Rectal CarcinomaNCT05685680
Outcome of Laparoscopic Total Mesorectal Excision Versus Open Technique in Management of Rectal Carcimoma
A study testing total mesorectal excision in rectal carcinoma in people with Rectal Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
Colorectal cancer is the second leading cause of death in the West, and rectal cancer accounts for about 25% of colon cancers Low anterior resection has been the mainstay of rectal cancer surgery in low rectal cancer since the 1970s. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rectal Carcinoma
- What is being tested?
- total mesorectal excision in rectal carcinoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2022to 20 Dec 2023
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients with pathologically confirmed rectal carcinoma involving middle or lower third rectum and operable by MRI and CT scan criteria.
- Both sexes will be included.
- Age: ranging from 20 to 70 years.
Who cannot join
- Patients with stage IV.
- Recurrent rectal cancers.
- Combined malignancy.
- Patients admitted due to emergency situations (acute large bowel obstruction, abdominal abscess, or rectal perforation and hemorrhage).
- Patients with contraindication for laparoscopic surgery.
- Unfit patients (ASA score > II).
Trial locations and contacts
1 site in 1 country.
omar A abd el-raheem, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, professor
About this study
Official title: Outcome of Laparoscopic Total Mesorectal Excision Versus Open Technique in Management of Rectal Carcinoma
Colorectal cancer is the second leading cause of death in the West, and rectal cancer accounts for about 25% of colon cancers
Low anterior resection has been the mainstay of rectal cancer surgery in low rectal cancer since the 1970s. Although the best efforts of experienced surgeons, The local recurrence rate is 3 to 33% in conventional surgery, while total mesorectal excision (TME) results indicate a recurrence rate of less than 10%
Read more
The evolution of the concept of TME which was first revealed by Heald.in 1982 made a major shift in the treatment strategies (Rodriguez-Luna et al,2015). The concept of TME was the most important event in surgery for rectal cancer in the last two decades, because even without a curative approach, the local recurrence decreased to 6 to 12%, and 5-year survival improved by 53-87% TME described clear definitions of distal resection margin (DRM), circumferential resection margin (CRM), and least number of harvested lymph nodes, so oncological outcomes improved, locoregional recurrence and survival rates also influenced .
Laparoscopic total mesorectal excision (LTME) may be associated with less blood loss, earlier recovery, and lower morbidity. Identification of the small nerves and vessels became easiear because of laparoscopic magnified view of pelvis and thus prevents these injuries (Sajid et al, 2019). Also, minimal surgical trauma will reduce the immunologic response and preserves postoperative immunologic defenses. This may lead to low rate of infections as well as low local recurrences and distant metastases in addition to, tissue handling with less manipulation, 'may reduces the spread of cancer cells
TME in obese males with low and anterior rectal tumors is technically challenging especially post neoadjuvant chemoradiotherapy due to distortion of the anatomical planes (Ng et al, 2014). In these patients, it is difficult to obtain a proper view of the dissection plane, in open technique which threatens the integrity of TME and carries the risk of positive margins, which is related to higher rates of local recurrence
LTME is a widely used approach for rectal cancers; although conversion rate varies from 1.2 to 17%, and it is higher if BMI is equal to or more than 30
- Conditions
- Rectal Carcinoma
- Being tested
- total mesorectal excision in rectal carcinoma
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total mesorectal excision in rectal carcinomaProcedure or surgery
total mesorectal excision laparoscopic versus open technique in management of rectal carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Group A laparoscopic group | Active comparator | group A laparoscopic surgery Receives: Procedure: total mesorectal excision in rectal carcinoma |
| Group B | Active comparator | Group B open surgery Receives: Procedure: total mesorectal excision in rectal carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison betewen laparoscopic and open teqnique in resection of rectal carcinoma and the involvement of the resection margin (R1), which is CRM involvement or DRM involvement.after resection.
R(resection margin of cancer of rectum) CRM circumferencial margin Or. DRM distal resection margin of cancer
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start20 Dec 2022
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Saleh Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685680
- Sponsor's protocol ID
- Soh-Med-22-12-17
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cecil TD, Sexton R, Moran BJ, Heald RJ. Total mesorectal excision results in low local recurrence rates in lymph node-positive rectal cancer. Dis Colon Rectum. 2004 Jul;47(7):1145-9; discussion 1149-50. doi: 10.1007/s10350-004-0086-6. Epub 2004 Jun 3.
PubMed 15164243Braga M, Frasson M, Vignali A, Zuliani W, Capretti G, Di Carlo V. Laparoscopic resection in rectal cancer patients: outcome and cost-benefit analysis. Dis Colon Rectum. 2007 Apr;50(4):464-71. doi: 10.1007/s10350-006-0798-5.
PubMed 17195085Hill GL, Rafique M. Extrafascial excision of the rectum for rectal cancer. Br J Surg. 1998 Jun;85(6):809-12. doi: 10.1046/j.1365-2168.1998.00735.x.
