Total Mesorectal ExcisionLE-TMENCT02455752
Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.
A study testing LE-TME in people with Total Mesorectal Excision and Laparoscopic, run by Mansoura University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Mesorectal Excision, Laparoscopic
- What is being tested?
- LE-TME
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (Rectum, Anal or sigmoid) Malignancy requiring mesorectal excision and Fit for laparoscopic surgery
Who cannot join
- contraindication to laparoscopic surgery-unwilling to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oncology center of mansoura university
Al Mansurah, Eldakahlia, 35511
About this study
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.
- Conditions
- Total Mesorectal Excision, Laparoscopic
- Being tested
- LE-TME
- Keywords
- LE-TME, Laparoscopic rectal resection, Retroperitoneal resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LE-TMEProcedure or surgery
Retroperitoneal approach for total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| Reroperitoneal Group | Active comparator | LE-TME Receives: Procedure: LE-TME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the procedure
Feasibility of the TME by the retroperitoneal approach.
Measured: 1 day
Secondary outcomes (3)
Intraoperative morbidity
Intraoperative morbidity including Urteric injury, Vascular injuries, hypogastric nerve injury, intestinal loop injury.
Measured: 1 day
Postoperative morbidity
Postoperative haematoma, colonic leak and/or necrosis, pelvic abscess, intestinal obstruction
Measured: Till patient discharge
Pathologic report outcome
Lymph node harvest, radial and circumferential margin, complete total mesorectal excison
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Mesorectal ExcisionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- West oncologic center, Nantes, France, Gustave Roussy, Cancer Campus, Grand Paris
- Responsible party
- Principal investigator, Osama Mohammad Ali ElDamshety, Mansoura University
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455752
- Sponsor's protocol ID
- RTME-200315
- Acronym
- LE-TME
- Status last verified
- Jul 2015
- First submitted
- 26 May 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.
- ClinicalTrials.gov ID
- NCT02455752
- Acronym / sponsor ID
- LE-TME / RTME-200315
- Conditions
- Total Mesorectal Excision, Laparoscopic
- Keywords
- LE-TME, Laparoscopic rectal resection, Retroperitoneal resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- West oncologic center, Nantes, France, Gustave Roussy, Cancer Campus, Grand Paris
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reroperitoneal Group | Active comparator | Procedure: LE-TMELE-TME |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (Rectum, Anal or sigmoid) Malignancy requiring mesorectal excision and Fit for laparoscopic surgery
Key exclusion criteria (1 listed)
- contraindication to laparoscopic surgery-unwilling to participate in the clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LE-TMERetroperitoneal approach for total mesorectal excision | Procedure or surgery | Reroperitoneal Group |
Primary outcome
Feasibility of the procedure
Time frame: 1 day
Feasibility of the TME by the retroperitoneal approach.
3 secondary outcomes
Intraoperative morbidity
Time frame: 1 day
Postoperative morbidity
Time frame: Till patient discharge
Pathologic report outcome
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LE-TME in people with Total Mesorectal Excision and Laparoscopic, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the procedure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.