Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer (ELAPE)

Capital Medical University

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: conventional ELAPE; Procedure: Individual ELAPE

Study type: Interventional

Funder types: Other

Identifiers

NCT02036112

IELAPE1127

Details and patient eligibility

About

An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE.

Full description

We suppose that the ELAPE technique may be performed according to individual conditions. For the rectal tumors suitable for ELAPE, most of them were circular or nearly circular infiltrating tumors. Patients with these rectal tumors should receive full ELAPE resection. In those rectal tumors not involving the levator ani muscle, the dissection plane may continue close to the external anal sphincter and the levator ani muscle, leaving the ischioanal fat and the terminal branches of the pudendal nerve intact.If the tumor has only penetrated into 1 side of the levator ani muscle, the dissection might include the levator ani muscle and the fat of the ischioanal fossa on the side of the tumor to achieve a clear circumferential resection margin, whereas the ischioanal fat and levator ani muscle on the other side of the tumor may be left

. This individual ELAPE may be as effective as conventional ELAPE while minimizing the operative trauma and the damage to the nerves of the genital organs.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Tumor within 5 cm of the anal verge or with a very narrow pelvis
• T3-T4 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination or a low tumor is fixed or tethered at rectal examination
• Absence of distant metastases
• Absence of intestinal obstruction

Exclusion criteria

• T1-T2 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination
• With distant metastases
• With intestinal obstruction
• Pregnancy or lactation
• Allergic constitution to heterogeneous protein
• With operation contraindication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Individual ELAPE

Experimental group

Description:

Patients will receive Individual ELAPE technique

Treatment:

Procedure: Individual ELAPE

Conventional ELAPE

Experimental group

Description:

Patients with advanced lower rectal cancer will receive conventional EALPE technique

Treatment:

Procedure: conventional ELAPE