Treatment Trials

47 Clinical Trials for Various Conditions

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RECRUITING
Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Description

The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.

RECRUITING
Feasibility and Utility of Artificial Intelligence (AI) / Machine Learning (ML) - Driven Advanced Intraoperative Visualization and Identification of Critical Anatomic Structures and Procedural Phases in Laparoscopic Cholecystectomy
Description

The goal of this study is to evaluate the utility and efficacy of an artificial intelligence (AI) model at identifying structures and phases of surgery compared to traditional white light assessment by trained surgeons. Surgeons will perform the procedure in their standard practice, while the AI model analyzes data from the laparoscopic camera. Surgeons will be asked to audibly state when they identify structures and enter different phases of the surgical procedure. The AI will not alter the surgeon's view or be visible to the surgeon, and the surgeon will perform the procedure in the exact same fashion as they typically do.

TERMINATED
SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
Description

This is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using SPY fluorescence imaging and ICG, with each surgery also providing a white light 360 degree images. The primary objective is to determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG: and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.

Conditions
COMPLETED
Laparoscopic Cholecystectomy Care Protocol
Description

The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol.

UNKNOWN
Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS
Description

This post-market clinical study is designed to evaluate the effectiveness of the Ultravision™ System when compared to the Airseal® iFS within an approved indication for use, namely laparoscopic cholosystectomy.

WITHDRAWN
Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic Cholecystectomy
Description

This research is being done to examine which minimally invasive surgical approach is associated with the best outcomes when performing cholecystectomy surgery: laparoscopic or robotic? Laparoscopic and robotic approaches are similar surgical procedures using small incisions. The laparoscopic approach is largely used for the removal of the gallbladder (cholecystectomy). At UIC, the investigators perform the majority of the gallbladder surgeries through the robotic approach and only a few using the laparoscopic approach. The robotic surgical tools allows the surgeon the same freedom of movement as a human wrist, while using a 3D camera view. The laparoscopic and robotic surgical approaches both represent minimally invasive surgery approach and are associated with less pain, faster recovery and better cosmetic outcomes when compared to traditional open surgery. It is not currently known which approach is better.

COMPLETED
Nerve Blocks vs Local Injections for Post-op Pain Prevention in Laparoscopic Cholecystectomy in Children
Description

The objective of this study is to compare transversus abdominis plane (TAP) blocks to local wound infiltration (LWI) in terms of postoperative pain control in pediatric patients undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be superior to LWI for postoperative pain control resulting in decreased use of opioid / narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative period. The rationale is that determining the effect of analgesia in this pediatric population is important to optimize clinical care.

WITHDRAWN
Efficacy of Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy
Description

Laparoscopic cholecystectomy is associated with considerable postoperative pain and surgeon-administered local anesthetic infiltration is the standard practice for achieving post-operative analgesia. However, recent studies have shown that pediatric patients continue to experience significant pain during the first 24 hours. The investigators plan to conduct a prospective, double-blinded, randomized study where patients will be designated into either a test group receiving an ultrasound-guided transversus abdominis plane (TAP) and rectus sheath (RS) blocks with ropivacaine and peri-portal sterile saline or the control group that will receive ultrasound-guided TAP block with sterile saline and peri-portal infiltration of ropivacaine. The anesthesia team and surgical team will both be blinded as well as the research personal in the postoperative period. Patients age 5-17 and American Society of Anesthesiology status I and II undergoing laparoscopic cholecystectomy will be included. The study hypothesis is that ultrasound-guided peripheral nerve blocks, specifically single shot transversus abdominis plane and rectus sheath blocks, are superior to local wound infiltration during laparoscopic cholecystectomy for decreasing postoperative pain and pain related behavior and facilitating functional recovery.

COMPLETED
Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy
Description

This is a prospective, double-blinded, randomized controlled study comparing the efficacy of trans-incisional rectus sheath block to laparoscopic guided rectus sheath block for pediatric single-incision laparoscopic cholecystectomy (SILC). umbilical hernia repair in children. Patients aged 10-21 years old undergoing SILC for cholelithiasis, cholecystitis, or biliary dyskinesia will be screened for study inclusion. Eligible patients and their parents/guardians will be approached and, if agreeable, consented for the study pre-operatively. Patients will be randomized to receive either trans-incisional rectus sheath block or intra-operative rectus sheath block under direct laparoscopic visualization. Both will be done by the attending pediatric surgeon. The patient, patient guardians, select research team members, and Post anesthesia care unit (PACU) staff will be blinded to the method of analgesic administration.

UNKNOWN
Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia
Description

The goal of this study is to challenge the existing clinical practice of employing laparoscopic cholecystectomy as the treatment for gallbladder dyskinesia by comparing it to a regimen of active non-surgical therapy.

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

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.

