Clinical trial NCT06613399: Multi-Technology Integrated Total Mesorectal Excision Versus Conventional Total Mesorectal Excision for the Treatment of Middle and Distal Rectal Cancer.
Official title: A Randomized Controlled Study 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: MTI-TME
anastomotic leakage
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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\&#39;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\&#39;s advantages in treating middle and distal rectal cancer; further research is urgently needed to provide additional clinical evidence.

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\&#39;s lower margin is below the umbilical ligament.
4. High-resolution CT and MRI do not indicate suspicious distant metastasis.
5. Participants\&#39; 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.

Primary outcomes:
measure: anastomotic leakage rate
timeFrame: 1 year
Secondary outcomes:
measure: Operation time
timeFrame: During surgery
measure: intraoperative blood loss
timeFrame: During surgery
measure: 3-year overall suvival rate
timeFrame: 3 years
measure: local recurrance rate
timeFrame: 3 years
measure: 3-year disease-free survival rate
timeFrame: 3 years
measure: 3-year mortality rate
timeFrame: 3 years
measure: postoperative quality of life
timeFrame: 3 years
measure: intestinal exhaust time
timeFrame: 1 year
measure: postoperative pain
timeFrame: 1 year
measure: colostomy rate
timeFrame: 1 year
measure: hospital stay
timeFrame: 1 year
measure: hospital cost
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: