Cancer ColonNCT04079946
The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment
A study testing Total Mesocolic Excision with Central Vessel Ligation and conventional surgery of cancer colon in people with Cancer Colon, run by Assiut University.
Trial summary
Cancer Colon is one of the major public health problems worldwide. Complete eradication of the tumor with no recurrence or residual masses is a challenge which faces all the surgeons and medical staff all over the world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Colon
- What is being tested?
- Total Mesocolic Excision with Central Vessel Ligation and conventional surgery of cancer colon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Adult male and female Age of or above 18 years.
- Tumor localization at the caecum, ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid on preoperative endoscopy and radiographic imaging [barium enema or computed tomography (CT)]
- No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease
- Written informed consent
Who cannot join
- • Contraindications to major surgery and American Society of Anaesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment.
- Infectious disease requiring treatment.
- Pregnant women
- Use of systemic steroids.
- Severe pulmonary emphysema or pulmonary fibrosis
Trial locations and contacts
No sites are listed yet.
About this study
Cancer Colon is one of the major public health problems worldwide. Complete eradication of the tumor with no recurrence or residual masses is a challenge which faces all the surgeons and medical staff all over the world. A lot of techniques were used to ensure 100 % eradication of the tumor and to cure the patients from cancer. Total Mesocolic Excision with Central Vessel Ligation is one of the recent techniques used for colon cancer surgeries. Here in the research the investigators answer the question of how this technique is superior and more beneficial in complete eradication of the tumor than the conventional surgery for colon cancer
- Conditions
- Cancer Colon
- Being tested
- Total Mesocolic Excision with Central Vessel Ligation, conventional surgery of cancer colon
- Keywords
- cancer colon
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Mesocolic Excision with Central Vessel LigationProcedure or surgery
sharp dissection of the anatomical layers and the dissection of the visceral plane from the parietal one . In addition a central division of the feeding arteries at their origins is performed at the level of superior mesenteric artery for tumors of the right colon and at the level of inferior mesenteric artery or the aorta for tumors of the left colon .this allows for removal of the maximum number of lymph nodes possible.
conventional surgery of cancer colonProcedure or surgery
removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon
| Study group | Role | What they receive |
|---|---|---|
| patients for whom Complete mesocolic excision will be done | Active comparator | Not described Receives: Procedure: Total Mesocolic Excision with Central Vessel Ligation |
| patients had conventional surgery before | Active comparator | Not described Receives: Procedure: conventional surgery of cancer colon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph nodes harvest
Number of retrieved lymph nodes can be extracted by this technique
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColonStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Essam Hassan Farghly, Assiut University
- Investigators
- Mostafa A. Hassanein, professor, Study chair, Assiut UniversityMohamed B. Kotb, profeesor, Study director, Assiut UniversityMahmoud T. Ahmed, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079946
- Sponsor's protocol ID
- AssiutU93
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment
- ClinicalTrials.gov ID
- NCT04079946
- Acronym / sponsor ID
- AssiutU93
- Conditions
- Cancer Colon
- Keywords
- cancer colon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 6 Sep 2019 (actual)
- 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.
Cancer Colon is one of the major public health problems worldwide. Complete eradication of the tumor with no recurrence or residual masses is a challenge which faces all the surgeons and medical staff all over the world. A lot of techniques were used to ensure 100 % eradication of the tumor and to cure the patients from cancer. Total Mesocolic Excision with Central Vessel Ligation is one of the recent techniques used for colon cancer surgeries. Here in the research the investigators answer the question of how this technique is superior and more beneficial in complete eradication of the tumor than the conventional surgery for colon cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients for whom Complete mesocolic excision will be done | Active comparator | Procedure: Total Mesocolic Excision with Central Vessel Ligation |
| patients had conventional surgery before | Active comparator | Procedure: conventional surgery of cancer colon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Adult male and female Age of or above 18 years.
Key exclusion criteria (5 listed)
- • Contraindications to major surgery and American Society of Anaesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment.
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 |
|---|---|---|
| Total Mesocolic Excision with Central Vessel Ligationsharp dissection of the anatomical layers and the dissection of the visceral plane from the parietal one . In addition a central division of the feeding arteries at their origins is performed at the level of superior mesenteric artery for tumors of the right colon and at the level of inferior mesenteric artery or the aorta for tumors of the left colon .this allows for removal of the maximum number of lymph nodes possible. | Procedure or surgery | patients for whom Complete mesocolic excision will be done |
| conventional surgery of cancer colonremoval of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon | Procedure or surgery | patients had conventional surgery before |
Primary outcome
Lymph nodes harvest
Time frame: Two years
Number of retrieved lymph nodes can be extracted by this technique
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: Yes
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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.
Mostafa A. Hassanein, professor study chair
Assiut University
Mohamed B. Kotb, profeesor study director
Assiut University
Mahmoud T. Ahmed, lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Total Mesocolic Excision with Central Vessel Ligation and conventional surgery of cancer colon in people with Cancer Colon, run by Assiut University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr E. Hassan, resident Doctor (01004664295, amrelfayed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph nodes harvest (time frame: Two years). 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 6 Sep 2019.