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Hernia, Inguinal clinical trials

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NCT ID: NCT00788554 Completed - Inguinal Hernia Clinical Trials

LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

LEVEL
Start date: August 2000
Phase: Phase 3
Study type: Interventional

The aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life, postoperative recovery and return to daily activities, complications and recurrences

NCT ID: NCT00756600 Completed - Inguinal Hernia Clinical Trials

A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants

GAS
Start date: October 23, 2006
Phase: Phase 4
Study type: Interventional

The primary purpose of the GAS study is to determine whether different types of anesthesia (Regional versus General) given to 720 infants undergoing inguinal hernia repair results in equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of apnea in the post-operative period after both regional and general anesthesia for inguinal hernia repair in infants. This study is important as it will provide the greatest evidence for safety or toxicity of general anesthesia for human infants.

NCT ID: NCT00754897 Completed - Inguinal Hernia Clinical Trials

Feasibility Study for PANDAS

Start date: November 2008
Phase: N/A
Study type: Observational

We have been asked to participate in the Pediatric Anesthesia NeuroDevelopmental Assessment Study (PANDAS), which is a study to compare neurocognitive functions in sibling pairs: one of whom had exposure to anesthesia during inguinal hernia surgery before three years of age (exposed) and the other who was not exposed to anesthesia or surgery in the first three years of life (unexposed). A consortium of approximately 6 hospitals is doing this feasibility study to determine if there is an adequate number of subjects for each of the two age groups before the formal study begins.

NCT ID: NCT00749268 Completed - Hernia, Inguinal Clinical Trials

AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

Start date: October 2008
Phase: Phase 4
Study type: Interventional

The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.

NCT ID: NCT00735124 Terminated - Pain Clinical Trials

Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy

Start date: November 6, 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The study will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements.

NCT ID: NCT00716768 Completed - Inguinal Hernia Clinical Trials

Trial of Laparoscopic Compared to Open Inguinal Hernia Repair in Children Younger Than 3 Years

Start date: October 2007
Phase: N/A
Study type: Interventional

Laparoscopic techniques have been applied widely to the management of various common pediatric surgical diseases. Current evidence lacks sufficient quality to justify the widespread adoption of the laparoscopic approach to the repair of inguinal hernias within children. It is important to critically evaluate the efficiency and the potential risks of these new techniques before they can supplant open techniques as the treatment modality of choice. Numerous large case series of laparoscopic inguinal hernia repair have been reported with average length of stay, complication rates, recurrence rates and pain management scores that mirror those of open inguinal hernia repair. Only one randomized controlled trial has been performed to compare the open versus laparoscopic technique which has not provided answers regarding the potential benefits on young infants. Benefits of an open approach in children includes a shorter operative time, while the laparoscopic procedure is associated with less pain and a better cosmetic result. This study will compare open versus laparoscopic repairs of inguinal hernias. The primary outcome variable will be total dose of acetaminophen administered postoperatively for pain management. Secondary outcome variables include 1) Incidence of intraoperative complications such as compromise of testicular vessels, perforation of abdominal viscera; 2) Short-term outcomes such as operative time, rate of conversion from open to laparoscopic procedure, requirement for reoperation within 30 days, wound infection, acute hydroceles and post-operative length of stay; 3) Long-term outcomes such as recurrent inguinal hernia, testicular atrophy and; 4) Cost of hospitalization will be compared between the open and laparoscopic groups. Comparisons will be made in two groups of patients- patients with 1) unilateral hernias and 2) bilateral hernias and will last for 2 years. 102 patients in the unilateral arm and 50 patients in the bilateral arm will be randomized to each treatment group and each subject will be followed for up to 12 months following the surgical intervention. Two study evaluations by telephone (in addition to a single outpatient clinic visit already required as part of standard post-operative care) will be required of each research subject and his/her parent/guardian. The telephone evaluations will occur at 3 and 12 months following surgery. The standard post-operative clinic visit is scheduled at 2 weeks following surgery.

NCT ID: NCT00687375 Recruiting - Clinical trials for Laparoscopic Inguinal Hernia Repair

Laparoscopic Inguinal Hernia Repair- Transabdominal Preperitoneal (TAPP) Versus Totally Extra Peritoneal (TEP)

Start date: April 2007
Phase: N/A
Study type: Interventional

Laparoscopic inguinal hernia repair (LIHR) has got comparable results in comparison to open hernia repair (OHR). Many studies have shown that LIHR gives similar results in terms of recurrence as compared with OHR but with the added advantage of less chances of post operative, pain, wound infection and early return to activity. LIHR was started using the transabdominal preperitoneal (TAPP) approach. Another technique of LIHR that has evolved is totally extra peritoneal (TEP) repair. There is only one study of 52 patients comparing TAPP with TEP repair and thus there is insufficient information as to which of the 2 techniques is better. Therefore, we have designed the present study to compare the transabdominal preperitoneal (TAPP) technique with totally extra peritoneal (TEP) technique of laparoscopic inguinal hernia repair. The advantages of TEP may include - no breach of peritoneum so less risk of bowel injury and post-operative adhesions. We will be using a modified technique of TEP repair where we will not use tacker to fix the mesh to reduce the cost of the procedure. On the other hand, TAPP is easy to perform and probably better for irreducible hernia. There is no such comparative study reported in the literature. We have been performing both TAPP and TEP procedures for hernia repair regularly in the department. RESEARCH HYPOTHESIS: TEP repair of inguinal hernia is better than TAPP repair in terms of reduced cost and avoidance of peritoneal incision. OBJECTIVE: To compare the Transabdominal preperitoneal (TAPP) vs. Totally extra peritoneal (TEP) techniques of laparoscopic inguinal hernia repair.

NCT ID: NCT00683098 Completed - Hernia Clinical Trials

Long-term Results After Endoscopic Total Extraperitoneal Repair of Recurrent Inguinal Hernia

Start date: June 2008
Phase: N/A
Study type: Observational

Evaluation of long-term results for chronic pain and impairment of daily activities after endoscopic total extraperitoneal repair of recurrent inguinal hernia with inguinal pain questionnaire (IPQ).

NCT ID: NCT00681291 Completed - Hernia, Inguinal Clinical Trials

Strattice in Repair of Inguinal Hernias

RING
Start date: April 2008
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.

NCT ID: NCT00659542 Completed - Inguinal Hernia Clinical Trials

Glubran Mesh Fixation in Lichtenstein Hernioplasty

Cyanoacr
Start date: October 2007
Phase: Phase 2
Study type: Interventional

The purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty.