Clinical Research Directory

Bassini Repair Versus Desarda Technique in Urgent Complicated Inguinal Hernia Repair

Inguinal hernias occur when abdominal contents, such as intestine or fat, protrude through a weakness in the lower abdominal wall. While most hernia repairs are scheduled electively, some hernias present as urgent emergencies due to incarceration (the contents become trapped) or strangulation (the blood supply to the trapped tissue is cut off). In emergency operations, synthetic mesh placement may be avoided due to the increased risk of surgical site infections, tissue swelling, or bowel contamination. In such settings, surgeons rely on tissue-based (mesh-free) repairs. The conventional Bassini repair is a standard non-mesh technique, but it can be associated with higher hernia recurrence rates. The Desarda technique is a physiological, mesh-free repair that uses an undetached strip of the patient's own external oblique aponeurosis (tendinous muscle tissue) to reinforce the weakened inguinal floor without tension. The main objective of this study is to compare the surgical outcomes of conventional Bassini repair alone versus Bassini repair combined with the Desarda technique in adult patients undergoing emergency surgery for urgent, complicated inguinal hernias. This prospective randomized controlled trial is conducted at the Department of General Surgery, Assiut University Hospital. A total of 70 eligible participants presenting with acutely complicated inguinal hernias will be randomly assigned to one of two equal groups: * Group A (Bassini Repair): Patients undergo standard open emergency tissue herniorrhaphy alone. * Group B (Desarda Repair): Patients undergo emergency herniorrhaphy combined with the Desarda aponeurotic reinforcement technique. Participants are monitored during their hospital stay and will attend structured outpatient follow-up visits up to 12 months postoperatively. The primary outcome evaluated is the rate of hernia recurrence. Secondary outcomes include surgical site infections, seroma and hematoma formation, postoperative pain scores (using the Visual Analogue Scale), duration of operative procedure, hospital stay length, and time required to resume normal activities and return to work.

Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair

The goal of this clinical trial is to learn whether slowly dissolving stitches work as well as permanent stitches for repairing a groin (inguinal) hernia in adults using the Shouldice technique, a hernia repair that does not use mesh. Researchers think dissolving stitches may cause less long-term groin discomfort without making the hernia more likely to come back. The main questions it aims to answer are: Is the chance of the hernia coming back within 1 year different with dissolving stitches (PDS) compared with permanent stitches (Prolene)? Do the two types of stitches differ in complications, groin pain, quality of life, or the feeling of something foreign in the groin? Is a larger future study of this question possible? This includes whether enough people join, whether the study plan is followed, and whether participants complete follow-up. Researchers will compare slowly dissolving polydioxanone (PDS) stitches with permanent polypropylene (Prolene) stitches to see if the hernia comes back at similar rates and if patients have less long-term discomfort. Participants will: Have their planned open Shouldice hernia repair. The type of stitch will be chosen at random, like flipping a coin, during surgery. Not be told which stitch they received until 1 year after surgery, or sooner if the hernia comes back or another operation is needed. Complete questionnaires about pain, activity, and quality of life before surgery and about 30 days, 6 months, and 1 year after surgery. See their surgeon for routine visits about 30 days and 1 year after surgery. Receive one research phone call about 6 months after surgery. Answer whether they feel something foreign in their groin and which type of stitch they think they received.

Corona Mortis in Patients Undergoing TEP for Inguinal Hernia

This study aim to describe the presence, type and size of Corona mortis (CMOR) in patients undergoing total extraperitoneal (TEP) inguinal hernia repair procedures. This study also aim to describe the preperitoneal vascular anatomy of inguinal area and provide in vivo knowledge about CMOR.

Desarda Repair for Inguinal Hernia in Adolescent Males

This retrospective single-centre case series evaluates the feasibility and clinical outcomes of selective open Desarda repair for inguinal hernia in adolescent males treated in a paediatric surgical department. The study focuses on recurrence, postoperative complications, reoperation, persistent groin pain, postoperative length of stay, and follow-up after Desarda repair.

A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults

The purpose of this study is to collect data about local versus general anesthesia for inguinal hernia repair in Veterans aged 60 years for planning a larger, multisite randomized clinical trial. Approximately 80 participants will be enrolled and can expect to be on study for 6 months.

Ultrasound-Guided Ilioinguinal-Iliohypogastric Nerve Block Following Spinal Anesthesia Comparing Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Unilateral Inguinal Hernia Repair

This study evaluates and compares the pain-relieving efficacy and safety of adding either dexmedetomidine or nalbuphine to bupivacaine in an ultrasound-guided ilioinguinal-iliohypogastric nerve block for patients undergoing elective unilateral inguinal hernia repair under spinal anesthesia. While spinal anesthesia provides effective surgical anesthesia, postoperative pain often increases as the block recedes. Supplementing spinal anesthesia with an ultrasound-guided peripheral nerve block targeting the ilioinguinal and iliohypogastric nerves provides localized pain relief. Adding adjuvant medications to the local anesthetic may extend the duration of pain control and reduce systemic analgesic requirements. Participants are randomly allocated to one of three groups: * Control Group: Receives bupivacaine with normal saline. * Nalbuphine Group: Receives bupivacaine combined with nalbuphine. * Dexmedetomidine Group: Receives bupivacaine combined with dexmedetomidine. The primary objective is to assess the duration of analgesia by measuring the time from the regression of spinal sensory anesthesia until the first request for rescue pain medication. Secondary objectives include evaluating total 24-hour pain medication consumption, postoperative pain scores, vital signs, sedation scores, patient satisfaction, and side effects.

