Treatment Trials

19 Clinical Trials for Various Conditions

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COMPLETED
Virtual Visits (Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience)
Description

The purpose of this study is to implement and evaluate postoperative virtual care visits for patients who undergo a laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic cholecystectomy. The investigators aim to better understand whether postoperative virtual care visits will not result in a greater composite measure of the occurrence of hospital encounters within Atrium Health (AH) for the 30 days following surgery than standard in-person clinic care. The investigators also aim to better understand whether postoperative virtual care visits provide time and cost savings, and provide equal or improved patient satisfaction and convenience.

COMPLETED
Transrectal NOTES Appendectomy - Feasibility Study
Description

Natural orifice translumenal endoscopic surgery (NOTES) has revolutionized the concept of minimally invasive surgery. NOTES is currently performed through transgastric or transvaginal approaches. The transvaginal approach is technically easier, but is only available to women. A transrectal approach has been proposed as a potential alternative to transvaginal NOTES for men. Fortunately, the technology to facilitate transrectal access and closure for NOTES has been in use for over twenty years, in the form of transanal endoscopic microsurgery (TEM) platforms. We hypothesize that transrectal NOTES appendectomy is feasible in humans using a flexible endoscope and a TEM platform to assist with transrectal access and closure. After a pre-clinical study involving 5 cadavers, we will perform a clinical study of 10 transrectal NOTES appendectomies in patients already scheduled to undergo laparoscopic total proctocolectomy or total abdominal colectomy. The tissues involved in the NOTES procedure will be removed as part of the patient's originally scheduled operation, reducing the risk of morbidity as a result of an inadequate transrectal closure or appendiceal stump leak. We will measure operative times, complication rates, peritoneal contamination, and assess the integrity of the rectotomy closures. We hope to show that transrectal NOTES appendectomy is clinically feasible in humans using a TEM platform.

WITHDRAWN
Identifiable Factors That May Lead to Postoperative Nausea and Vomiting After Simple Laparoscopic Appendectomy
Description

This is a retrospective chart review meant to identify any factors that are correlated with and may possibly lead to postoperative nausea and vomiting in order to predict need for longer hospital stays and potentially decrease postoperative nausea and vomiting.

COMPLETED
Comparative Study of Polymetric Clips (Hem-o-Lok) Versus Historical Endoscopic Staplers for Laparoscopic Appendectomy
Description

The purpose of this study is to compare the clinical outcomes and the operative costs of appendectomy performed with the Hem-O-Lok polymetric clips compared to endoscopic staplers. Prospective data will be collected before, during, and after surgery on patients undergoing a laparoscopic appendectomy that have the Hem-o-Lok ® stapler used to close the stump after the appendix is removed. Use of the Hem-o-Lok ® stapler is standard for appendectomy patients at Duke Regional Hospital. Retrospective data will be collected from patients who had an appendectomy prior to 1/2012 using a different clip as part of their surgery, or an open appendectomy to compare outcomes.

Conditions
COMPLETED
Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Peripheral Nerve Block Versus Local Anesthetic
Description

After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in the postoperative period. As a routine part of the procedure, surgeons inject local anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most children will still require additional pain medications after surgery. The purpose of the study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal nerve) will give better pain relief, decreasing pain medication requirements and increasing comfort during the postoperative period.

COMPLETED
Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy
Description

Oxygen has inherent bactericidal properties. The investigators are testing to see if they can reduce the incidence of postoperative abscesses following laparoscopic appendectomy by insufflating with oxygen at the end of the case.

TERMINATED
Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis
Description

Recent advances in laparoscopic instrumentation have made it possible to perform intra-abdominal operations entirely through a small incision that can be hidden within the umbilicus. The goal is to perform surgery with fewer incisions and no visible scars. Other potential benefits are faster recovery, less pain, and fewer wound complications. The term SILS (Single Incision Laparoscopic Surgery) is being used to describe such techniques, and many have touted SILS as a major breakthrough in minimally-invasive surgery, moving the field closer to surgery that is bloodless, incisionless, and painless. Despite the hype, prospective comparisons of SILS versus conventional laparoscopy are lacking. Results of SILS procedures have generally been limited to case reports and small case series that lack controls. The investigators propose to conduct a prospective, randomized, single-center trial of SILS appendectomy versus conventional laparoscopic appendectomy to treat acute appendicitis. Primary end-points are operative time, complication rate, postoperative pain, recovery time, and long-term cosmetic outcome. The investigators hypothesize SILS appendectomy is equivalent to laparoscopic appendectomy with respect to operative time, complication rate, postoperative pain, and recovery time while providing a better cosmetic outcome.

Conditions
COMPLETED
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy
Description

This is a prospective trial of single incision versus standard 3-port laparoscopic appendectomy. The hypothesis is that there may a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars.

Conditions
COMPLETED
A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine
Description

The purpose of this research is to determine if spraying a local anesthetic to the cecum after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed after surgery and reduces the time to discharge from the hospital.

WITHDRAWN
Pain Control Without Opioids
Description

Adequate outpatient pain control after uncomplicated laparoscopic appendectomy or cholecystectomy can be achieved with minimal breakthrough drugs when used in combination with around the clock non-opioid medications.

