Rectal Cancer
Conditions
Keywords
abdominoperineal resection, perineal reconstruction
Brief summary
The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.
Detailed description
Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.
Interventions
PROCEDUREGluteus plasty enhanced with Progrip self gripping mesh
Intervention group will be compared to historical patients in a case-control setting. Intervention group will have a mesh enhanced gluteus plasty made to reconstruct perineum after abdominoperineal resection.
Sponsors
University of Oulu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients, who have an abdominoperineal reconstruction for rectal cancer, will have a mesh enhanced gluteus plasty. The patients will be compared to historical cohort.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Curative intent abdominoperineal resection and permanent colostomy
Exclusion criteria
* Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5) * Immunosupression (cortisone \>10mg/day) or severe malnutrition (BMI \<20) * Diabetes with 1 or more organ damage * Dialysis treatment * Hepatic cirrhosis Child-Bugh B-C * Potentially curable resection not possible * Patient undergoing emergency procedures * Metastatic disease * Vaginal resection, pelvic exenteration and sacrum resection * Vaginal perforation * Pelvic abscess or perforated tumor * Pregnant or suspected pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 30 days | Comprehensive complication index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation rate | 30 days | Reoperation rate |
| Operative time | 30 days | Operative time to reconstruct perineum |
| Length of hospital stay | 30 days | Primary length of stay at the hospital |
| Costs of treatment materials | 30 days | Costs of treatment materials |
| Surgical site infections | 30 days | Surgical site infections |
| Perineal fistula | 30 days | Perineal sinus or fistula |
| Perineal hernia | 12 months | Perineal hernia incidence |
| Gluteus muscle function measured by time stands test | 12 months | Gluteus muscle function measured by time stands test |
| Total perineal healing time | 1 year | Time from operation to complete perineal healing |
Countries
Finland
Outcome results
None listed