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NCT ID: NCT04167072 Withdrawn - Clinical trials for Cholecystitis, Acute

Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

The study will compare the outcomes of patients with gallstone related cholecystitis who are poor surgical candidates undergoing EUS guided cholecystoenterostomy via a lumen apposing metal stent (LAMS).

NCT ID: NCT04113590 Withdrawn - Cholelithiasis Clinical Trials

Laparoscopic Assisted Transvaginal Cholecystecomy

Start date: August 2011
Phase: N/A
Study type: Interventional

Laparoscopic cholecystectomy is currently the standard procedure for removing the gallbladder. This procedure usually requires the insertion of four trocars into the abdomen for passage of laparoscopic instruments; each trocar requires a small incision, which results in postoperative pain and scarring. There has recently been a tremendous surge in interest within the surgical community to further reduce the pain, invasiveness, and cosmesis of laparoscopic surgery. To achieve this goal, surgeons are either reducing the number of trocars placed through the abdominal wall or eliminating them completely The goal of this project is to evaluate the feasibility of performing transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. This has the potential to decrease postoperative pain, improve cosmesis, and lead to a shorter recovery following cholecystectomy.

NCT ID: NCT03530241 Withdrawn - Clinical trials for Gall Stones, Common Bile Duct

Fluorescent Cholangiography and Bile Duct Stones

Start date: March 25, 2019
Phase: N/A
Study type: Interventional

Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile duct stones and is the gold standard. There are no studies describing the sensitivity and specificity of IFC for bile duct stone detection. Research question. What is the sensitivity of IFC to visualize bile duct stones? Method. Prospective study with 40 patients undergoing planned laparoscopic cholecystectomy with preoperative magnetic resonance cholangiopancreatography (MRCP) (gold standard) and intraoperative IFC, X-ray cholangiography and choledochuscopy in that order. Primary outcome. Sensitivity of visualization of bile duct stone by fluorescent cholangiography and secondary outcome is visualization of anatomy.

NCT ID: NCT02056678 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA

Start date: February 2014
Phase: Phase 4
Study type: Interventional

The objective of this study is to determine if IV acetaminophen administered intraoperatively can decrease the dose of narcotics required for adequate pain control and shorten recovery time in the PACU specifically in obese patients at risk for obstructive sleep apnea.

NCT ID: NCT01232959 Withdrawn - Gallstones Clinical Trials

Feasibility of Transvaginal Cholecystectomy

TVC
Start date: October 2010
Phase: N/A
Study type: Interventional

Today there are three different ways to remove a gallbladder with gallstones. Surgeons can remove the gallbladder through small incisions in the abdomen. This is called laparoscopic cholecystectomy. It is the current standard. It has replaced traditional open gallbladder surgery. Open gallbladder surgery is done with a large incision. A new way of removing the gallbladder in women is through the vagina. This is called transvaginal cholecystectomy. This study is being done to see if removing the gallbladder through the vagina will work for patients at Mayo Clinic Rochester. This is the first step of this research to test the procedure. In the future, other studies will examine the potential for less scarring and reduced pain. In this study the investigators will still make small incisions in the abdomen, they will be smaller than the standard procedure but you will still have some scars on your abdomen. Some very early research reports say that some patients may have less pain with the transvaginal approach; however, the investigators do not know if the transvaginal route will have any effect on your overall health and quality of life. This study will evaluate: - Effectiveness of the surgery: ability to remove the gallbladder safely - Effect of the operation on your body: change in pulse and blood pressure during the surgery, level of inflammation markers in your blood before and after the surgery - Recovery from surgery in the hospital: how much pain you have, how much pain medication you need, how long you need to stay in the hospital, or nature of any surgical complications (problems) - Overall recovery from surgery: general quality of life, abdominal symptoms What is the new type of surgery? The new type of surgery is called transvaginal cholecystectomy: A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina.

