💬In plain words
What the trial is, and whether it could suit you
Abdomino-perineal resection is a surgical procedure involving the removal of the rectum and anus via abdominal and perineal approaches. During this procedure, a terminal colostomy is created and the perineum is closed. This procedure is indicated for patients with non-metastatic adenocarcinoma of the lower and very lower rectum (where preservation of the sphincter apparatus is not possible) or squamous cell carcinoma of the anal canal that does not respond to chemoradiotherapy.
Most often, treatment for non-metastatic adenocarcinoma of the lower and very lower rectum is part of a therapeutic sequence that includes neoadjuvant chemoradiotherapy followed by surgery 7 to 12 weeks later. Recently, the GRECCAR group (Rectal Surgery Research Group) published the results of the Prodigy 23 study demonstrating the benefit of intensification chemotherapy prior to neoadjuvant chemoradiotherapy.
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Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Adult patient;
* Patient scheduled to undergo abdominoperineal resection for adenocarcinoma of the lower and very lower rectum following chemoradiotherapy (50 Gy over 5 weeks);
* Patients capable of following the clinical trial protocol and who have provided written informed consent to participate in the clinical trial;
* Patients enrolled in the social security system or eligible for coverage;
Exclusion Criteria:
* Patients scheduled to undergo a salvage abdominoperineal resection for squamous cell carcinoma following chemoradiotherapy;
* Patients scheduled to undergo an abdominoperineal resection for adenocarcinoma of the very low rectum without neoadjuvant therapy;
* Patients with a known allergy to the dressing;
* Patients with a contraindication to the use of the PICO 7® dressing:
* Malignancy within the wound bed or at the wound margins;
* Previously confirmed, untreated osteomyelitis;
* Non-enteric, unexplored fistulas;
* Necrotic tissue with pressure ulcers;
* Exposed arteries, veins, nerves, or organs;
* Exposed anastomotic sites;
* Patients participating in another clinical research protocol that could affect the objectives of this clinical trial;
* Patients already randomized in this clinical trial;
* Pregnant patients, women in labor, breastfeeding women, or women of childbearing age not using effective contraception\*;
* Patients under guardianship, conservatorship, or deprived of their liberty;
* Patients under an activated future protection order;
* Patients under family authorization;
* Patients under judicial protection.
💊
What it tests
- Direct perineal skin suturing with negative pressure wound therapy (PICO 7®)
- Direct perineal skin suture
Chu Amiens
Amiens, France
Chu Angers
Angers, France
Chd Vendee
La Roche-sur-Yon, France
Hospital Saint Antoine (Aphp)
Paris, France
Chu Rennes
Rennes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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