Gluteal turnover flap for closure of the perineal wound after abdominoperineal resection for rectal cancer, BIOPEX 2-study

Gluteal turnover flap for closure of the perineal wound after abdominoperineal resection for rectal cancer, BIOPEX 2-study - BIOPEX 2-study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52518

Enrollment

160

Registered

2019-05-14

Start date

2019-06-11

Completion date

Unknown

Last updated

2024-04-15

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

Surgery can start with the abdominal or the perineal phase. The abdominal phase of the APR can be performed via either laparoscopic or open surgery. The perineal phase of the APR will be performed a

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: (1) Resection of primary or recurrent rectal carcinoma by abdominoperineal resection. (2) Age of 18 years or older. (3) Ability to return for all scheduled and required study visits. (4) Written informed consent.

Exclusion criteria

Exclusion criteria: (1) The patient will undergo an intersphincteric abdminoperineal resection. (2) Total pelvic exenteration or sacral resection above level S4/S5. (3) Severe systemic diseases affecting wound healing except diabetes (i.e. renal failure requiring dialysis, liver cirrhosis, and immune compromised status like HIV). (4) Collagen disorders (i.e. the syndrome of Marfan). (5) Enrolment in trials with overlapping primary endpoint.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the percentage of uncomplicated perineal wound healing defined as a Southampton wound score of less than II at 30 days postoperatively.	—

Secondary

Measure	Time frame
1.) Surgery characteristics (duration of surgery, complications) 2.) Effect of neoadjuvant treatment on PTP-flap healing 3.) Perineal wound healing according to the Southampton wound grading at 14 days, 3, 6 and 12 months postoperatively. 4.) Cosmetic outcome and satisfaction with result . 5.) Incidence of persistent perineal or presacral sinuses, both clinically and by imaging (routine follow-up CT). 6.) Need for re-intervention or re-admission related to pre-sacral abscess or other perineal wound problems. 7.) Length of hospital stay. 8.) Incidence of symptomatic and asymptomatic perineal hernia during follow-up. 9.) Quality of life and urogenital function (EQ 5D-5L, EORTC-QLQ-C30-QL2, EORTC-QLQ-CR29, SF36, UDI6, IIQ7, IIEF, FSDS-R, FSFI). 10.) Postoperative pain score and duration. 11.) Serious adverse events rate.	—

Measure

Time frame

1.) Surgery characteristics (duration of surgery, complications) 2.) Effect of neoadjuvant treatment on PTP-flap healing 3.) Perineal wound healing according to the Southampton wound grading at 14 days, 3, 6 and 12 months postoperatively. 4.) Cosmetic outcome and satisfaction with result . 5.) Incidence of persistent perineal or presacral sinuses, both clinically and by imaging (routine follow-up CT). 6.) Need for re-intervention or re-admission related to pre-sacral abscess or other perineal wound problems. 7.) Length of hospital stay. 8.) Incidence of symptomatic and asymptomatic perineal hernia during follow-up. 9.) Quality of life and urogenital function (EQ 5D-5L, EORTC-QLQ-C30-QL2, EORTC-QLQ-CR29, SF36, UDI6, IIQ7, IIEF, FSDS-R, FSFI). 10.) Postoperative pain score and duration. 11.) Serious adverse events rate.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)