Recruiting nowNot phasedRandomised
What this trial is trying to do
The researchers are testing whether a standardized Precision Partial Intersphincteric Resection can remove the tumour while leaving more of the anal sphincter intact than a traditional intersphincteric resection. The trial will compare the procedures’ safety, cancer-control measures and effects on bowel function.
The hoped-for benefit is better postoperative anal function without compromising cancer treatment. The main measure is the Wexner score, a questionnaire-based measure of bowel-control problems; an improvement would mean fewer or less severe symptoms after surgery.
Worth knowing: The main outcome is anal function rather than survival, so the trial may not establish whether either operation helps people live longer.
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 | NCT07849023 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, open label |
| Taking part | 100 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | First Affiliated Hospital of Wenzhou Medical University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Precision Partial Intersphincteric Resection (PPISR)
- Procedure Traditional Intersphincteric Resection
What it is measuring
Postoperative anal function as assessed by Wexner Score
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 study is to establish a standardized operating procedure for Precision Partial Intersphincteric Resection (PPISR), and to evaluate its surgical safety, functional benefits, and oncological efficacy.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
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
- Patients aged 18-75 years old
- Pathology suggestive of moderately to highly differentiated rectal adenocarcinoma
- Tumor lower margin ≤ 5 cm from the anal verge
- Pre-operative tumor (T) staging of T1-T3 and T1-T2 below the level of the anal raphe muscle
- No distant metastasis such as lung, liver and other organs
Exclusion Criteria
- Preoperative patients with severe underlying diseases (such as severe liver and kidney function, cardiopulmonary function, coagulation dysfunction, etc.)
- Patients with malignant tumors in other parts of the body
- Patients who underwent emergency surgery due to acute perforation, obstruction, etc.
- Patients with tumor infiltration of peripheral organs during the operation, which required combined resection or palliative resection
- Patients who had a mid-opening laparoscopic operation for various reasons -during the operation
- Patients with poor anal function before operation, which is not suitable for anus preservation surgery.
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 1 site. 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 NCT07849023, registered by First Affiliated Hospital of Wenzhou Medical 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.