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Hernia, Inguinal clinical trials

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NCT ID: NCT02715622 Completed - Inguinal Hernia Clinical Trials

A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients

Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair. The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.

NCT ID: NCT02712827 Completed - Hernia, Inguinal Clinical Trials

Comparison of Different Meshes in Laparoscopic Hernia Repair

Start date: April 2016
Phase: N/A
Study type: Interventional

The placement of mesh is important in hernia surgery as it helps to reduce recurrence, yet the method of fixation of mesh may cause pain after surgery. In laparoscopic hernia repair, surgeon uses different methods to fix the mesh in large hernia defects or bilateral inguinal hernias. Progrip is a special mesh developed by manufacturer that it can be self-gripped to tissue, as a result no fixation is required after placement. There are few data about Progrip in laparoscopic hernia repair. In this randomized controlled trial we would like to compare the use of Progrip with the "conventional" mesh in laparoscopic hernia repair. Surgery is performed in the usual manner; prior to placement of mesh, surgeon will get the randomization result for that particular patient: Progrip and non-Progrip group. No fixation is required for Progrip group, while fixation with fibrin glue is needed for non-Progrip group. Intraoperative data (e.g. mesh deployment time, operative time, etc) will be collected. Patients will be assessed in clinic at 2-week, 3-month, 6-month and 1-year interval after surgery. Additional visits may be arranged if considered necessary. At follow up patient will be seen by surgeon first to review the wound condition and to look for any recurrence; while other post-operative data including total analgesic usage (number of tablets), return to normal activities (days), return to work (days), pain score etc will be assessed and recorded by a trained nurse who is blinded to the treatment that patient received. Any hernia recurrence will be recorded and treated accordingly. Primary aim of this study is to look for any difference of the 2 groups in terms of postoperative pain and quality of life scores.

NCT ID: NCT02696837 Completed - Inguinal Hernia Clinical Trials

Pediatric Inguinal Hernia Repair: Are Muscle Relaxants Necessary? Endotracheal Intubation vs Laryngeal Mask Airway

Start date: March 2016
Phase: N/A
Study type: Interventional

In prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair using PIRS (Percutaneous Internal Ring Suturing) method will be randomly assigned into four groups. Gr 1: Endotracheal intubation and muscle relaxant, Gr 2: Endotracheal Intubation without muscle relaxant, Gr 3: Proseal Laryngeal Mask Airway without muscle relaxant, Gr 4: Proseal Laryngeal Mask Airway with subparalytic does muscle relaxant. Apart from standard monitorization, all patients' intragastric pressures will also be monitored. Patients' age at presentation, gender, time of surgery, time of anesthesia, intragastric pressure, intraabdominal pressure, intraoperative findings and complications will be noted and compared between groups.

NCT ID: NCT02696122 Completed - Quality of Life Clinical Trials

Quality of Recovery After General or Spinal Anesthesia for Inguinal Hernia Repair

Start date: February 2016
Phase: N/A
Study type: Interventional

Different anesthetic techniques have been proposed for carrying out Inguinal hernia repair, including local anesthesia, regional and general. There are no recent data on the application of a validated questionnaire to assess which anesthetic technique, local infiltration under general anesthesia or spinal anesthesia, would provide better quality of recovery in the opinion of the patients undergoing inguinal hernia repair. The aim of the study is to perform a randomized clinical trial comparing the quality of recovery (QoR-40) after local infiltration under general anesthesia via laryngeal mask (LMA) or spinal anesthesia for unilateral inguinal hernia repair. METHODS - Seventy patients aged 18 to 65 years old, who were scheduled to undergo unilateral inguinal hernia repair at Santa Lucinda Hospital will be enrolled in the study. The anesthesia will be performed according to the following sequence: L Group - intravenous (I.V.) propofol and alfentanyl, followed by LMA positioning. The anesthesia will be maintained by propofol. For local anesthesia, approximately 50 ml of 0.5% ropivacaine will be infiltrated along the line of incision in the subcutaneous plane, followed by peripheral nerve block technique (e.g., ilioinguinal-hypogastric nerve block) and local wound infiltration at the fascial level. S Group - spinal puncture followed by intrathecal 15 mg of 0.5% hyperbaric bupivacaine injection and sedation with propofol by continuous infusion. Pain will be assessed every 15 minutes at Post-anesthesia Care Unit (PACU) using a 0-10 numeric pain rating scale and I.V. morphine will be administered to maintain the pain score below 4. The QoR-40 will be administered by a blind investigator 24 hours after surgery.

