HERNIA, VENTRAL Clinical Trial
Official title:
Prospective Randomized Evaluation of Open vs. Laparoscopic Operation of Ventral Incisional Eventrations. A Swedish Multicenter Study
This purpose of this study is to compare the recovery after an operation of an incisional hernia within the limits of the rectus muscles of the abdominal wall. The use of a mesh in the repair of a postoperative hernia is considered obligatory. Placement of a retromuscular mesh is done by open or laparoscopic surgery. Focus is on the recovery phase assuming a less painful recovery after a laparoscopic procedure.
Incisional ventral hernia after abdominal surgery is a fairly common condition. In recent
years the use of a prosthesis in the repair procedure has proved very effective in
preventing a new hernia. A retromuscular mesh placement seems to have superior results. The
mesh may be placed retromuscular through an open surgical procedure or through a
laparoscopic procedure in an intra-abdominal position. Both procedures are highly
standardized. A heavy weight mesh is used in the open procedure, fixed in the midline only,
and a composite mesh is used intraabdominally and fixed only with titanium tackers.
SF-36 is used to assess the quality of life, and its subscale BP (bodily pain) is used as
primary outcome 3 weeks postoperatively. Secondary endpoints are return to daily life, pain,
complications, recurrence, patient satisfaction and cosmetic outcome.
Subjects are assessed at 1,3,8 weeks post operation and after 12 months.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06051578 -
Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
|
||
| Recruiting |
NCT04098380 -
Small Versus Large Bite Closure of Emergency Midline Laparotomy
|
N/A | |
| Completed |
NCT02616718 -
Incisional Hernia Progression Over Time
|
N/A | |
| Completed |
NCT06034652 -
T-GENVIH-003 LTFU (Long Term Follow Up) Study
|
||
| Completed |
NCT04222517 -
The Use of Local Hemostatic in Patients With Large Incisional Hernias
|
N/A | |
| Completed |
NCT00749268 -
AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
|
Phase 4 | |
| Not yet recruiting |
NCT05467124 -
Enhanced Recovery After Abdominal Wall Reconstruction
|
||
| Active, not recruiting |
NCT02365194 -
Modifying Risk in Ventral Hernia Patients
|
N/A | |
| Recruiting |
NCT04718168 -
GORE® ENFORM Biomaterial Product Study
|
N/A | |
| Completed |
NCT02594241 -
PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial
|
N/A | |
| Active, not recruiting |
NCT02363790 -
Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial
|
N/A | |
| Completed |
NCT02398565 -
Pregnancy Subsequent to Ventral Hernia Repair
|
N/A | |
| Terminated |
NCT02041494 -
Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh
|
N/A | |
| Completed |
NCT00532870 -
Laparoscopic Intraperitoneal Mesh Repair of Ventral Hernia: Comparison to Conventional Mesh Repair
|
N/A | |
| Completed |
NCT05320055 -
Pain and Readmission After Lap IPOM vs. Robotic Ventral Hernia Repair
|
||
| Completed |
NCT04229940 -
Peritoneal in Laparoscopic Ventral Hernia Repair 2
|
Phase 2 | |
| Completed |
NCT05446675 -
Endoscopic eTEP Versus Open Rives-Stoppa
|
||
| Completed |
NCT05912868 -
Endoscopic Mini/Less Open Sublay(EMILOS) Repair
|
||
| Not yet recruiting |
NCT06449378 -
Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia
|
N/A | |
| Withdrawn |
NCT04143776 -
Renal- and Pulmonary Function in Relation to Abdominal Hypertension After Abdominal Reconstruction
|