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Simple wash during surgery may stop rectal cancer return

NCT ID NCT07512232

Prevention Sponsor: 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether rinsing the rectal cavity with a saltwater or iodine solution during laparoscopic surgery can prevent local recurrence of mid-to-low rectal cancer. About 1,600 patients will be randomly assigned to receive the wash or not, and they will be followed for five years. The goal is to see if this simple step reduces the chance of cancer growing back near the surgery site.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rectal irrigation with normal saline or povidone-iodine
What this could lead to
If it works, this simple procedure could become a standard step during rectal cancer surgery to lower the chance of cancer returning.
What could go wrong
This is a large trial, but the procedure is new for this purpose and may not reduce recurrence. There is also a small risk of infection or irritation from the wash.

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 1,598 people

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

Started

Jun 2025

Expected to finish

May 2028

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: * Age between 18 and 75 years old. * Pathologically confirmed rectal adenocarcinoma. * Mid-to-low rectal cancer with the tumor lower margin located ≤10 cm from the anal verge. * Underwent laparoscopic radical resection for rectal cancer with sphincter preservation. * Without concomitant multiple primary malignancies. * Adequate organ function. * Patients or their family members were able to understand the study protocol, willing to participate in this study, and provided written informed consent. Exclusion Criteria: * Concomitant other malignancies or a history of prior malignancies. * Abdominal perineal resection (Miles' operation) or Hartmann's procedure. * Failure to open the peritoneal reflection during surgery. * History of previous pelvic floor surgery. * Emergency surgery due to bowel obstruction. * Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction, or other severe comorbidities that render the patient unable to tolerate the procedure. * History of severe psychiatric disorders. * Pregnant or lactating women. * Any other clinical or laboratory conditions considered unsuitable for participation in the trial by the investigators.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Middle and low rectal cancer Rectal cancer surgery

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

  • Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 518000, China

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