Feasibility of a subcutaneous gluteal transposition flap without donor site scar for perineal closure after extralevator abdominoperineal resection for rectal cancer

Feasibility of a subcutaneous gluteal transposition flap without donor site scar for perineal closure after extralevator abdominoperineal resection for rectal cancer - BIOPEX II Pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45650

Enrollment

Registered

2017-12-20

Start date

2017-03-30

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer. Rectal malignancy

Interventions

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.

Abdominoperineal resection

Rectum neoplasms

Wound healing

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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 = 4.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)