Safety and Effectiveness of Optomesh 3D for Inguinal Hernia Repair

OPTIMUS is an observational study assessing the safety and effectiveness of Optomesh 3D, a shaped surgical mesh used in planned keyhole surgery for a groin (inguinal) hernia. The mesh is placed without additional stitches, tacks, or glue to hold it in position. The study aims to include at least 300 patients from several hospitals. The main question is how often a hernia returns within 12 months after surgery. Researchers will also assess pain, postoperative complications, discomfort in the groin, and the feeling of having a foreign material in the operated area. Participants will provide written consent for the study. Information about their health and operation will be recorded. Follow-up information will be collected through telephone interviews at 7-10 days, 30 days, 3 months, and 12 months after surgery. The results will be assessed in relation to previously published findings on hernia repair.

Swing-Mesh™ Study (SMS).

This multicenter, prospective observational study aims to assess the safety and efficacy of the Swing-Mesh™ implant (THT BioScience™, distributed by B. Braun™, France) for laparoscopic-endoscopic inguinal hernia repair using TAPP or TEP techniques. Swing-Mesh™ is a lightweight, macroporous, three-dimensional mesh designed to conform anatomically to the myopectineal orifice without requiring fixation. Eligible adult patients undergoing elective repair will receive the implant. The primary endpoint is hernia recurrence within 6 months. Secondary endpoints include postoperative pain, groin discomfort, and early and late complications. The study will provide clinical evidence regarding the non-inferiority of this spatial, fixation-free mesh compared to standard devices in minimally invasive hernia surgery.

Image-Guided Herniorrhaphy Study

This pilot clinical study will evaluate the safety and effectiveness of a new image-guided, needle-based approach for repairing abdominal or groin hernias in adults who are unable or unwilling to undergo traditional open or laparoscopic surgery. The technique uses ultrasound and, when needed, CT imaging to guide a hollow needle preloaded with barbed suture through the skin to close the hernia defect without large incisions or general anesthesia. Each participant will undergo one image-guided procedure and will be followed for eight months to assess complications and changes in hernia-related quality of life. Approximately thirty participants will be enrolled. The study aims to determine whether this minimally invasive approach is safe, feasible, and capable of improving hernia symptoms enough to justify a larger clinical trial

Effect of Acupressure on Postoperative Pain After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair

This randomized, sham-controlled clinical trial aims to evaluate the effect of acupressure on postoperative pain following laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. A total of 90 participants will be randomly assigned to one of three groups: standard postoperative care alone (control group), true acupressure plus standard care, or sham acupressure plus standard care. Acupressure will be applied at postoperative hours 1, 4, and 8 using the bilateral P6 (Neiguan), LI4 (Hegu), ST36 (Zusanli), and SP6 (Sanyinjiao) acupoints. The sham group will receive pressure at non-acupuncture points. The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes include analgesic consumption, postoperative nausea and vomiting, time to mobilization, patient satisfaction, and postoperative complications.

SetUp Study for HugoTM RAS Inguinal Hernia Repair

The goal of this observational cohort study is to evaluate the evolution of the operative time in performing robotic-assisted laparoscopic inguinal hernia repair (rTAPP) during the learning curve of the first 50 patients using the HugoTM Ras (Medtronic) robotic system using the setup guide. This will be compared to the operative time for rTAPP in 50 patients performed by the same surgeon in another hospital. This data was collected in an earlier similar study with the start of the experience using the daVinci Xi (Intuitive Surgical) robotic system.

Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair

Evaluate the early postoperative course of patients undergoing laparoscopic inguinal hernia repair with either a conventional or a robot assisted approach and with or without the injection of the trocar wounds with a local anesthetic.

LESS TEP vs. Three Port TEP for Inguinal Hernia Repair

This study aim to compare efficacy and safety of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/.

Methocarbamol in Ventral and Inguinal HR

The purpose of this study is to gather information on methocarbamol as a pain management treatment for ventral or inguinal hernia repair. Methocarbamol has been part of the pain management treatment for both inpatient and outpatient procedures at Prisma Health. This study will compare the outcomes of patients who receive methocarbamol, those who receive the standard opioid pain management treatment, and those who receive methocarbamol plus the standard opioid pain management treatment. Participants will be randomized into one of the study groups listed below. Primary ventral hernia repair or inguinal hernia repair: Group 1: standard opioid after surgery Group 2: methocarbamol after surgery Open or robotic ventral hernia repair outpatient: Group 1: standard opioid after surgery Group 2: standard opioid plus methocarbamol after surgery Open or robotic ventral hernia repair inpatient: Group 1: standard opioid at discharge Group 2: standard opioid plus methocarbamol at discharge A total of 200 participants will be included in the study. Participation will last for about 30 days after surgery.

