Clinical trial · Interventional
Prestoma-Trial for Parastomal Hernia Prevention
PRESTOMA- A Prospective Randomized Controlled Multicenter Trial Comparing Three Meshes for Prevention of Parastomal Hernia After Abdominoperineal Resection for Rectal Adenocarcinoma
NCT03527784CI-TRIAL-00035615terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Parastomal Parietex withdrawn from market by the manufacturer.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dynamesh IPST | Device | — | UNRESOLVED |
| Parietene Macro | Device | — | UNRESOLVED |
| Parietex Parastomal | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Parietene Macro
- description
- Parietene Macro is a macroporous synthetic mesh.
- interventionNames
- Device: Parietene Macro
- type
- ACTIVE_COMPARATOR
- label
- Parietex Parastomal
- description
- Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments.
- interventionNames
- Device: Parietex Parastomal
- type
- ACTIVE_COMPARATOR
- label
- Dynamesh IPST
- description
- Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Abdominoperineal resection for rectal cancer with permanent end colostomy, either by laparoscopic technique or robotic assistance * 18 years or older * Patient has a life expectancy of at least 12 months. * Patient signs the Informed consent and agrees to attend all study visits. Exclusion Criteria: * Abdominoperineal resection by laparotomy or conversion to laparotomy * Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4-5). * Patients with concurrent or previous malignant tumors within 5 years before study enrollment * Patients with T4b tumors which impose a multi-organ resection * Rectal malignancy other than adenocarcinoma * Potentially curable resection not possible * Patient undergoing emergency procedures * Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections). * Metastatic disease with life expectancy of less than 1 year * Pregnant or suspected pregnancy * Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.