The aim of this study is to determine feasibility of perineal reconstruction using a gluteal subcutaneous transposition flap (Luna flap) after eAPR for rectal cancer.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is flap failure at 30 days postoperatively. Vascularization
cannot be checked postoperatively in the absence of a skin island, because the
flap is deepithelialized and the adjacent perineal skin is closed over the flap
in the midline. Therefore, flap failure will be determined by its secondary
impact on perineal wound healing. Flap necrosis will result in tissue
breakdown, which is defined as a Southampton wound score of 5.
Secondary outcome
Secondary endpoints include uncomplicated perineal wound healing rate defined
as a Southampton wound score of less than 2, and treatment related morbidity
defined as Clavien-Dindo score of three or higher on day 30. Other outcome
parameters include operative time needed for perineal closure, postoperative
pain at 30 days postoperatively, hospital stay and perineal wound related
re-intervention and re-admission.
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 improves oncological outcome in distal rectal
cancer. However, wider excisions increase wound healing problems. 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. In addition the use of muscle flaps is associated
with a risk of donor site morbidity.
Study objective
The aim of this study is to determine feasibility of perineal reconstruction
using a gluteal subcutaneous transposition flap (Luna flap) after eAPR for
rectal cancer.
Study design
This is a Pilot study in which patients undergoing an eAPR are treated with
closure of the perineum using a Luna flap, after which the skin will be closed
over the flap in the midline. The study will be conducted in two academic
centers (AMC and Erasmus MC).
Intervention
The intervention consists of harvesting and stitching a subcutaneous
transposition flap into the pelvic dead space, followed by perineal closure
over the flap in the midline.
Study burden and risks
A potential additional risk related to the use of a Luna flap is flap failure,
which may require a reoperation. However, this risk is considered to be low,
based on our experience with fasciocutaneous gluteal transposition flaps in
which the risk of flap necrosis is negligible.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
(1) Rectal cancer (including recurrence). (2) Age of 18 years or higher. (3) Planned for extralevator abdominoperineal resection (4) Written informed consent for study participation.
Exclusion criteria
(1) Total exenteration or sacral resection above level S4/S5)
(2) Severe systemic diseases affecting wound healing
(3) The patient has a collagen diseases
(4) Participation of the patient in other scientific research affecting wound healing
(5) Non-correctable coagulopathy (INR>2; or platelets <90E9 109/l) present
(6) ASA-classification >= 4.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58380.018.16 |