Hernia Clinical Trial
Official title:
Abdominal Wall Closure After TRAM / DIEP Flap - Comparison of TIGR Mesh vs Polypropylene Mesh.
Hypothesis: TIGR mesh as a reconstruction material is a more effective mesh for the repair of the abdominal wall post lipectomy, transverse rectus abdominis myocutaneous (TRAM) / deep inferior epigastric perforator (DIEP) flap.
In this study we will be conducting a randomized trial to study the efficacy of TIGR as a
preferred reconstruction mesh for the repair of the abdominal wall post lipectomy, TRAM /
DIEP flap.
Aims -
1. Investigating the efficacy of TIGR as a preferred reconstruction mesh for the repair of
the abdominal wall post lipectomy, TRAM / DIEP flap. Efficacy of TIGR will allow us to
determine the stability of the material in the abdominal wall reconstruction.
2. Study the absorption characteristics of TIGR implant as compared with a non absorbable
polypropylene mesh. Absorption characteristics can be determined by the amount of
tissue ingrowth, adhesion formation and shrinkage profiles of the implant and it can be
detect using ultrasound.
3. To determine whether any reactions to the implant will occur. These reaction if any
will manifest as inflammation reactions which may be evident on clinical followup and
can be detect by ultrasound.
Patients to be recruited :
80 randomized equally into the 2 groups Age range: 21 - 80 All patients undergoing
lipectomy, TRAM / DIEP flap reconstruction will be recruited into the study.
Trial Duration: July 2010 - July 2015
Follow up:
Postoperative 1 week, 1 month, 3 months, 6 months, and 12 months Ultrasound will be done to
determine the amount of tissue ingrowth, adhesion formation and shrinkage profiles of the
implant in all these follow up appointments. Complications if any can also be detected by
the Ultrasound.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01629485 -
Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair
|
N/A | |
| Terminated |
NCT01305486 -
A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
|
N/A | |
| Completed |
NCT01205399 -
A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
|
N/A | |
| Completed |
NCT00905320 -
Hernia Repair With or Without Sutures
|
N/A | |
| Completed |
NCT01141335 -
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
|
Phase 4 | |
| Completed |
NCT00535990 -
Minimally Invasive Surgery (MIS) Database for the Purpose of Research
|
||
| Completed |
NCT00617357 -
Repair of Infected or Contaminated Hernias
|
N/A | |
| Withdrawn |
NCT00138957 -
Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh
|
N/A | |
| Completed |
NCT06034652 -
T-GENVIH-003 LTFU (Long Term Follow Up) Study
|
||
| Completed |
NCT06389331 -
Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia
|
||
| Completed |
NCT04119466 -
Stabilizing Training in Degenerative Disc Disease
|
N/A | |
| Completed |
NCT00622583 -
International Hernia Mesh Registry
|
||
| Completed |
NCT04137172 -
Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.
|
N/A | |
| Completed |
NCT01132209 -
Suture Techniques to Reduce the Incidence of The inCisional Hernia
|
N/A | |
| Completed |
NCT00032448 -
Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients?
|
Phase 3 | |
| Not yet recruiting |
NCT05061589 -
Incidence and Risk Factors of Parastomal Hernia in Patients With Permanent Colostomy in China
|
||
| Active, not recruiting |
NCT02439060 -
PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)
|
N/A | |
| Completed |
NCT01727388 -
Informativeness to Digital Rectal Examination
|
Phase 3 | |
| Completed |
NCT02238964 -
Reinforcement of Closure of Stoma Site
|
Phase 2/Phase 3 | |
| Completed |
NCT01997619 -
Biological Mesh Repair of Complex Hernias in High Risk Patients
|
N/A |