COMPLETED
Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
Description

Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy

COMPLETED
Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin
Description

Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy operation. The appearance of burns are common following laparoscopic cholecystectomy; particularly at the port site of the active electrode. Willson et al found that 9 out of 19 skin biopsies from the skin adjacent to the port site of the monopolar instrument's active electrode were found to have thermal injury by histology. \[Willson et al. Surg Endosc (1997) 11:653\] Authors have speculated that using different generator modes may lead to less capacitive coupling; \[Wu et al Am J Surg (2000) 179: 67\] although no data exists to support these speculations. The investigators hypothesize that capacitive coupling electrosurgical injuries from monopolar instruments are occurring during laparoscopic cholecystectomy operations. The investigators hypothesize that use of blend modes will reduce the incidence of capacitive coupling thermal injuries during laparoscopic operations in comparison to coag modes.

COMPLETED
The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy
Description

The purpose of this study is to evaluate whether a fluorescent die and a special infrared camera can assist with the identification of the important structures during laparoscopic cholecystectomy. This finding may assist surgeons to perform laparoscopic cholecystectomy in less time and in a safer fashion than standard laparoscopic cholecystectomy.

COMPLETED
Pain After Laparoscopic Cholecystectomy With Bilateral Tranversus Abdominis Plane (TAP) Block Versus Local Anesthetic Infiltration
Description

The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy. Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

TERMINATED
Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy
Description

This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.

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

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.

COMPLETED
Pain After Laparoscopic Cholecystectomy
Description

To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less postoperative pain in the first 24 hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane or sevoflurane. PURPOSE To find out if maintenance of anesthesia with propofol leads to less postoperative pain after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane, or sevoflurane.

COMPLETED
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
Description

Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.

COMPLETED
A Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
Description

This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.

COMPLETED
NOTES-Assisted Laparoscopic Cholecystectomy Surgery
Description

Refinements in laparoscopic surgery, coupled with advancements in therapeutic flexible endoscopy, have set the stage for surgery to move to even less invasive techniques to treat conditions in the GI tract and peritoneal cavity. Natural orifice translumenal endoscopic surgery (NOTES) offers a means of reducing and ultimately eliminating the need for abdominal incisions to gain access to the peritoneal cavity. In NOTES, a flexible endoscope and accessory instruments are inserted through a natural body orifice and passed through the wall of an organ to reach the abdominal cavity. By reducing or eliminating the need for abdominal incisions, NOTES may provide a least invasive surgical option that can reduce pain, recovery time, complications, and systemic inflammatory response when compared to a laparoscopic surgical approach. In this study, we propose to use the NOTES technique to eliminate the need for a 1.5-2.5 cm umbilical incision. Hypothesis 1: We hypothesize that a combined endoscopic and laparoscopic approach will be able to eliminate a 1.5 to 2.5 cm infraumbilical incision when performing a laparoscopic cholecystectomy. Hypothesis 2: Closure of the gastrotomy will be facilitated with the Ethicon TAS system.

COMPLETED
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
Description

The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.

COMPLETED
Randomized Trial of ERCP Then Laparoscopic Cholecystectomy vs. Laparoscopic Cholecystectomy Plus Laparoscopic Common Bile Duct Exploration in Patients With Likely Choledocholithiasis
Description

Objective: We compared outcome parameters for good-risk patients with classic signs, symptoms, laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either LC + LCBDE or ERCP/S + LC. Design: Our study was a prospective trial conducted following written informed consent with randomization by the serially-numbered opaque envelope technique. Setting: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco. Patients: We randomized 122 patients (American Society of Anesthesiologists Grade I or II) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before one of both procedures were completed. Interventions: Treatment was pre-operative endoscopic retrograde cholangiopancreatography sphincterotomy (ERCP/S) followed by laparoscopic cholecystectomy (LC), or laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC + LCBDE). Main Outcome Measures: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary endpoints were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.

COMPLETED
Single Incision Laparoscopic Cholecystectomy
Description

The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy. The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.

Conditions
COMPLETED
Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy
Description

This study looks at the differences in inflammatory mediators in gallbladder tissue between males and females and the possibility that these differences contribute to a higher perception of post-operative pain in females following laparoscopic cholecystectomy.

TERMINATED
NOTES-Assisted Laparoscopic Cholecystectomy Surgery
Description

This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.

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

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.

Conditions
COMPLETED
Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy
Description

The study aims to evaluate the short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies.

COMPLETED
Image Fusion in the OR
Description

The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.

COMPLETED
Comparing Effectiveness of IV vs Oral Acetaminophen Given Perioperatively for Lap Choles for Pain Control,
Description

The purpose of the study is to learn whether perioperative IV (intravenous) administration of acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes over the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen, it may result in fewer requests for pain-related intervention such as other oral pain medications.