Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472537
Status:
COMPLETED
Last Update Posted:
2013-04-24
First Post:
2007-05-10
Brief Title:
ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment
Sponsor:
Skane University Hospital
Organization:
Skane University Hospital
Study Overview
Official Title:
Prospective Randomized Evaluation of Open vs Laparoscopic Operation of Ventral Incisional Eventrations A Swedish Multicenter Study
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProLOVE
Brief Summary:
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
Detailed Description:
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 138 weeks post operation and after 12 months
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 138 weeks post operation and after 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 200-06-005 | None | None | None |