. Laparoscopic surgeries have become the standard of excellence for many surgical procedures as they allow the intervention to be performed in a minimally invasive way, which means significant improvements in factors such as postoperative pain or length of hospital stay compared to open surgeries. Laparoscopic procedures require the use of different hemostatic techniques to minimize blood loss or leakage of other fluids through their respective ducts. Currently, clip and staple placement are the most commonly used procedures for ligation and/or occlusion of blood vessels and other tubular structures. In this context, the Multi-Fire Clip System is presented as an alternative device that can produce significant cost savings due to the reusable design of the M/L-10 Clip Applier. It also provides precise control of bleeding during surgery, which could lead to less potential injury to surrounding structures. The present clinical trial is a PMCF study to evaluate the long-term safety and efficacy of the Multi-Fire Clip System in patients scheduled to undergo laparoscopic surgery in which clip placement is anticipated. During the surgery procedure, the necessary clips will be placed using the aforementioned multi-shot clip system. Participants will be followed up for 6 months after the operation. Through an on-site visit and a telephone call visit, data on possible adverse events related to the device or procedure will be collected in order to assess the long-term safety and efficacy of these devices.

NCT ID: NCT05302622 Active, not recruiting - Laparoscopy Clinical Trials

Detecting the Most Efficient Residency Time for Laparoscopic Simulators

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

Laparoscopic surgeries is one of the most common surgery in gynecologic procedures. Nowadays there are many laparoscopic simulators for training residents. In this study it is aimed to determine the most efficient residency year for laparoscopic simulators. This study planned as a prospective study. There will be three group which include ob/gyn residents. The residents will choose based on their residency year and surgery skills. 1. The residents who makes surgeries both laparoscopic and laparotomic, 2. The residents who makes surgeries only laparotomic, 3. The residents who won't any gynecologic surgery The data of surgery time, complications and movement numbers will take from the simulator. Tubal ligation and salpingooferectomy choose for the surgery examples. The simulation results of participants will compare and try to find the best improvement term for residency.

NCT ID: NCT05019612 Active, not recruiting - Endometriosis Clinical Trials

The Role of Expectations on Complaints and Well-being After Endometriosis Surgery in Women

ROXWELL
Start date: August 25, 2021
Phase:
Study type: Observational

Endometriosis is a prevalent disease in women of procreative age. Most endometriosis patients are affected in their daily life by complaints such as chronic pelvic pain, dysmenorrhoea, infertility, or pain during sexual intercourse. Yet, its etiology is poorly understood. Although laparoscopy is well known as the gold standard for treating endometriosis, 20-30% of treated women still show persistent complaints following successful laparoscopy. It has been widely recognized that expectations profoundly affect treatment courses and outcomes in many different health conditions. Additionally, evidence suggests that optimizing preoperative expectations can improve post-operative outcomes such as disability and return to work. The objective of this study is to investigate whether expectations also affect treatment course and outcome in women after endometriosis surgery. For this purpose, the investigators conduct a mixed-method observational cohort study to gather data on psychological factors, particularly treatment and symptom-related expectations, as well as complaints and well-being of patients after surgery. A sample of N = 300 women will be asked pre- and postoperatively to evaluate these psychological factors and indicators of treatment course and outcome. Overall, the study will last 12 months, including one assessment preoperatively (baseline), seven monthly assessments postoperatively, and a follow-up assessment 12 months after endometriosis surgery. The study aims to determine potential interactions between aforementioned psychological factors, their influence on the postoperative health, and the long- and short-term symptom course of patients with endometriosis. The study results will provide a better understanding of the symptom- and treatment course in women with endometriosis and subsequently supply clinical approaches to optimize treatment of endometriosis.

NCT ID: NCT03860805 Active, not recruiting - Laparoscopy Clinical Trials

SALpingectomy for STERilization (SALSTER)

SALSTER
Start date: April 3, 2019
Phase: N/A
Study type: Interventional

The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function.

NCT ID: NCT03430609 Active, not recruiting - Laparoscopy Clinical Trials

Ovarian Function After Use of Various Hemostatic Techniques During Treatment for Endometrioma

Endometrioma
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Background: Endometriosis is defined by the presence of endometrial tissue outside the uterine cavity due to causes not yet fully elucidated. The disease affects approximately 2% of women of reproductive age and is associated with infertility. Approximately 17% to 44% of women with endometriosis exhibit endometrioma, or ovarian endometriosis. Laparoscopic cystectomy is currently considered the gold standard treatment for this problem, resulting in improvement of symptoms, a lower recurrence rate and a higher pregnancy rate among infertile patients. However, several studies have shown that this treatment is not free from risks because it is associated with reduction of the ovarian reserve due to accidental removal of ovarian cortex during stripping of the capsule or damage caused by the coagulation energy during hemostasis, even when performed by experienced surgeons. There is still controversy in the literature as to the cause of the reduction of the ovarian reserve, as the mere presence of endometrioma reduces ovarian function by itself. The aim of this study is to compare the effects of different hemostatic methods on the ovarian function of women subjected to laparoscopic surgery for ovarian endometrioma. Methods: Open-label randomized clinical trial to be conducted at Lauro Wanderley University Hospital from September 2017 to August 2020. Eighty-four patients will be randomly allocated to three groups according to the hemostatic technique used during laparoscopic surgery for ovarian endometrioma: bipolar coagulation, laparoscopic suture and hemostatic matrix. Ovarian function will be assessed by measuring serum anti-Mullerian hormone and follicle-stimulating hormone levels and by ultrasound antral follicle counts before surgery and 1, 3 and 6 months after surgery. The study was approved by the research ethics committee at the Medical Sciences Center, Federal University of Paraíba CAAE no. 71621717.9.0000.8069. Discussion: The present study intends to assess the ovarian function of patients with endometrioma subjected to laparoscopic surgical treatment, comparing different hemostatic techniques like bipolar coagulation versus suture versus hemostatic matrix with objective assessments of bipolar coagulation to avoid bias. Thus, the investigators expect to contribute data likely to dispel doubts on the subject.

NCT ID: NCT01043835 Active, not recruiting - Laparoscopy Clinical Trials

Comparison of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer:A Prospective Randomized Trial

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the short- and long-term results between the laparoscopy-assisted gastrectomy and the open gastrectomy.