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

NCT06613399 | Not Yet Recruiting DMC

• 1 other identifier: PRSYM202409
• Study Type: interventional
• Target: 324
• Locations: 0 countries
• Sites: N/A

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

Conditions

Rectal Cancer

Keywords

MTI-TME; anastomotic leakage

Outcome Measures

Primary Outcomes (1)

• anastomotic leakage rate

  1 year

Secondary Outcomes (12)

• Operation time

  During surgery

• intraoperative blood loss

  During surgery

• 3-year overall suvival rate

  3 years

• local recurrance rate

  3 years

• 3-year disease-free survival rate

  3 years

Study Arms (2)

Multi-Technology Integrated Total Mesorectal Excision，MTI-TME

EXPERIMENTAL

Procedure: MTI-TME

Conventional Total Mesorectal Excision，C-TME

PLACEBO COMPARATOR

Procedure: C-TME

Interventions

MTI-TME PROCEDURE

Multi-Technology Tntegrated Total Mesorectal Excision，MTI-TME

Multi-Technology Integrated Total Mesorectal Excision，MTI-TME

C-TME PROCEDURE

Conventional Total Mesorectal Excision，C-TME

Conventional Total Mesorectal Excision，C-TME

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yueming Sun, MD

CONTACT

86-025-68306026; sunyueming@njmu.edu.cn

Yifei Feng, MD

CONTACT

86-025-68305386; fengyifei1982@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 26, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 26, 2024

Record last verified: 2024-09