82 Clinical Trials for Various Conditions
The investigators hypothesize that not prescribing opioids after uncomplicated, outpatient IHR will be non-inferior to prescribing opioids (5 tablets of Oxycodone, 5mg; or surgeon preference for intolerance) with respect to requests for opioid refills. Additionally, the investigators believe there will be no significant difference in postoperative readmission for pain quality of life at 30 days in either group.
This research is intended to be a pilot study to identify differences in outcomes for varied lifting and physical activity precautions following surgical repair of single-sided inguinal hernias. The researchers hypothesize that when given the autonomy to return to activity at the patient's discretion, convalescence will decrease in comparison to a control group given specific precautions to refrain from lifting and strenuous activity. Specific aims include differences in convalescence and surgical outcomes for each group, i.e. rates of complications, hernia recurrence, physical activity assessments pre and postop, and quality of life outcomes.
The aim of this double-blind clinical trial is to examine outcomes and pain control after surgery in patients who underwent laparoscopic inguinal hernia repair (IHR) with the use of perioperative transabdominal plane (TAP) block. Research Question: Does transabdominal plane block improve pain when undergoing inguinal hernia repair? The endpoints include whether preoperative TAP blocks improve pain score (primary end point) and decrease opioid use (secondary endpoint) after an inguinal hernia repair. Other end points- complications after surgery.
This study is evaluating the management of chronic post-operative inguinal hernia pain and the impact of hernia mesh removal after previous minimally invasive inguinal hernia repairs. The study aims are to evaluate the change in chronic (\>6 months), nociceptive, postoperative inguinal pain after mesh removal compared to no mesh removal in patients who have previously undergone minimally invasive inguinal hernia repair with pre-peritoneal mesh.
Retrospective review of hernia surgery patients at HHMcGuire VAMC focusing on repair type and postoperative complications.
Inguinal hernias are a common surgical problem. Best management of occult inguinal hernias, defined as hernias unable to be felt on physical exam, is unknown. From prior studies we know that most inguinal hernias will eventually become symptomatic and require surgery (70%). However, doing a repair on a very small, occult hernia may open the patient up to surgical complications, like chronic pain, earlier than necessary. This will be a multi-center randomized controlled trial of surgical repair versus expectant management of occult inguinal hernias. Patients undergoing laparoscopic unilateral inguinal hernia repair will be included. At the time of surgery, the surgeon will determine if there is an occult hernia contralateral side. If present, patients will be randomized to repair of the occult side or expectant management of the occult side. After 1 year post-operative data has been assessed, a decision tool will be created and administered to patients to aid in their decision making about treatments for their hernia.
This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.
Inguinal hernia repair-the most common general surgery operation in the U.S.-provides a unique opportunity to improve outcomes for older patients by changing surgical practice. Nearly 80% of inguinal hernia operations are performed under general anesthesia versus 15-20% using local anesthesia, despite the absence of evidence for superiority. The choice of anesthesia has particular implications for older adults because they face substantial short- and long-term risk of cognitive and physical decline after exposure to general anesthesia. Consequently, the American College of Surgeons and the American Geriatrics Society have identified a critical need in surgery: determining which operations have better outcomes when performed under local rather than general anesthesia. Currently, the evidence for choosing an anesthesia technique for inguinal hernia repair in older adults is inconclusive. Several small randomized trials and cohort studies have suggested that using local anesthesia for hernia repair reduces morbidity by one-third, unplanned readmissions by 20%, and operative time and costs by 15% while other studies showed no significant differences. However, there are significant flaws in these studies that severely limit their applicability to older adults: (1) They mainly focused on younger patients with limited comorbidity burden, largely ignoring individuals aged 65 years and older, (2) They did not adequately examine the effects of general anesthesia on cognitive function and quality of life for older adults and their caregivers, (3) They did not consult with stakeholders to identify outcomes relevant to those groups. The current study aims to address these limitations to determine the ideal anesthesia modality for inguinal hernia repair.
