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NCT Number: NCT06613399

Multi-Technology Integrated Total Mesorectal Excision Versus Conventional Total Mesorectal Excision for the Treatment of Middle and Distal Rectal Cancer.

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be aged 18 to 75.
  • Histopathological examination of the preoperative biopsy confirms adenocarcinoma.
  • Preoperative MRI shows the tumor's lower margin is below the umbilical ligament.
  • High-resolution CT and MRI do not indicate suspicious distant metastasis.
  • Participants' general condition is acceptable, with an ASA score of ≤3 before surgery.
  • Participants must sign an informed consent form.

Exclusion criteria

  • Developing other malignant tumors within 5 years;
  • Multiple primary colorectal tumors;
  • Pregnant or lactating women;
  • Patients with severe mental disorders;
  • Severe intestinal diseases;
  • Poor general condition and uncontrolled comorbidities;
  • Ineligible for laparoscopic surgery;
  • Participating in other clinical trials.

Treatment and study plan

MTI-TME

Procedure

Multi-Technology Tntegrated Total Mesorectal Excision,MTI-TME

C-TME

Procedure

Conventional Total Mesorectal Excision,C-TME

Primary outcomes

  1. anastomotic leakage rate

    Time frame: 1 year

Secondary outcomes

  1. Operation time

    Time frame: During surgery

  2. intraoperative blood loss

    Time frame: During surgery

  3. 3-year overall suvival rate

    Time frame: 3 years

  4. local recurrance rate

    Time frame: 3 years

  5. 3-year disease-free survival rate

    Time frame: 3 years

  6. 3-year mortality rate

    Time frame: 3 years

  7. postoperative quality of life

    Time frame: 3 years

    Postoperative quality of life will be evaluated by EORTC QLQ C30 Questionnaire

  8. intestinal exhaust time

    Time frame: 1 year

  9. postoperative pain

    Time frame: 1 year

    Postoperative pain will be assessed by numerical rating scale (NES).

  10. colostomy rate

    Time frame: 1 year

  11. hospital stay

    Time frame: 1 year

  12. hospital cost

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Yifei Feng, MD

CONTACT

[email protected]

86-025-68305386

Yueming Sun, MD

CONTACT

[email protected]

86-025-68306026

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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