NCT02468362

Brief Summary

Through a double blinded study, patients with low rectal cancer will be randomized into two equal groups to compare between the 5 year disease free survival as a primary outcome measure.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_2

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

April 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

5 years

First QC Date

June 7, 2015

Last Update Submit

June 9, 2015

Conditions

Low Rectal Cancer

Keywords

Intersphincteric resectionlaparoscopic rectal rescetiontotal mesorectal excsison

Outcome Measures

Primary Outcomes (1)

  • Disease Free survival

    5 years

Secondary Outcomes (3)

  • Local recurrence

    5 years

  • Distant metstasis

    5 years

  • 5 year survival

    5 years

Study Arms (2)

Laparoscopic group

ACTIVE COMPARATOR
Procedure: laparoscopic intersphincteric resection

Open group

ACTIVE COMPARATOR
Procedure: open intersphincteric resection

Interventions

laparoscopic intersphincteric resectionPROCEDURE

laparoscopic intersphincteric resection for low rectal cancer

Laparoscopic group
open intersphincteric resectionPROCEDURE
Open group

Eligibility Criteria

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

You may qualify if:

  • Low rectal cancer below 5 cm from the anal verge
  • Fit for laparoscopic total mesorectal excsion
  • T2, T3 rectal cancer
  • No distant metstasis

You may not qualify if:

  • T1, AND T4
  • Distant metastasis
  • Tumor infiltrating the dentate line
  • unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Osama Eldamshety, PhD, MD

    Oncology centre of mansoura university

    PRINCIPAL INVESTIGATOR

  • Sherif Kotb, PhD, MD

    Oncology centre of mansoura university

    PRINCIPAL INVESTIGATOR

  • Nazem Shams, PhD, MD

    Oncology centre of mansoura university

    PRINCIPAL INVESTIGATOR

  • Ashraf Khater, Phd, MD

    Oncology centre of mansoura university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
surgical oncology

Study Record Dates

First Submitted

June 7, 2015

First Posted

June 10, 2015

Study Start

April 1, 2014

Primary Completion

April 1, 2019

Study Completion

October 1, 2019

Last Updated

June 10, 2015

Record last verified: 2015-06