NCT ID: NCT01146184 Withdrawn - Pain Clinical Trials

Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)

IRB#08-181
Start date: November 2009
Phase: N/A
Study type: Interventional

The aim of this study is to improve the technique of laparoscopic cholecystectomy by using a flexible endoscope passed through a single umbilical skin incision, as previously reported, now with the use of Manually Articulating Devices (Ethicon Endo-Surgery, Inc.) through the endoscope.

NCT ID: NCT01039129 Withdrawn - Appendicitis Clinical Trials

Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Start date: December 2009
Phase: N/A
Study type: Interventional

The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.

NCT ID: NCT01010685 Withdrawn - Gallstones Clinical Trials

Safety Study of Keyhole Gallbladder Surgery With Removal of Gallbladder Via the Stomach Rather Than Through the Skin

Start date: December 2009
Phase: N/A
Study type: Interventional

The benefits of laparoscopic ("minimally invasive" or "keyhole") surgery for gallbladder removal (cholecystectomy) over open surgical procedures in terms of significant reductions in pain, scarring and recovery time are well accepted. In a conventional laparoscopic cholecystectomy however, the excised gallbladder still has to be extracted through the abdominal wall skin via a laparoscopic port site using an incision of 10mm or greater. Despite being much smaller than that required for open surgery, this incision is painful, leaves a scar and can result in a port site hernia to follow requiring further surgery to repair it. Recent attempts to further reduce the invasiveness of the surgical procedure have suggested performing the operation via an endoscope passed through the mouth and through an incision in the stomach wall - so called Natural Orifice Translumenal Endoscopic Surgery (NOTES). Unlike a skin incision, an incision in the wall of the stomach (gastrotomy) should give no pain, visible scar or herniation risk yet still allow access to the peritoneal cavity for surgical procedures such as cholecystectomy. Against this, it has the potential risks of contamination and leakage of gastric contents into the peritoneal cavity. Whilst the limitations of present technology make it very difficult to perform an entire cholecystectomy through the stomach wall in patients, endoscopic methods for closing a gastrotomy are available that are approved for use in patients (CE marked) and it is hypothesised that removing the excised gallbladder through the stomach in this way would avoid the problems of extracting it through the abdominal wall described above. Data are required to determine whether the extraction of the gallbladder via a gastrotomy rather than through the skin is safe, producing smaller scars and a better cosmetic result. A secondary endpoint would be to assess possible reductions in pain and recovery from this less invasive approach.

NCT ID: NCT00815438 Withdrawn - Cholecystitis Clinical Trials

Transvaginal Cholecystectomy Using Endoscopic Assistance

Start date: January 2009
Phase: Phase 1
Study type: Interventional

Surgical removal of the gallbladder is needed in 1 million people per year in the USA. The procedure is done by placing four tubes (cannula) from 5 to 10 mm through the abdominal wall. Air is placed in the abdominal cavity and a lighted scope is placed through one cannula. The space in the abdominal cavity can then be seen on a video screen. Thin retractors and dissecting instruments are placed through the other cannula and the gallbladder is removed using the video screen for vision. The gallbladder duct and the artery are usually occluded with clips or stitches. In this study we propose to do the procedure though a single 5 mm incision placed at the umbilicus and a second access through the vagina using a flexible endoscope. The gallbladder will be retracted using strings (sutures) attached to the gallbladder. The dissection will be done using laparoscopic instruments (scissors, knives, dissectors) placed through the laparoscopic port. A flexible grasper may be used in the endoscope to help with retraction. An endoscopic snare or grasper will be used to grasp the gallbladder and remove it from the abdomen through the vagina. This study evaluates the ability to do laparoscopic cholecystectomy with one skin incision and one vaginal incision. This will provide the basis for future studies evaluating decreased pain and costs with transvaginal assisted cholecystectomy.

NCT ID: NCT00460980 Withdrawn - Gallstones Clinical Trials

Effect of Virtual Reality Training by Novices on Laparoscopic Cholecystectomy in a Porcine Model

Start date: May 2006
Phase: N/A
Study type: Interventional

This study proposes evaluation of an educational tool, a laparoscopic virtual reality simulator. The purpose of this study is to determine whether training on the LapSim Simulator transfers to improved laparoscopic cholecystectomy operative performance in an animal model.