Recruiting nowNot phasedRandomised
What this trial is trying to do
The researchers are testing whether a two-stage Turnbull-Cutait operation, in which the colon is brought through the anus and joined to the anal canal after a delay, can be an alternative to low anterior resection with a temporary protective stoma for low rectal cancer. The trial will compare these operations after random assignment.
The idea is that the Turnbull-Cutait approach may reduce the chance of a permanent stoma while preserving acceptable bowel and anal function. The main test is 3-year stoma-free survival; the researchers will also compare complications, quality of life, anal function, disease-free survival and overall survival.
Worth knowing: The primary measure is remaining free of a stoma, not survival itself, and the operation’s safety and cancer outcomes are still being tested.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07369531 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, blinded |
| Taking part | 520 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | The First Hospital of Jilin University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Turnbull-Cutait anastomosis
- Procedure LAR
What it is measuring
3-year stoma-free survival postoperatively
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
The goal of this clinical trial is to explore the difference in 3-year stoma-free survival between the Turnbull-Cutait delayed coloanal anastomosis (TCA) surgery and the low anterior resection combined with protective stoma (LAR) surgery in patients with low rectal cancer, as well as the differences in anal function, surgical complications, and survival outcomes within 1 year after surgery. The main questions it aims to answer are:
1. Is TCA surgery superior to LAR surgery in improving the 3-year stoma-free survival of patients with low rectal cancer?
2. Are there differences in postoperative anal function (assessed by LARS score and Wexner score), quality of life (assessed by EORTC QLQ-CR29 questionnaire), surgical complications, pathological outcomes, and long-term survival (disease-free survival, time to recurrence, overall survival) between the two surgical methods? Researchers will compare the TCA group and the LAR group to see if TCA surgery can reduce the permanent stoma rate, improve postoperative anal function and quality of life, and ensure surgical safety and favorable tumor-related outcomes compared with LAR surgery.Participants will:
1. Be randomly assigned to either the TCA group or the LAR group in a 1:1 ratio.
2. Receive the corresponding surgical intervention.
3.Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Patients with rectal cancer aged 18-75 years confirmed by pathological biopsy as adenocarcinoma;
2. Preoperative abdominal contrast-enhanced CT and pulmonary CT (or PET-CT) showed no evidence of distant metastasis;
3. Preoperative rectal MRI evaluation demonstrated that the tumor was located within 5cm below the anal margin, above the intermuscular groove between the internal and external anal sphincters (anal white line) by 1 cm, and without invasion of the external anal sphincter;
4. For tumors located above the levator ani hiatus, MRI evaluation showed cT1-3, cN0-1, M0, MRF (-); for tumors located below the levator ani hiatus, MRI evaluation showed cT1-2, cN0-1, M0, MRF (-). For patients who received neoadjuvant therapy, tumors above the levator ani hiatus were downstaged to ycT3NxM0 or below, and tumors below the levator ani hiatus were downstaged to ycT2NxM0 or below;
5. Preoperative BMI < 28 kg/m²
6. Patients underwent radical laparoscopic/robot-assisted total mesorectal excision (TME) or transanal total mesorectal excision (TaTME).
Exclusion Criteria
1. Patients diagnosed with concurrent primary malignant tumors in any other organ or multiple distant colorectal cancers;
2. History of previous open surgery (non-minimally invasive procedures);
3.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 2 sites. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07369531, registered by The First Hospital of Jilin University on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.