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Blood test and CT combo may spare rectal cancer patients a second surgery

NCT ID NCT07722533

Diagnosis Sponsor: Alexandria University Source: ClinicalTrials.gov ↗

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests whether a combination of serial C-reactive protein blood tests and targeted CT scans can safely identify which rectal cancer patients can skip a temporary ileostomy after laparoscopic low anterior resection. Anastomotic leakage is a serious complication, and a protective ileostomy reduces its impact but comes with its own risks. The trial will follow 60 adults undergoing elective surgery, measuring CRP daily and performing CT when criteria are met, to see if the surveillance pathway can avoid unnecessary ileostomies without increasing dangerous leaks.

What this could mean

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

Active substance
Serial C-reactive protein-guided computed tomography surveillance and selective omission of defunctioning ileostomy
What this could lead to
If successful, this approach could help many rectal cancer patients avoid a temporary ileostomy and its complications after surgery.
What could go wrong
This is a small, early-stage study. The surveillance pathway may not catch all leaks, and some patients might still need an ileostomy.

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

200 people

The number who actually took part.

Started

Jan 2023

Finished

Jun 2026

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 years and older

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: * Adults with primary resectable stage II or III middle- or lower-third rectal adenocarcinoma planned for laparoscopic low anterior resection with total mesorectal excision * completion of long-course neoadjuvant chemoradiotherapy * negative intraoperative air-leak test after anastomosis. Exclusion criteria: * Stage I disease * obstructed or perforated tumor * metastatic or recurrent disease; * synchronous colonic resection * total neoadjuvant therapy * positive intraoperative air-leak test.

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak rectal cancer rectum adenocarcinoma

As listed by the trial registrant

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

Anastomotic leakage Low anterior resection Rectal cancer patients

Contacts and locations

Locations

  • Alexandria main university hospital

    Alexandria, Please Select, 21111, Egypt

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