NCT02812628

Brief Summary

This study is designed to compare the short-term and long-term benefits between conventional laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal individualized levator transection (TILT).

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
528

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 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

December 1, 2012

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

7.5 years

First QC Date

June 10, 2016

Last Update Submit

June 21, 2016

Conditions

Rectal Cancer

Keywords

laparoscopic surgeryabdominoperineal resectionrectal cancerindividualized surgerylevator muscle

Outcome Measures

Primary Outcomes (1)

  • 3-year local recurrence

    3 years post operation

Secondary Outcomes (2)

  • 3-year overall survival

    3 years post operation

  • 3-year disease-free survival

    3 years post operation

Other Outcomes (4)

  • Operative time for perineal dissection

    1 month post operation

  • Numbers of days to remove the urinary catheter after surgery

    1 month post operation

  • Circumferential Resection Margin (+) rate

    1 month post operation

  • +1 more other outcomes

Study Arms (2)

Conventional LAPR

ACTIVE COMPARATOR

Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).

Procedure: LAPR

LAPR-TILT

EXPERIMENTAL

Patients undergoing LAPR with transabdominal individualized levator transection (TILT).

Procedure: LAPR-TILT

Interventions

LAPRPROCEDURE

Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.

Conventional LAPR
LAPR-TILTPROCEDURE

Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.

LAPR-TILT

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed as having rectal cancer ≤5cm from anal verge by colonoscopy.
  • Patients undergoing elective, radial surgery with no distant metastasis.
  • Patients with Body Mass Index (BMI) between 18-30kg/m2.
  • Patients who agree to undergo standard adjuvant treatment after surgery.
  • Patients who have fully understood the aim of the trial and have signed the written informed consent.

You may not qualify if:

  • Patients with distant metastasis, tumor infiltrating to adjacent organs, or recurrent tumors.
  • Patients undergoing emergent surgery.
  • Pregnant patients.
  • Patients with tumors other than rectal tumor.
  • Patients with severe comorbid diseases which preclude surgery.
  • Patients in bad conditions and do not ameliorate before surgery.
  • Patients undergoing other procedures to treat rectal cancer, eg. L-Dixon, L-Hartmann or Parks surgery.
  • Patients who refuse to accept standard adjuvant surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bo Feng, Ph.D

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Feng, M.D. Ph.D

CONTACT

86-21-64370045fengbo2022@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent professor of surgery

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 24, 2016

Study Start

December 1, 2012

Primary Completion

June 1, 2020

Study Completion

June 1, 2022

Last Updated

June 24, 2016

Record last verified: 2016-06

Locations

CN(1)