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Biological Mesh Closure of the Pelvic Floor After Extralevator Abdomino Perineal Resection for Rectal Cancer
Phase 3 trial testing Biological mesh assisted perineal closure in Rectal Cancer in 104 participants. Completed in 1 September 2015.
| Lead sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 8 March 2013 |
| Primary completion | 1 September 2014 |
| Estimated completion | 1 September 2015 |
| Sites | 1 location across Netherlands |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →
18 and older, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
uncomplicated perineal wound healing is defined as a Souphampton wound score less than II
| Group | Value | 95% CI |
|---|---|---|
| Biological Mesh Closure | 30 | |
| Primary Perineal Closure | 33 |
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Biological Mesh Closure | Primary Perineal Closure |
|---|---|---|---|
| surgical complication | Surgical and medical procedures | — | — |
| Reaction | System | Biological Mesh Closure | Primary Perineal Closure |
|---|---|---|---|
| surgical complication | Surgical and medical procedures | — | — |
Most-reported serious reactions: surgical complication.
Data from ClinicalTrials.gov NCT01927497 adverse events section.
Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of positive margins and improves oncological outcome in distal rectal cancer. However, wider excisions increase wound healing problems and development of perineal hernia. This has resulted in a progressive increase of the use of musculocutaneous flaps and biological meshes associated with a substantial increase of costs, which is not supported by proper data. Objective: The aim of this study is to determine the cost-effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy. Study design: This is a multicenter study in which patients undergoing an eAPR are randomized between standard care using primary closure of the perineum and the experimental arm with assisted closure using a biological mesh. Study population: Patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy. A total number of 104 patients will be randomized. Intervention: The intervention in the experimental arm consists of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Main study parameters/endpoints: The primary endpoint is the percentage of uncomplicated perineal wound healing (Souphampton wound score less than II at day 30). Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both primary perineal closure and biological mesh assisted closure are being performed in daily clinical practise. The potential benefit resulting from participation of the study in patients randomized for biological mesh assisted closure may be a higher chance of uncomplicated perineal wound healing and lower perineal hernia rate. On the other hand, the use of a biological mesh has been associated with increased postoperative pain and seroma formation.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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