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Simple surgical stitch may prevent dangerous bowel blockage after rectal cancer surgery

NCT ID NCT07432542

Disease control 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at whether closing the pelvic floor with stitches after removing rectal cancer can stop the bowel from getting blocked. About 516 people having keyhole surgery for mid-low rectal cancer will be randomly assigned to get the closure or not. The main goal is to see who gets a bowel blockage within 30 days after surgery, and also check recovery, complications, and quality of life.

What this could mean

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

Active substance
Pelvic floor peritoneum closure (a surgical procedure)
What this could lead to
If successful, this could become a standard step in rectal cancer surgery to prevent painful bowel blockages and speed up recovery.
What could go wrong
This is a mid-stage trial, so results may not apply to all patients. The procedure could also increase other complications like infection or leakage.

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 516 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: 18-75 years * Pathology: Histologically confirmed rectal adenocarcinoma * Tumor Location: Mid-low rectal cancer (inferior margin ≤10 cm from anal verge) * Surgical Procedure: Laparoscopic radical resection with sphincter preservation * Exclusion of Other Cancers: No concurrent or prior multiple primary malignancies * Organ Function: Adequate hepatic/renal/cardiopulmonary function * Informed Consent: Patient/legal guardian comprehends the study and provides written informed consent Exclusion Criteria: * Concurrent or prior history of malignant tumors. * Miles procedure or Hartmann's operation. * Intraoperative failure to open the peritoneal reflection. * Prior pelvic floor surgery. * Emergency surgery for bowel obstruction. * Severe hepatic/renal/cardiopulmonary dysfunction, coagulopathy, or underlying diseases contraindicating surgery. * History of severe psychiatric disorders. * Pregnancy or lactation. * Investigator-determined clinical/laboratory contraindications.

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Conditions

The condition(s) this trial relates to.

ileus intestinal obstruction rectal cancer rectal neoplasm

As listed by the trial registrant

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

Ileus Intestinal obstruction Middle and low rectal cancer Rectal cancer surgery

Contacts and locations

Locations

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

    Guangzhou, Guangdong, 518000, China

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