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The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.
Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.
Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic mesh | Active Comparator | All patients will have a permanent ostomy and a randomisation with prophylactic mesh |
|
| without prophylactic mesh | No Intervention | All patients will have a permanent ostomy and a randomisation without prophylactic mesh |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh | Device | Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh |
|
| Measure | Description | Time Frame |
|---|---|---|
| If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done | 24 to 36 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring the quality of life using the SF-36 | Preoperative and at the end of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Valldhebron Research Institute | Barcelona | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19300232 | Background | Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, Mora-Lopez L, Alcantara-Moral M, Ayguavives-Garnica I, Navarro-Soto S. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg. 2009 Apr;249(4):583-7. doi: 10.1097/SLA.0b013e31819ec809. | |
| 19502871 | Background |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Lopez-Cano M, Lozoya-Trujillo R, Espin-Basany E. Prosthetic mesh in parastomal hernia prevention. Laparoscopic approach. Dis Colon Rectum. 2009 May;52(5):1006-7. doi: 10.1007/DCR.0b013e31819a6a58. |
| 22782367 | Derived | Lopez-Cano M, Lozoya-Trujillo R, Quiroga S, Sanchez JL, Vallribera F, Marti M, Jimenez LM, Armengol-Carrasco M, Espin E. Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial. Hernia. 2012 Dec;16(6):661-7. doi: 10.1007/s10029-012-0952-z. Epub 2012 Jul 11. |