Clinical trial · Interventional
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
NCT03445936CI-TRIAL-00073519active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
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 |
|---|---|---|---|
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Parietene Macro | Device | — | UNRESOLVED |
| Permacol | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Parietene Macro
- description
- Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
- interventionNames
- Device: Parietene Macro
- type
- ACTIVE_COMPARATOR
- label
- Permacol
- description
- Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
- interventionNames
- Device: Permacol
Primary outcomes (2)
- measure
- Surgical site infection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma * 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: * Patient with a comorbid illness or condition that would precluded 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 imposed a multi-organ resection * Patient undergone emergency procedures * Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections). * Metastatic disease with life expectancy of less than 12 months * Pregnancy or suspected pregnancy
References
Publications (1)
- DERIVEDMakarainen EJ, Wiik HT, Kossi JAO, Pinta TM, Mantymaki LJ, Mattila AK, Nikki MJ, Jarvinen JE, Ohtonen PP, Rautio TT. Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial). Br J Surg. 2024 Jan 3;111(1):znad362. doi: 10.1093/bjs/znad362. PMID 37944025