NCT02488707

Brief Summary

A prospective study is planned for management of low rectal cancer with the aim of sphincter preservation and improving the oncological outcome of the patients, through comparing of both approaches minimally invasive techniques including transanal total mesorectal excision and laparoscopic intersphincteric resection.

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
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2014

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

February 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 2, 2015

Status Verified

July 1, 2015

Enrollment Period

2 years

First QC Date

June 27, 2015

Last Update Submit

July 1, 2015

Conditions

Rectal Cancer

Keywords

low rectal cancerminimally invasive colorectal surgerytrans-anal endoscopic microsurgeryTEMintersphincteric resectionISRsubtotal intersphincteric resectiontotal intersphincteric resectiontrans-anal trans-abdominal resectionlaparoscopic intersphincteric resectionanal sphincter preservationtotal mesorectal excisionTMETATAlaparoscopic total mesorectal excisionexternal sphincter preservationNeoadjuvant chemo-radiotherapy for rectal cancerfit patients for minimally invasive surgery

Outcome Measures

Primary Outcomes (2)

  • Percent of Intraoperative and postoperative morbidity within 30 days starting from the time of the operation

    within 30 days

  • Hospital stay

    Hospital stay starting from the day of admission till discharge.

    up to 30 days

Study Arms (2)

LISR group

ACTIVE COMPARATOR

Cases which undergo rectal resection with laparoscopic intersphincteric resection.

Procedure: laparoscopic intersphincteric resection (LISR group)

TAMIS Group

ACTIVE COMPARATOR

Cases with rectal cancer which undergo Transanal minimally invasive Total mesorectal excision.

Procedure: Transanal minimally invasive Total mesorectal excision (TAMIS group)

Interventions

laparoscopic intersphincteric resection (LISR group)PROCEDURE

the patient undergo laparoscopic mesorectal excision with high inferior mesenteric vein ligation combined with transanal distal resection of the rectum

Also known as: Laparoscopic total mesorectum excision with coloaanal anastomosis.
LISR group
Transanal minimally invasive Total mesorectal excision (TAMIS group)PROCEDURE

Transanal minimally invasive total mesorectal excision assisted with minilaparoscopy to ligate the inferior mesenteric vessels and splenic flexure mobilization.

TAMIS Group

Eligibility Criteria

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

You may qualify if:

  • Patient with low rectal cancer below 5 cm from the anal verge
  • Fit (Medically and surgically) for laparoscopy.

You may not qualify if:

  • Patient with massive abdominal adhesions
  • Unfit for laparoscopy
  • Unwilling to share in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology centre Of Mansoura University (OCMU)

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Osama eldamshety, PhD

    Assistant Lecturer of surgical oncology

    PRINCIPAL INVESTIGATOR

  • Sherif Kotb, PhD, MD

    Professor of surgical oncology

    STUDY CHAIR

  • Adel Fathi, PhD, MD

    Lecturer of surgical oncology

    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
associate lecturer of surgical oncology

Study Record Dates

First Submitted

June 27, 2015

First Posted

July 2, 2015

Study Start

February 1, 2014

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

July 2, 2015

Record last verified: 2015-07

Locations

EG(1)