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A multicenter prospective randomized controlled study on the improvement of LARS for rectal cancer by a modified iTME procedure with visualization and preservation of the left colic artery plexus

A multicenter prospective randomized controlled study on the improvement of LARS for rectal cancer by a modified iTME procedure with visualization and preservation of the left colic artery plexus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128840
Enrollment
Unknown
Registered
2026-07-27
Start date
2026-08-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Control group:Adopting conventional iTME surgery
Experimental group:Adopting a modified iTME procedure that preserves the left colic artery's paraneural plexus through visualization

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75, of either gender, with a physical fitness status ECOG score of 0-1, and ASA class 1-3; 2. Histopathological examination confirmed rectal adenocarcinoma without distant metastasis; 3. The tumor is located 5-15cm from the anal verge, and laparoscopic iTME anal-preserving surgery is planned, with an expected R0 resection; 4. The anal sphincter function was normal before surgery, and there were no urinary and reproductive system diseases such as urinary dysfunction and erectile dysfunction; 5. Volunteer to join this study, be able to understand the research content and sign a written informed consent form, have good compliance, and be able to complete the full 12-month follow-up.

Exclusion criteria

Exclusion criteria: 1. People who have a history of colorectal surgery, pelvic radiation/surgery, or received neoadjuvant radiotherapy before surgery; 2. Those with severe heart, lung, liver, or kidney problems who can’t handle surgery; 3. People with other cancers, or with mental illnesses or cognitive issues that prevent them from cooperating with the study and follow-ups; 4. Those who, for tumor location, invasiveness, or other reasons, will eventually need a permanent stoma; 5. Other situations where the researcher thinks participation in the study isn’t suitable (like poor compliance or refusal to sign the consent form).

Design outcomes

Primary

MeasureTime frame
Incidence of LARS;Overall Survival Rate;

Secondary

MeasureTime frame
LARS score and incidence rate, Wexner fecal incontinence score, surgery-related indicators, intestinal function recovery indicators, postoperative complication incidence rate, EORTC QLQ-C30 quality of;

Countries

China

Contacts

Public ContactWei Hongbo

The Third Affiliated Hospital of Sun Yat-sen University

weihb@mail.sysu.edu.cn+86 20 8525 2157

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026