COMPLETED
Postoperative Activity Restrictions in Children
Description

This study will investigate the need for and length of postoperative activity restrictions in children following a laparoscopic appendectomy or inguinal hernia repair. Currently, no consensus exists and restrictions are based on doctors' experience and preference. Children and their parents/guardians will decide if they wish to participate in this study. Those who wish to participate and who are eligible to participate will decide which postoperative activity restrictions they would like the child to follow. The child will follow either 1) doctor-directed restrictions or 2) self-directed restrictions.A parent or guardian will complete a survey 1-3 months after the procedure, to assess patient and family satisfaction and patient outcome.

TERMINATED
Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination
Description

Background: Millions of pediatric patients undergo laparoscopic surgeries every year and many of them suffer significant pain and anxiety. Patient's anxiety correlates with the severity of pain and effective postoperative analgesia is necessary for optimal recovery. Single injections ultrasound guided rectus sheath blocks provide satisfactory postoperative analgesia after pediatric laparoscopic appendectomy, however they are short lived. Searching for a blocking agent that last long enough to outlast pain and has minimal side effects is a difficult task. Using a combination of drugs yielded mixed results. Few pediatric studies showed at best a weak trend in favor of clonidine prolonging analgesia after some blocks, but anxiolytic properties of clonidine were not investigated. This study will compare rectus sheath ropivacaine blocks with ropivacaine and clonidine blocks. Methods: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be double blinded and randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location, and Ropivacaine Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg). Post-operative analgesia will be provided with ketorolac and acetaminophen around the clock, and morphine, or/and oxycodone as needed. The primary aim is to determine if ropivacaine combined with clonidine prolongs duration of paresthesia. The secondary aims are to determine if the use of clonidine decreases anxiety level, prolongs duration of analgesia, and decreases pain severity at umbilicus laparoscopic site, reduces the need for analgesics, improves satisfaction with pain control, and is associated with complications such as oversedation, hypotension, and bradycardia. Conclusions: Every hour of excellent analgesia count and a prolongation of block duration by at least 50% is clinical relevant. The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine offer improved pain management compared to ropivacaine alone.

COMPLETED
TICAP - Titanium Clips for Appendiceal Stump Closure
Description

Laparoscopic appendectomy is progressively accepted as the treatment of choice for acute appendicitis. Although the surgical technique of laparoscopic appendectomy has been well established, some controversy exists regarding the closure of the appendiceal stump. The available methods for stump closure are currently: pre-knotted loops (Roeder Loops or Endoloop, linear stapler and polymeric clips. A new device is a the DS Titanium Ligation Clip. The design of the DS-Clip is characterized by two parallel shanks. The aim of this study is to collect data of a large number of patients treated with the product in real-life clinical routine.

Conditions
TERMINATED
Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies
Description

This study is a prospective, double-blinded, randomized comparison of 2 patient cohorts. One group of patients will receive a transversus abdominis plane (TAP) block. The second group will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery for a laparoscopic appendectomy. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block or local anesthetic infiltration by the surgeon for analgesia to compare the most appropriate delivery of effective analgesia. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of multimodal techniques in infants and children.

Conditions
COMPLETED
Irrigation Versus No Irrigation for Perforated Appendicitis
Description

The purpose is to quantify the effect of irrigation during laparoscopic appendectomy for perforated appendicitis.

COMPLETED
Laparoscopic Versus Open Appendectomy? Let the Patient Decide
Description

This protocol examines choice where it pertains to choosing between two standard methods for appendectomy, laparoscopic or open procedures, and the affect that "cost" of the appendectomy has upon choice. Children admitted with a diagnosis of uncomplicated appendicitis will be consented to participate in a study in which the patient can choose between laparoscopic or open appendectomy procedures. Those that agree to review a consent form will be randomly placed into one of two groups. The two groups consist of one in which the consent form includes "cost information for each operative procedure" in the comparison between the procedures, and the other group receives a consent form that does not include "cost information for each operative procedure". Both groups also view a short, group specific, computerized presentation that describes each procedure. The hypothesis is that those patients given a choice between two similar surgical procedures and are provided with "cost information" will more often choose the less expensive surgical procedure than those that do not have information related to the cost of the surgical procedures.

Conditions
COMPLETED
Comparative Study of Laparoscopic Versus Open Appendectomy in Children
Description

The study intends to compare the results of two surgical methods to remove the appendix in children with appendicitis. Specifically, up to 500 children over 3 years will be placed in two groups where the only difference in treatment is open or laparoscopic (scope) operation. Each group will be tracked for their baseline characteristics, events during operation and recovery, pain medication requirements, duration of hospital stay, and patient/family satisfaction. The investigators hypothesize that their will be no difference in the parameters measured between the techniques of appendix removal.

Conditions
RECRUITING
Retrospective Acute Care Appendectomy Study
Description

The purpose of this retrospective study is to compare perioperative data for subjects who have undergone an emergent or urgent robotic-assisted or laparoscopic appendectomy for acute appendicitis.

RECRUITING
Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy
Description

This study is designed as a randomized controlled trial with patients assigned to neuromuscular reversal with either sugammadex or neostigmine/glycopyrrolate reversal. The study will not be blinded to the anesthesiologist to allow for appropriate decision-making on timing and dosage of reversal. This is a single-center study.