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Which surgery saves the bowel best? new trial for rectal cancer patients

NCT ID NCT05943444

Symptom relief Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two surgical methods (Parks and Bacon) for ultra-low rectal cancer to see which one leads to better bowel function and quality of life a year after surgery. About 256 adults with rectal cancer will take part. The goal is to help doctors choose the best technique to reduce bowel problems after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 256 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men or women, aged between 18 and 75 years; 2. Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging; 3. No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation; 4. Suitable for anal preservation surgery discussed by MDT; 5. Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia; 6. R0 resection is expected technically; 7. Provision of written informed consent. Exclusion Criteria: 1. Previous history of malignant colorectal tumors; 2. Complications such as obstruction and gastrointestinal bleeding that need an emergency operation; 3. Unachievable R0 resection due to invasion of adjacent organs by primary tumor; 4. Multiple primary tumors; 5. History of other malignancy; 6. Participation in other clinical trials within the previous 4 weeks of enrollment; 7. ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2; 8. Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases; 9. History of serious mental disorders; 10. Women in pregnancy or lactation period; 11. Uncontrolled infection before operation; 12. Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak Low Anterior Resection Syndrome rectal cancer rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anastomotic leak Low anterior resection syndrome Quality of life Rectal neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Sixth Affiliated Hospital, Sun Yatsen University

    RECRUITING

    Guangzhou, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.