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

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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: MTI-TME; Procedure: C-TME

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.

• Study Type: Interventional
• Enrollment (Estimated): 324
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueming Sun, MD; Phone Number: 86-025-68306026; Email: sunyueming@njmu.edu.cn
• Study Contact Backup: Name: Yifei Feng, MD; Phone Number: 86-025-68305386; Email: fengyifei1982@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-Technology Integrated Total Mesorectal Excision，MTI-TME	Procedure: MTI-TME; Multi-Technology Tntegrated Total Mesorectal Excision，MTI-TME
Placebo Comparator: Conventional Total Mesorectal Excision，C-TME	Procedure: C-TME; Conventional Total Mesorectal Excision，C-TME

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
anastomotic leakage rate	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
3-year mortality rate		3 years
postoperative quality of life	Postoperative quality of life will be evaluated by EORTC QLQ C30 Questionnaire	3 years
intestinal exhaust time		1 year
postoperative pain	Postoperative pain will be assessed by numerical rating scale (NES).	1 year
colostomy rate		1 year
hospital stay		1 year
hospital cost		1 year

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: anastomotic leakage; MTI-TME
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: PRSYM202409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No