NCT02455752

Brief Summary

The study involves the use of Retroperitoneal plane for TME for rectal anterior resection. Through a pilot prospective study, LR-TME will be assessed as one arm study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

May 26, 2015

Last Update Submit

July 16, 2015

Conditions

Total Mesorectal ExcisionLaparoscopic

Keywords

LE-TMELaparoscopic rectal resectionRetroperitoneal resection

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the procedure

    Feasibility of the TME by the retroperitoneal approach.

    1 day

Secondary Outcomes (3)

  • Intraoperative morbidity

    1 day

  • Postoperative morbidity

    Till patient discharge

  • Pathologic report outcome

    7 days

Study Arms (1)

Reroperitoneal Group

ACTIVE COMPARATOR

LE-TME

Procedure: LE-TME

Interventions

LE-TMEPROCEDURE

Retroperitoneal approach for total mesorectal excision

Reroperitoneal Group

Eligibility Criteria

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

You may qualify if:

  • (Rectum, Anal or sigmoid) Malignancy requiring mesorectal excision and Fit for laparoscopic surgery

You may not qualify if:

  • contraindication to laparoscopic surgery-unwilling to participate in the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology center of mansoura university

Al Mansurah, Eldakahlia, 35511, Egypt

Location

Study Officials

  • Osama Eldamshety, PhD

    1-Assistant lecturer of surgical oncology, Mansoura university Egypt. 2-Research Fellow, Policlinico Umberto primo, LA SAPIENZA, Roma, Italy.

    PRINCIPAL INVESTIGATOR

  • Frédéric Dumont, M.D.

    1- Department of Digestive Oncological surgery, West oncologic center, Nantes, France 2- Department of digestive Oncological surgery, Gustave Roussy Cancer Campus, Villejuif, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Lecturer of surgical oncology

Study Record Dates

First Submitted

May 26, 2015

First Posted

May 28, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

EG(1)