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Trial Title:
Multi-Technology Integrated Total Mesorectal Excision Versus Conventional Total Mesorectal Excision for the Treatment of Middle and Distal Rectal Cancer.
NCT ID:
NCT06613399
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
MTI-TME
anastomotic leakage
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
MTI-TME
Description:
Multi-Technology Tntegrated Total Mesorectal Excision，MTI-TME
Arm group label:
Multi-Technology Integrated Total Mesorectal Excision，MTI-TME
Intervention type:
Procedure
Intervention name:
C-TME
Description:
Conventional Total Mesorectal Excision，C-TME
Arm group label:
Conventional Total Mesorectal Excision，C-TME
Summary:
A multicenter, prospective, randomized, controlled clinical trial of multi-technology
integration total mesorectal excision (MTI-TME) versus conventional total mesorectal
excision (C-TME) for the treatment of middle and distal rectal cancer
Detailed description:
Currently, laparoscopic total mesorectal excision (TME) has become the standard procedure
for treating middle and distal rectal cancer. Anastomotic leakage has always been one of
the serious complications of TME surgery, and Anastomotic leakage not only increases the
hospital expenses, but also brings physical discomfort and psychological pain to the
patients. Furthermore, anastomotic leakage is associated with a heightened risk of
anastomotic stenosis, compromised bowel function, delayed initiation of postoperative
adjuvant therapy, increased local recurrence rates post-surgery, and diminished long-term
survival outcomes. A report from the Netherlands indicates that anastomotic leakage
serves as an independent prognostic factor for overall survival in patients diagnosed
with rectal cancer. Prior studies have documented the incidence of anastomotic leakage to
range between 3.6% and 21%, attributable to a confluence of various factors including
technical complications, oncological considerations, and the patient's overall health
status. Among these determinants, aspects such as blood supply adequacy, tension at the
site of anastomosis, tissue quality, and anatomical positioning of the rectum are widely
recognized as significant risk factors for developing anastomotic leaks.Currently,
several strategies are employed to mitigate the incidence of anastomotic leakage,
including preoperative proctocolectomy, anal decompression placement, vertical transverse
resection of the rectum, and anastomotic reinforcement techniques. In our clinical
practice, we have innovatively integrated multiple approaches: (1) preservation of the
left colic artery (LCA); (2) high-level resection of the inferior mesenteric vein (IMV);
(3) standardized mobilization of the splenic flexure along with left lateral colon; (4)
multi-plane dissection of mesorectal flaps; and (5) selective reinforcement at the
anastomosis. Our findings indicate that multi-technology integrated total mesorectal
excision (MTI-TME) significantly reduces both preventive stoma rates and incidences of
anastomotic leakage compared to conventional total mesorectal excision (C-TME), .
However, there remains a lack of robust evidence-based medicine supporting MTI-TME's
advantages in treating middle and distal rectal cancer; further research is urgently
needed to provide additional clinical evidence.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participants must be aged 18 to 75.
2. Histopathological examination of the preoperative biopsy confirms adenocarcinoma.
3. Preoperative MRI shows the tumor's lower margin is below the umbilical ligament.
4. High-resolution CT and MRI do not indicate suspicious distant metastasis.
5. Participants' general condition is acceptable, with an ASA score of ≤3 before
surgery.
6. Participants must sign an informed consent form.
Exclusion Criteria:
1. Developing other malignant tumors within 5 years;
2. Multiple primary colorectal tumors;
3. Pregnant or lactating women;
4. Patients with severe mental disorders;
5. Severe intestinal diseases;
6. Poor general condition and uncontrolled comorbidities;
7. Ineligible for laparoscopic surgery;
8. Participating in other clinical trials.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
January 1, 2025
Completion date:
December 31, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06613399
