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CompletedNCT02455752LE-TMEUpdated Jul 17, 2015

Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.

An interventional study of LE-TME in Total Mesorectal Excision and Laparoscopic, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-17.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

This study is based on our new suggested theory for a retro-peritoneal approach. After successful 2 cases of Laparoscopic extraperitoneal-TME. A pilot study for assessment of the feasibilty of the new approach.

Data will be registered prospectively and the perioperative outcomes will be assessed.

02

Conditions studied

  • Total Mesorectal Excision
  • Laparoscopic

Keywords

  • LE-TME
  • Laparoscopic rectal resection
  • Retroperitoneal resection
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • contraindication to laparoscopic surgery-unwilling to participate in the clinical trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Active comparator
    Reroperitoneal Group

    LE-TME

    Procedure: LE-TME

Interventions

  • ProcedureLE-TME

    Retroperitoneal approach for total mesorectal excision

06

What researchers measure

Primary outcomes

  1. Feasibility of the procedure

    Feasibility of the TME by the retroperitoneal approach.

    Time frame: 1 day

Secondary outcomes

  1. Intraoperative morbidity

    Intraoperative morbidity including Urteric injury, Vascular injuries, hypogastric nerve injury, intestinal loop injury.

    Time frame: 1 day

  2. Postoperative morbidity

    Postoperative haematoma, colonic leak and/or necrosis, pelvic abscess, intestinal obstruction

    Time frame: Till patient discharge

  3. Pathologic report outcome

    Lymph node harvest, radial and circumferential margin, complete total mesorectal excison

    Time frame: 7 days

07

Study locations

1 site
  • Oncology center of mansoura university
    Mansoura, Eldakahlia 35511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02455752
Lead sponsor
Mansoura University
Collaborators
West oncologic center, Nantes, France, Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Osama Mohammad Ali ElDamshety (Assisstant Lecturer of surgical oncology, Mansoura University) — Principal investigator
First posted
May 28, 2015
Start date
Mar 2015
Primary completion
Jun 2015
Completion
Jul 2015
Last update
Jul 17, 2015

Study contacts

Osama Eldamshety, PhD
principal investigator · 1-Assistant lecturer of surgical oncology, Mansoura university Egypt. 2-Research Fellow, Policlinico Umberto primo, LA SAPIENZA, Roma, Italy.
Frédéric Dumont, M.D.
principal investigator · 1- Department of Digestive Oncological surgery, West oncologic center, Nantes, France 2- Department of digestive Oncological surgery, Gustave Roussy Cancer Campus, Villejuif, France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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