PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial
<p>Abstract</p> <p>Background</p> <p>Parastomal hernia is a common complication of a colostomy. Ultimately, one-third of patients with a parastomal hernia will need surgical correction due to frequent leakage or life-threatening bowel obstruction or strangulation. Howev...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2012-11-01
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| Series: | Trials |
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| Online Access: | http://www.trialsjournal.com/content/13/1/226 |
| _version_ | 1818806317358252032 |
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| author | Brandsma Henk-Thijs Hansson Birgitta ME Haan Hilde V-Haaren-de Aufenacker Theo J Rosman Camiel Bleichrodt Rob P |
| author_facet | Brandsma Henk-Thijs Hansson Birgitta ME Haan Hilde V-Haaren-de Aufenacker Theo J Rosman Camiel Bleichrodt Rob P |
| author_sort | Brandsma Henk-Thijs |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Parastomal hernia is a common complication of a colostomy. Ultimately, one-third of patients with a parastomal hernia will need surgical correction due to frequent leakage or life-threatening bowel obstruction or strangulation. However, treatment remains a challenge resulting in high recurrence rates. Two single center trials demonstrated that the frequency of parastomal hernias decreases by prophylactic placement of a mesh around the stoma at the time of formation. Unfortunately, both studies were small-sized, single-center studies and with these small numbers less common complications could be missed which were the reasons to initiate a prospective randomized multicenter trial to determine if a retromuscular, preperitoneal mesh at the stoma site prevents parastomal hernia and does not cause unacceptable complications.</p> <p>Methods</p> <p>One hundred and fifty patients undergoing open procedure, elective formation of a permanent end-colostomy will be randomized into two groups. In the intervention group an end-colostomy is created with placement of a preperitioneal, retromuscular lightweight monofilament polypropylene mesh, and compared to a group with a traditional stoma without mesh. Patients will be recruited from 14 teaching hospitals in the Netherlands during a 2-year period. Primary endpoint is the incidence of parastomal hernia. Secondary endpoints are stoma complications, cost-effectiveness, and quality of life. Follow-up will be performed at 3 weeks, 3 months and at 1, 2, and 5 years. To find a difference of 20% with a power of 90%, a total number of 134 patients must be included. All results will be reported according to the CONSORT 2010 statement.</p> <p>Discussion</p> <p>The PREVENT-trial is a multicenter randomized controlled trial powered to determine whether prophylactic placement of a polypropylene mesh decreases the incidence of a parastomal hernia versus the traditional stoma formation without a mesh.</p> <p>Trial registration</p> <p>The PREVENT-trial is registered at: <url>http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018</url></p> |
| first_indexed | 2024-12-18T19:07:51Z |
| format | Article |
| id | doaj.art-4ef99ee495424d8f91a2c85ba78d7182 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-18T19:07:51Z |
| publishDate | 2012-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4ef99ee495424d8f91a2c85ba78d71822022-12-21T20:56:21ZengBMCTrials1745-62152012-11-0113122610.1186/1745-6215-13-226PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trialBrandsma Henk-ThijsHansson Birgitta MEHaan Hilde V-Haaren-deAufenacker Theo JRosman CamielBleichrodt Rob P<p>Abstract</p> <p>Background</p> <p>Parastomal hernia is a common complication of a colostomy. Ultimately, one-third of patients with a parastomal hernia will need surgical correction due to frequent leakage or life-threatening bowel obstruction or strangulation. However, treatment remains a challenge resulting in high recurrence rates. Two single center trials demonstrated that the frequency of parastomal hernias decreases by prophylactic placement of a mesh around the stoma at the time of formation. Unfortunately, both studies were small-sized, single-center studies and with these small numbers less common complications could be missed which were the reasons to initiate a prospective randomized multicenter trial to determine if a retromuscular, preperitoneal mesh at the stoma site prevents parastomal hernia and does not cause unacceptable complications.</p> <p>Methods</p> <p>One hundred and fifty patients undergoing open procedure, elective formation of a permanent end-colostomy will be randomized into two groups. In the intervention group an end-colostomy is created with placement of a preperitioneal, retromuscular lightweight monofilament polypropylene mesh, and compared to a group with a traditional stoma without mesh. Patients will be recruited from 14 teaching hospitals in the Netherlands during a 2-year period. Primary endpoint is the incidence of parastomal hernia. Secondary endpoints are stoma complications, cost-effectiveness, and quality of life. Follow-up will be performed at 3 weeks, 3 months and at 1, 2, and 5 years. To find a difference of 20% with a power of 90%, a total number of 134 patients must be included. All results will be reported according to the CONSORT 2010 statement.</p> <p>Discussion</p> <p>The PREVENT-trial is a multicenter randomized controlled trial powered to determine whether prophylactic placement of a polypropylene mesh decreases the incidence of a parastomal hernia versus the traditional stoma formation without a mesh.</p> <p>Trial registration</p> <p>The PREVENT-trial is registered at: <url>http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018</url></p>http://www.trialsjournal.com/content/13/1/226Parastomal herniaProphylacticPreventionMeshColostomy |
| spellingShingle | Brandsma Henk-Thijs Hansson Birgitta ME Haan Hilde V-Haaren-de Aufenacker Theo J Rosman Camiel Bleichrodt Rob P PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial Trials Parastomal hernia Prophylactic Prevention Mesh Colostomy |
| title | PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial |
| title_full | PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial |
| title_fullStr | PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial |
| title_full_unstemmed | PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial |
| title_short | PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial |
| title_sort | prevention of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end colostomy the prevent trial study protocol for a multicenter randomized controlled trial |
| topic | Parastomal hernia Prophylactic Prevention Mesh Colostomy |
| url | http://www.trialsjournal.com/content/13/1/226 |
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