Cost-effectiveness of biological mesh closure of the pelvic floor after rectal cancer surgery. De kosten-effectiviteit van een biologische mat voor het sluiten van de bekkenbodem na operatie voor laag gelegen endeldarm kanker.

Cost-effectiveness of biological mesh closure of the pelvic floor after extralevator abdominoperineal resection for rectal cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26577

Enrollment

104

Registered

2012-11-23

Start date

2013-03-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Wound healing, Extralevator abdominoperineal resection, Biological mesh, Rectal cancer, Perineal hernia extralevatoire abdominoperineale resectie, rectumcarcinoom, biologische mat, wondgenezing, perineale hernia

Interventions

The perineal phase of the APR will be performed according to the principles of an extralevator APR. Preferably, an omental plasty is positioned in the pelvic cavity following resection. The interven

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primary rectal cancer scheduled for eAPR after neo-adjuvant (chemo)radiotherapy; 2. Age of 18 years or higher; 3. Life expectancy of more than 2 years; 4. Ability to return for all scheduled and required study visits; 5. Written informed consent for study participation.

Exclusion criteria

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 (i.e. renal failure requiring dialysis, liver cirrhosis, immune compromised status like HIV); 5. Collagen disorders (i.e. Marfan); 6. Enrollment in trials with overlapping primary endpoint or otherwise expected influence on wound healing (i.e. biological therapy like antiangiogenic agents).

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Perineal wound healing according to the Southampton wound grading at 3, 6, 9 and 2 months postoperatively; 2. Incidence of persistent perineal or presacral sinuses, both clinically and by imaging (routine follow-up CT); 3. Need for re-intervention or re-admission related to pre-sacral abscess or other perineal wound problems; 4. Length of hospital stay; 5. Need for nursing home admission; 6. Need for home nursing wound care: Frequency per week and total period of time; 7. Use of wound care material and devices like vacuum assisted closure; 8. Incidence of symptomatic and asymptomatic perineal hernia at 3, 6, 9 and12 months of follow-up; 9. Quality of life (EQ-5D, EORTC-30); 10. Costs.	—

Measure

Time frame

1. Perineal wound healing according to the Southampton wound grading at 3, 6, 9 and 2 months postoperatively; 2. Incidence of persistent perineal or presacral sinuses, both clinically and by imaging (routine follow-up CT); 3. Need for re-intervention or re-admission related to pre-sacral abscess or other perineal wound problems; 4. Length of hospital stay; 5. Need for nursing home admission; 6. Need for home nursing wound care: Frequency per week and total period of time; 7. Use of wound care material and devices like vacuum assisted closure; 8. Incidence of symptomatic and asymptomatic perineal hernia at 3, 6, 9 and12 months of follow-up; 9. Quality of life (EQ-5D, EORTC-30); 10. Costs.

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Contacts

Public ContactG.D. Musters

Department of surgery, G4-140 Academic Medical Center Postbox 22660

G.D.Musters@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)