Perioperative Rehab for Inguinal Hernia Repair

Despite how common inguinal hernia repair (IHR) surgery is, there is little research on how best to prepare people for this operation. Surgeons' advice to patients about exercise and physical activity are inconsistent and usually based on their clinical opinion. Some surgeons recommend exercise to help prepare for the operation while others say to rest. Research is needed to help know whether exercise is helpful before and after IHR surgery. This study will observe the effects of education and exercise before and immediately after IHR surgery. Half of the participants will be randomized to an education and exercise group and the other half to a non-exercise, care as usual group. Participant outcomes will be measured up to 3 months after their surgery. It is expected that participants in the education and exercise group will have: 1) less pain at follow-up, 2) better hernia-related outcomes, 3) quicker return to activity and work, and 4) improved overall experience surrounding IHR surgery. This project will help in developing clear guidelines for pre- and post-operation to better prepare patients for IHR surgery.

TransREctus Sheath PrePeritoneal Procedure (TREPP) for Inguinal Hernia Repair

Inguinal hernia repair remains one of the most commonly performed surgical procedures worldwide. Tension-free repair with mesh augmentation is the predominant treatment option, either achieved by preperitoneal laparoscopic hernioplasty or Lichtenstein procedure (LP). As the recurrence rate is reduced to less than 5 % after mesh repair, nowadays, long-term morbidity associated with open inguinal hernia repair is mainly related to chronic postoperative inguinal pain (CPIP). Despite many hypotheses about the possible causes for CPIP, there is now consensus that involvement of inguinal nerves plays a major role. The trans rectus sheath extra-peritoneal procedure (TREPP) is a minimally invasive open approach utilizing the rectus sheath to access the preperitoneal space. It has shown promise in providing effective repair with potential advantages in cosmesis, postoperative pain, and recurrence rates. It is a medial approach avoiding the interference with the course of all (three) inguinal nerves through lateral abdominal wall.

Desarda's Technique Versus Lichtenstein's Technique Hernia Repair in Management of Elective Non-Complicated Inguinal Hernia

This study aims to compare Desarda's technique and Lichtenstein's technique of hernia repair in managing elective, non-complicated inguinal hernia.

Evaluation of Desarda Technique in Management of Complicated Inguinal Hernia

This study aims to evaluate the desarda technique in management of complicated inguinal hernia.

Inflammatory Response: General vs Spinal Anesthesia

Objective: This study aimed to compare the effects of general and spinal anesthesia on the inflammatory response by measuring intercellular adhesion molecule-1 (ICAM-1), P-selectin (SELP), and thrombomodulin (TM) levels in patients undergoing inguinal hernia repair. Materials and Methods: A total of 43 patients scheduled for IHR were divided into two groups: general anesthesia (Group G, n=21) and spinal anesthesia (Group S, n=22). Blood samples were collected at the following time points: for Group G-before induction (T0), after intubation (T1), 15 minutes after surgical incision (T2) and 15 minutes after final skin suturing (T3); for Group S-before spinal anesthesia (T0), after spinal anesthesia (T1), 15 minutes after surgical incision (T2) and 15 minutes after final skin suturing (T3). ICAM-1, SELP and TM levels were analyzed.

Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)

A prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the Medtronic Hugo™ RAS system. Subjects will be followed through two years. This study will be conducted using up to ten investigative sites in the United States (US).

The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia

The cutaneous silent period is a non-invasive technique that gives insight into the function of thin A delta fibers and as such can be a complement to conventional electrophysiological methods used to study the peripheral nerves. Clonidine is a selective partial agonist of the alpha-2 receptors which, added intrathecally to levobupivacaine, enhances the effect of a local anesthetic, prolongs sensory and motor block during local anesthesia and extends the length of post-operative analgesia. It is believed that clonidine achieves this effect by activating the postsynaptic alpha-2 receptors in the gelatine substance of the spinal cord and blocking the conduction of A-delta and C fibers. The aim of the study is to examine functional changes of Aδ - fibers during the application of spinal anesthesia by measuring the cutaneous slinet period and compare the effect of intrathecal administration of a combination of local anesthetic and clonidine in the quiet skin period in relation to the application of local anesthetic only.

Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output

This study serves as a pilot study with the intention to to measure intraabdominal pressure, lactic acid, and urine output in obese individuals undergoing laparoscopic inguinal hernia repair. By measuring these values, the investigators aim to look for correlations between metrics and determine an accurate and precise measurement of IAP during laparoscopic hernia surgery using the Accuryn Monitoring System. By obtaining accurate and precise measurements of IAP during surgery the investigators will be to compare measurements to previous IAP data obtained during daily activities and strenuous movements and any associations with inguinal hernia recurrence.

The Significance of the Mesh Thickness in the Operation of Inguinal Hernia

The trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes. Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.

Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)

The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.