Conventional Versus Individual Extralvator Abdominoperineal Excision for Advanced Lower Rectal Cancer

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: conventional ELAPE; Procedure: Individual ELAPE

• Registration Number: NCT02036112
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-11-26
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-12
• Last Update Submitted: 2014-01-12
• Study First Posted: 2014-01-14
• Last Update Posted: 2014-01-14
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ELAPE	conventional ELAPE	Patients with advanced lower rectal cancer will receive conventional EALPE technique
Individual ELAPE	Individual ELAPE	Patients will receive Individual ELAPE technique

Primary Outcome Measures

Name	Time	Method
The perioperative morbidity	three years	Sexual dysfunction,Urinary retention，Chronic perineal pain，Perineal wound infection，Urinary system infection，Pulmonary infection，Perineal seroma，Peristomal hernia，Abdominal wound infection，Perineal herniation

Secondary Outcome Measures

Name	Time	Method
Three years survival postoperatively	three years

Trial Locations

Locations (1)

Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China