To investigate the effect of tamsulosin on the development of post-operative urinary retention (PUR) after elective laparoscopic inguinal hernia repair (LIHR). This will be accomplished by administering a pre-operative dose of tamsulosin. The primary outcome is the rate of urinary retention necessitating straight catheterization or insertion of foley catheter prior to discharge.
The primary objective of this study is to evaluate the progression of surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair throughout their learning curve.
This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.
This will be a randomized controlled study which will compare the rate of post-operative urinary retention after laparoscopic inguinal hernia repair between patients who receive an intra-operative urinary catheter and those who do not. The primary aim of the study is to determine if the use of intra-operative urinary catheter reduces the incidence of post-operative urinary retention after laparoscopic inguinal hernia repair. Specific patient inclusion criteria include all patients aged 18 years or older presenting for an elective unilateral or bilateral inguinal hernia repair, who are able to tolerate general anesthesia and are considered eligible to have a hernia repair through a laparoscopic approach.
The purpose of this study is to determine if the surgical technique for creation of extraperitoneal space during laparoscopic TEP inguinal hernia repair (telescopic dissection or balloon dissection) has an impact on operative times, early postoperative pain scores, surgical complications and rate of hernia recurrence following laparoscopic TEP inguinal hernia repair.
A multicenter, single-dose study in children 12 to \<17 years of age, 6 to \<12 years of age, and 2 to \<6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in this study will start with the oldest age group (12 to \<17 years) and will continue in a stepwise fashion until appropriate doses are established for all 3 pediatric age groups (12 to \<17 years, 6 to \<12 years, 2 to \<6 years).
Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia repair makes any difference in short-term pain or return to normal activities following the operation. Other studies have shown no significant difference in hernia recurrence rate when metal tacks are not used to hold the mesh in place.
Randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia repair.
Inguinal hernia repair is one of the most commonly performed general surgery operations. However, to date, the ideal surgical approach for inguinal hernia surgery. The investigators therefore, propose a randomized controlled trial comparing laparoscopic inguinal hernia surgery repair to robotic inguinal hernia repair surgery. The investigators hypothesize that the robotic approach to inguinal hernia repair will result in improved post-operative outcomes compared to traditional laparoscopic inguinal hernia repairs. Specific Aim #1: To determine if the robotic approach will result in a significant reduction in postoperative pain and earlier return to full function when compared to a laparoscopic inguinal hernia repair. Specific Aim #2: To perform a cost analysis to determine the financial implications of performing a robotic versus a laparoscopic inguinal hernia repair. Specific Aim #3: To determine the effect of surgeon reported ergonomics when performing laparoscopic versus robotic inguinal hernia repairs. Specific Aim #4: Evaluate the long term hernia recurrence rates associated with laparoscopic versus robotic inguinal hernia repairs.
This study is designed to evaluate pain control of continuous transversus abdominis plane (TAP) blocks placed for open inguinal hernia repair. The investigators hypothesize that there will be improved pain control when compared with sham blocks.
This multi-center, retrospective data collection study will evaluate the feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone robotic-assisted inguinal hernia repair, as well as provide information about the learning curve associated with robotic-assisted (da Vinci®) inguinal hernia repair. In addition, this retrospective data collection study will evaluate the perioperative outcomes of robotic-assisted (da Vinci®) inguinal hernia repair and compare perioperative outcomes with those associated with open hernia repair by the same participating surgeon.
The purpose of this study is to determine whether aspirin taken in the perioperative period will increase the blood loss associated with open inguinal hernia repairs. A secondary purpose of this study is to determine if the aspirin administered in the perioperative period increases the risk of complications associated with open inguinal hernia repairs.
To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.
The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals. The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.
Purpose: To determine if observation (watchful waiting is a safe alternative to routine repair of asymptomatic inguinal hernias in adult males. Scope: Traditionally surgeons are taught that all inguinal hernias should be repaired at diagnosis to prevent the life threatening complications of bowel obstruction or incarceration with strangulation and that operation becomes more difficult the longer a hernia is left un-repaired.
