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Parastomal Parietex withdrawn from market by the manufacturer.
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Prestoma Trial is designed to compare the safety and efficiency of three different meshes and techniques to prevent parastomal hernia after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.
Parastomal hernia after permanent colostomy formation is a common problem. The European Hernia Society recommends the use of prophylactic mesh when the stoma is constructed. So far, there're no trials comparing the methods to prevent the parastomal hernia.
Prestoma Trial is designed to compare the most researched retromuscular mesh (Parietene Macro by Medtronic) with two different types of intraperitoneal meshes (Parietex Parastomal by Medtronic and Dynamesh IPST) in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parietene Macro | Active Comparator | Parietene Macro is a macroporous synthetic mesh. |
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| Parietex Parastomal | Active Comparator | Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments. |
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| Dynamesh IPST | Active Comparator | Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parietene Macro | Device | Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of parastomal hernia | The primary outcome is incidence of parastomal hernia at 12 months follow up, detected clinically or on CT scan. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical infections | Surgical infections due to primary surgery, defined by CDC (Centers for Disease Control) definition for surgical site infection. | 30 days |
| Complications | The incidence of complications defined by Clavien-Dindo Classification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisa Mäkäräinen-Uhlbäck, M.D. | Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland | ||||
| Jyväskylä Central Hospital |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Prestoma is a prospective randomized controlled multicenter trial.
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Subject is blinded of the mesh used. Outcome at 12 month follow-up is assessed by surgeon who was not involved in the operation.
| Parietex Parastomal | Device | Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia. |
|
| Dynamesh IPST | Device | Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia |
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| 30 days |
| Stoma related complications | Any complications related to stoma | 5 years |
| Reoperation rate | Reoperation needed for any reason related to previous surgery | 5 years |
| Operative time | Total time needed in operation theatre and time needed for mesh application | 30 days |
| Length of stay | Length of stay at the hospital. | 30 days |
| Quality of Life measured by RAND 36 | Quality of life measured by The RAND 36-Item Health Survey 1.0 which assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions with a scale 0-100, higher the score, better the quality of life. | 5 years |
| Jyväskylä |
| Finland |
| Oulu University Hospital | Oulu | Finland |
| Seinäjoki Central Hospital | Seinäjoki | Finland |
| Tampere University Hospital | Tampere | Finland |
| Turku University Hospital | Turku | Finland |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |