RecruitingNot Applicable

Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)

China1,384 participantsStarted 2023-12-01

Plain-language summary

The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient age between 18-75 years.
. Colonic biopsy pathology confirms adenocarcinoma.
. At initial treatment, colonoscopy and imaging diagnose the tumor's lower edge as less than or equal to 7cm from the anus.
. At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3.
. At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery.
. At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three.
. Strong willingness for surgery and signed informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

3-year disease free survival rate

Timeframe: 3 years after surgery

Trial details

NCT IDNCT06146946

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Mingguang Zhang, Dr.

+8613261967603 zmgslimshady@163.com

View on ClinicalTrials.gov More Rectal Cancer trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient age between 18-75 years.
. Colonic biopsy pathology confirms adenocarcinoma.
. At initial treatment, colonoscopy and imaging diagnose the tumor's lower edge as less than or equal to 7cm from the anus.
. At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3.
. At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery.
. At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three.
. Strong willingness for surgery and signed informed consent.

Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria