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Completed

NCT Number: NCT02455752

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

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.

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Key information

Conditions

Total Mesorectal Excision Laparoscopic

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oncology center of mansoura university

Al Mansurah, Eldakahlia, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

LE-TME

Procedure

Retroperitoneal approach for total mesorectal excision

Primary outcomes

  1. Feasibility of the procedure

    Time frame: 1 day

    Feasibility of the TME by the retroperitoneal approach.

Secondary outcomes

  1. Intraoperative morbidity

    Time frame: 1 day

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

  2. Postoperative morbidity

    Time frame: Till patient discharge

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

  3. Pathologic report outcome

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris
  • West oncologic center, Nantes, France

Registry information

Acronym: LE-TME

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 28, 2015
Registry last updated
Jul 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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