The aim of this study is to determine the cost-effectiveness of pelvic floor reconstruction using a biological mesh afterstandardized eAPR with neo-adjuvant (chemo)radiotherapy.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of uncomplicated perineal wound healing (Souphampton wound score
less than II on
day 30).
Secondary outcome
Hospital stay, incidence of perineal hernia, quality of life, and costs.
Background summary
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 improve
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.
Study 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.
Intervention
The intervention in the experimental arm consists of suturing an acellular
biological mesh derived from porcine dermis in the
pelvic floor defect, followed by perineal closure similar to the control arm.
Study burden and risks
Potential additional risk related to the use of biological mesh is increased
postoperative pain and seroma formation, which is mostly transient and does not
require invasive treatment. The extra burden of participation consists of
additional questionnaires.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
(1) Primary rectal cancer
(2) Age of 18 years or higher
(3) Planned for extralevator abdominoperineal excision after neo-adjuvant (chemo)radiotherapy
(4) Life expectancy of more than 2 years
(5) Ability to return for all scheduled and required study visits
(6) Written informed consent for study participation
Exclusion criteria
(1) Previous pelvic irradiation for other cancers (i.e. prostate cancer)
(2) Total exenteration or sacral resection above level S4/S5)
(3) Sensitivity to porcine derived products or polysorbate
(4) Severe systemic diseases affecting wound healing
(5) The patient has a collagen diseases
(6) Participation of the patient in other scientific research affecting wound healing
(7) Non-correctable coagulopathy (INR>2; or platelets <90E9 109/l) present
(8) ASA-classification * 4
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01927497 |
| CCMO | NL42094.018.12 |
| OMON | NL-OMON26577 |