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

January 12, 2014 updated by: Zhen Jun Wang, Beijing Chao Yang Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Individual ELAPE
Patients will receive Individual ELAPE technique
Procedure: Individual ELAPE
device
EXPERIMENTAL: Conventional ELAPE
Patients with advanced lower rectal cancer will receive conventional EALPE technique
Procedure: conventional ELAPE
device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The perioperative morbidity
Time Frame: 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
three years

Secondary Outcome Measures

Outcome Measure
Time Frame
Three years survival postoperatively
Time Frame: three years
three years

Other Outcome Measures

Outcome Measure
Time Frame
Three years local recurrence postoperatively
Time Frame: three years
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Study Director: Jiagang Han, Professor, Beijing Chao Yang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

August 1, 2016

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

January 12, 2014

First Posted (ESTIMATE)

January 14, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 12, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IELAPE1127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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