PubMed 9667714
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Laparoscopic Total Mesorectal Excision Versus Open Technique in Management of Rectal Carcinoma
- ClinicalTrials.gov ID
- NCT05685680
- Acronym / sponsor ID
- Soh-Med-22-12-17
- Conditions
- Rectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 17 Jan 2023 (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.
Colorectal cancer is the second leading cause of death in the West, and rectal cancer accounts for about 25% of colon cancers
Low anterior resection has been the mainstay of rectal cancer surgery in low rectal cancer since the 1970s. Although the best efforts of experienced surgeons, The local recurrence rate is 3 to 33% in conventional surgery, while total mesorectal excision (TME) results indicate a recurrence rate of less than 10%
The evolution of the concept of TME which was first revealed by Heald.in 1982 made a major shift in the treatment strategies (Rodriguez-Luna et al,2015). The concept of TME was the most important event in surgery for rectal cancer in the last two decades, because even without a curative approach, the local recurrence decreased to 6 to 12%, and 5-year survival improved by 53-87% TME described clear definitions of distal resection margin (DRM), circumferential resection margin (CRM), and least number of harvested lymph nodes, so oncological outcomes improved, locoregional recurrence and survival rates also influenced .
Laparoscopic total mesorectal excision (LTME) may be associated with less blood loss, earlier recovery, and lower morbidity. Identification of the small nerves and vessels became easiear because of laparoscopic magnified view of pelvis and thus prevents these injuries (Sajid et al, 2019). Also, minimal surgical trauma will reduce the immunologic response and preserves postoperative immunologic defenses. This may lead to low rate of infections as well as low local recurrences and distant metastases in addition to, tissue handling with less manipulation, 'may reduces the spread of cancer cells
TME in obese males with low and anterior rectal tumors is technically challenging especially post neoadjuvant chemoradiotherapy due to distortion of the anatomical planes (Ng et al, 2014). In these patients, it is difficult to obtain a proper view of the dissection plane, in open technique which threatens the integrity of TME and carries the risk of positive margins, which is related to higher rates of local recurrence
LTME is a widely used approach for rectal cancers; although conversion rate varies from 1.2 to 17%, and it is higher if BMI is equal to or more than 30
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A laparoscopic group | Active comparator | Procedure: total mesorectal excision in rectal carcinomagroup A laparoscopic surgery |
| Group B | Active comparator | Procedure: total mesorectal excision in rectal carcinomaGroup B open surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients with pathologically confirmed rectal carcinoma involving middle or lower third rectum and operable by MRI and CT scan criteria.
- Both sexes will be included.
- Age: ranging from 20 to 70 years.
Key exclusion criteria (6 listed)
- Patients with stage IV.
- Recurrent rectal cancers.
- Combined malignancy.
- Patients admitted due to emergency situations (acute large bowel obstruction, abdominal abscess, or rectal perforation and hemorrhage).
- Patients with contraindication for laparoscopic surgery.
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 mesorectal excision in rectal carcinomatotal mesorectal excision laparoscopic versus open technique in management of rectal carcinoma | Procedure or surgery | Group A laparoscopic group, Group B |
Primary outcome
Comparison betewen laparoscopic and open teqnique in resection of rectal carcinoma and the involvement of the resection margin (R1), which is CRM involvement or DRM involvement.after resection.
Time frame: 1year
R(resection margin of cancer of rectum) CRM circumferencial margin Or. DRM distal resection margin of cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Background: PubMed 15164243Cecil TD, Sexton R, Moran BJ, Heald RJ. Total mesorectal excision results in low local recurrence rates in lymph node-positive rectal cancer. Dis Colon Rectum. 2004 Jul;47(7):1145-9; discussion 1149-50. doi: 10.1007/s10350-004-0086-6. Epub 2004 Jun 3.
- Background: PubMed 17195085Braga M, Frasson M, Vignali A, Zuliani W, Capretti G, Di Carlo V. Laparoscopic resection in rectal cancer patients: outcome and cost-benefit analysis. Dis Colon Rectum. 2007 Apr;50(4):464-71. doi: 10.1007/s10350-006-0798-5.
- Background: PubMed 9667714Hill GL, Rafique M. Extrafascial excision of the rectum for rectal cancer. Br J Surg. 1998 Jun;85(6):809-12. doi: 10.1046/j.1365-2168.1998.00735.x.
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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.
omar A abd el-raheem, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total mesorectal excision in rectal carcinoma in people with Rectal Carcinoma, run by Sohag 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 3 inclusion and 6 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 17 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact osama s saleh, assistant lecture (01119966457, usama.mohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison betewen laparoscopic and open teqnique in resection of rectal carcinoma and the involvement of the resection margin (R1), which is CRM involvement or DRM involvement.after resection. (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05685680, which also lists 3 linked publications.
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 Jan 2023.