NCT ID: NCT02684448 Completed - Hernia, Inguinal Clinical Trials

Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair

Start date: January 2016
Phase: N/A
Study type: Observational

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.

NCT ID: NCT02632097 Completed - Inguinal Hernia Clinical Trials

Histoacrylâ„¢ vs. Suture for Mesh Fixation in Lichtenstein Hernioplasty: A Randomized Prospective Double-Blinded Study

Histoacryl1
Start date: March 2013
Phase: N/A
Study type: Interventional

This is a prospective, randomized double-blinded study to find out if mesh fixation with n-butyl-2-cyanoacrylate (NBCA) are more painless than conventional mesh fixation with sutures in inguinal hernia operation (Lichtenstein procedure) in day-case surgery. Our hypothesis is that glue fixation is safe, simple and fast method compared to conventional Lichtenstein technique.

NCT ID: NCT02616406 Completed - Hernia, Inguinal Clinical Trials

Objective Measure of Recovery After Outpatient Surgery

Start date: November 2015
Phase:
Study type: Observational

This is a study using wearable monitoring devices, patient activity and sleep patterns to monitor pre and post operative following outpatient inguinal hernia surgery to determine when these parameters return to baseline.

NCT ID: NCT02561910 Completed - Clinical trials for Unilateral Inguinal Hernia With Gangrene and Obstruction

Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results

Start date: January 2000
Phase: N/A
Study type: Observational

The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one year period a total of 1208 inguinal hernias in 952 patients were consecutively operated using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine. Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the standard procedure in inguinal hernia repair in future.

NCT ID: NCT02559102 Completed - Clinical trials for Neurodevelopmental Disorder

Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants

DEGA
Start date: July 2015
Phase: Phase 3
Study type: Interventional

This is a prospective randomized controlled trial comparing dexmedetomidine sedation with caudal anaesthesia, and general sevoflurane anaesthesia with caudal anaesthesia for inguinal herniotomies in neonates and infants below 3 months of age. The investigators will compare the efficacy and adverse events associated with each of these techniques and neurodevelopmental outcomes of the infants in each group at 6 months and 2 years of age.

NCT ID: NCT02545270 Completed - Hernia, Inguinal Clinical Trials

Validation of a Subjective Rating Scale for Assessment of the Surgical Workspace in Laparoscopy

Start date: March 2016
Phase: N/A
Study type: Interventional

It is of great importance to obtain optimal surgical conditions for the surgeon in order to increase patient safety. The effect of different interventions on surgical conditions has been assessed by various surgeon-assessed rating scales. A 5-point surgical rating scale has previously been tested in a proof-of-concept trial - but not validated - during radical retropubic prostatectomy by asking different surgeons to evaluate the surgical workspace using video sequences. In an ongoing study (The Hernia Study, Trial registration NCT02247466) performed by investigators group, investigators are using a 5-point scale to rate the surgical workspace during laparoscopic ventral herniotomy with or without neuromuscular blockade. This scale is based on previously used scales by already published studies and has a description connected to each point. To the authors' knowledge the scale has never been validated in a laparoscopic setting, where the intra-abdominal pressure during pneumoperitoneum can have a great influence on visualization. In fact, to investigators knowledge, no validated surgeon-assessed rating scale regarding the surgical workspace during laparoscopic surgery does exists. Purpose: Primary aim: To validate a 5-point rating scale by investigating the inter-rater agreement of evaluations of the surgical workspace at different intra-abdominal pressures. Using intra-abdominal video recordings. Secondary aims: To validate a 10-point rating scale by investigating the inter-rater agreement of evaluations of the surgical workspace at different intra-abdominal pressures. To test the agreement between the two rating scales. To assess which of the two rating scales has the highest inter-rater agreement To assess the intra-rater agreement of both rating scales. Hypothesis: Investigators hypothesize that the 5-point rating scale has an intra-class correlation coefficient (ICC) > 0.6., validated by video-sequences obtained during laparoscopic surgery.