The purpose of this research study is to measure the clinical effectiveness of two different polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of hospital stay, perioperative complications, recurrence rate, pain score, comfort level and postoperative quality of life. A secondary goal of the study is to evaluate the ease of use and time it takes surgical residents to place the mesh and perform the surgery using these two different meshes.
The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia.
This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.
The use of synthetic mesh plugs for open inguinal hernia repair has seen dramatic variability in the number and composition of meshes currently on the world market. The use of biomaterials (PLLA, PGA) in hernia mesh is a relatively new and innovative method. These selected polymers have the ability to degrade while implanted, allowing for sufficient natural tissue healing and scarring. This usage presumably favors a decrease in foreignness, inflammatory reaction, recurrence, and incidence of chronic groin pain. Prior studies with similar plug meshes in the same indication have yielded favorable results which require this mesh to be investigated in its specific application. Primary Objective Evaluate the incidence of peri-operative and post-operative complications after the application of the Parietex plug and patch hernia system in open inguinal hernia repair. We will assess the efficacy of this mesh by examination and the application of a pain scale at the following intervals: 1 month, 3 months, and 1 year, respectively. Assessment is intended to evaluate: * Patient report of pain via their Pain score * Wound complication * Incidence of chronic groin pain * Recurrence rate * Other complications Secondary Objectives Record the description and assessment of the Parietex plug and patch hernia system: * surgical technique * description of dissection and mesh placement * method of fixation * operative times, anesthesia choice * length of hospital stay * mesh handling characteristics * return to daily activities * overall patient satisfaction
Pain relief after open inguinal hernia repair could be improved by administration of TAP block or ilioinguinal/iliohypogastric nerve block. It is unclear which one works better. The investigators hypothesize that doing TAP block closer to the middle of the abdomen would result in improved pain relief due to simultaneous block of ilioinguinal/iliohypogastric nerves.
Increasing experience has identified post-herniorraphy chronic pain as an under-recognized and important complication. Nerve entrapment and injury are recognized as causes of such pain. Operative treatment for selected patients with this condition includes surgical exploration of the affected groin, identification and removal of involved nerves, and removal of meshoma. This procedure has been highly effective in treatment of chronic pain. This study will attempt to subjectively and objectively evaluate the patient's chronic groin pain using quantitative sensory testing (QST) and validated pain scales and questionnaires. Quantitative sensory testing is a method used to assess damage to the small and large nerve fibers. It is used to diagnose and assess the severity of nerve damage, and can also help to determine if a neuropathy is responding to treatment. QST uses a computer testing system to measure how nerves react to vibration and changes in temperature. The procedure is non-invasive and the patient will feel minimal to no discomfort during testing. The hypothesis is that any decrease in subjective pain scores would be accompanied by improved QST results.
Abstract: Minimally invasive techniques are now ubiquitous in the management of surgical disease. Competence in laparoscopy requires specialized training and practice. With the decrease of resident work hours, training programs need to explore and adopt efficient strategies to teach and evaluate laparoscopic skills. For economic, ethical, and legal considerations, the operating room may no longer be the ideal environment for teaching these basic technical skills. There appears to be a role for simulation in response to this need. The transfer of laparoscopic skills learned in a simulated environment to the operating room has showed mixed results. Overall, it seems that surgical skills training outside the operating room is beneficial, but the best method(s) of designing, implementing and evaluating such skills curriculums have yet to be identified. The laparoscopic totally extraperitoneal (TEP) inguinal hernia repair is an example of a procedure that is associated with a steep learning curve and requires mastery of basic laparoscopic skills. In addition, an increased recurrence and complication rates in the early learning curve of this procedure, underscores the importance of adequate training. The current practice of teaching the TEP repair in the operating room under an apprenticeship-based model is associated with increased operative time and costs. We propose that the training of surgical trainees outside the operating room with a structured, mastery oriented simulation-based curriculum will help reduce the learning curve of the TEP repair, improve operative performance, and decrease operative time and costs.