NCT02036112

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

November 26, 2013

Last Update Submit

January 12, 2014

Conditions

Rectal Cancer

Keywords

Advanced Lower rectal cancerExtralevator abdominoperineal excisionCircumferential resection marginMorbiditySurvival

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Three years survival postoperatively

    three years

Other Outcomes (1)

  • Three years local recurrence postoperatively

    three years

Study Arms (2)

Individual ELAPE

EXPERIMENTAL

Patients will receive Individual ELAPE technique

Procedure: Individual ELAPE

Conventional ELAPE

EXPERIMENTAL

Patients with advanced lower rectal cancer will receive conventional EALPE technique

Procedure: conventional ELAPE

Interventions

conventional ELAPEPROCEDURE

device

Conventional ELAPE
Individual ELAPEPROCEDURE

device

Individual ELAPE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Related 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.

    PMID: 22920402BACKGROUND

Related Links

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jiagang Han, Professor

    Beijing Chao Yang Hospital

    STUDY DIRECTOR

Central Study Contacts

Jiagang Han, Professor

CONTACT

8613522867841hjg211@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2013

First Posted

January 14, 2014

Study Start

August 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

CN(1)