Clinical trial NCT02036112: Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer
Official title: Randomized Clinical Trial of Conventional Versus Individual Extralevator Abdominoperineal Excision for Locally Advanced Lower Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: Advanced Lower rectal cancer
Extralevator abdominoperineal excision
Circumferential resection margin
Morbidity
Survival
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The perioperative morbidity
timeFrame: three years
Secondary outcomes:
measure: Three years survival postoperatively
timeFrame: three years
Other outcomes:
measure: Three years local recurrence postoperatively
timeFrame: three years
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Jiagang Han, Professor
role: STUDY_DIRECTOR
References:
citation: Han JG, Wang ZJ, Wei GH, Gao ZG, Yang Y, Zhao BC. Randomized clinical trial of conventional versus cylindrical abdominoperineal resection for locally advanced lower rectal cancer. Am J Surg. 2012 Sep;204(3):274-82. doi: 10.1016/j.amjsurg.2012.05.001.