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

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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)

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

Trial contacts and locations

1

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Central trial contact

Jiagang Han, Professor

Data sourced from clinicaltrials.gov

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