Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer

Rectal Cancer Clinical Trial

— ELAPE  

Official title:

Randomized Clinical Trial of Conventional Versus Individual Extralevator Abdominoperineal Excision for Locally Advanced Lower Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02036112
• Other study ID #: IELAPE1127
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2013
• Last updated: January 12, 2014
• Start date: August 2013
• Est. completion date: August 2016

Study information

• Verified date: January 2014
• Source: Beijing Chao Yang Hospital
• Contact: Jiagang Han, Professor
• Phone: 8613522867841
• Email: hjg211[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• conventional ELAPE
device
• Individual ELAPE
device

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Three years local recurrence postoperatively		three years	Yes
Primary	The perioperative morbidity	Sexual dysfunction,Urinary retention,Chronic perineal pain,Perineal wound infection,Urinary system infection,Pulmonary infection,Perineal seroma,Peristomal hernia,Abdominal wound infection,Perineal herniation	three years	Yes
Secondary	Three years survival postoperatively		three years	Yes

External Links

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