Abdominoperineal Resection, Rectal Cancer, Wound Heal
Conditions
Brief summary
Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial. Previous studies on synthetic mesh repair on perineum are almost lacking.
Detailed description
The objective of this pilot study is to assess the feasibility and the potential benefits of synthetic mesh reconstruction in perineum in case-control setting. 30 subjects will be prospectively enrolled to this study as intervention group. Controls matched with age, gender and preoperative radiotherapy are selected from retrospective data collected from Oulu University database and operated for rectal adenocarcinoma 2009-2017 with otherwise identical methods.
Interventions
DEVICEComposite mesh
Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.
Sponsors
Elisa Mäkäräinen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Abdominoperineal resection and permanent colostoma
Exclusion criteria
* Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5) * Potentially curable resection not possible * Patient undergoing emergency procedure * Metastatic disease * Pregnant or suspected pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Complication index | 30 days | Comprehensive Complication index is used to evaluate outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation rate | 30 days | Reoperations during primary stay at the hospital |
| Operative time | 30 days | Operative time |
| Length of stay | 30 days | Length of stay at the hospital during primary operation and recovery |
| Surgical site infection | 30 days | Surgical site infection classified by Clavien-Dindo score |
| Total perineal healing time | 30 days | Time to point when perineum is closed and healed |
| Perineal sinus | 30 days | Presence of perineal sinus at 30 days follow-up |
| Perineal hernia | 12 months | Perineal hernia by CT scan at 12 months follow-up |
| Costs | 30 days | Costs by materials used |
Countries
Finland
Outcome results
None listed