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Trial Title:
Outcome of Laparoscopic Total Mesorectal Excision Versus Open Technique in Management of Rectal Carcimoma
NCT ID:
NCT05685680
Condition:
Rectal Carcinoma
Conditions: Official terms:
Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
total mesorectal excision in rectal carcinoma
Description:
total mesorectal excision laparoscopic versus open technique in management of rectal
carcinoma
Arm group label:
Group A laparoscopic group
Arm group label:
Group B
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. 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Gender:
All
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sohag University Hospital
Address:
City:
Sohag
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Magdy M Amin, professor
Start date:
December 20, 2022
Completion date:
December 20, 2023
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05685680