NCT02488577

Brief Summary

Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

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

June 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

4 years

First QC Date

June 30, 2015

Last Update Submit

September 10, 2018

Conditions

Low Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall percent of postoperative complications.

    the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function.

    30 days

Secondary Outcomes (2)

  • Hospital stay

    30 days

  • Recurrence.

    2 years

Study Arms (2)

TAMIS TME

ACTIVE COMPARATOR

T2 N0 Cases which undergo transanal minimally invasive total mesorectal excision.

Procedure: Transanal minimally invasive total mesorectal excision

TAMIS-Local

ACTIVE COMPARATOR

T2 N0 Cases which will undergo transanal minimally invasive locoregional resection.

Procedure: transanal minimally invasive locoregional resection

Interventions

Transanal minimally invasive total mesorectal excisionPROCEDURE
TAMIS TME
transanal minimally invasive locoregional resectionPROCEDURE
TAMIS-Local

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • T2 N0 low rectal cancer

You may not qualify if:

  • patients unfit for laparoscopic resection
  • Unwilling to share in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sherif Kotb, M.D., PhD.

    Professor of surgical oncology Mansoura university

    STUDY DIRECTOR

  • Osama Eldamshety, PhD

    surgical oncology Mansoura university

    PRINCIPAL INVESTIGATOR

  • Adel Fathi, M.D.

    surgical oncology Mansoura university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of surgical oncology.

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 2, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2019

Study Completion

October 1, 2019

Last Updated

September 12, 2018

Record last verified: 2018-09