Rectal CancerNCT04999007
Artificial Intelligence Assists Surgeons' Decision Making
A study testing Artificial intelligence algorithm in people with Rectal Cancer, run by Jichao Qin at 1 site in China.
Trial summary
This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Artificial intelligence algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 872 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2021to 17 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged older than 18 years and younger than 85 years.
- Primary rectal adenocarcinoma confirmed by preoperative pathology result.
- Expected curative resection via total mesorectal excision procedure.
- American Society of Anesthesiologists (ASA) class I, II, or III.
- Written informed consent.
Who cannot join
- Pregnant or breastfeeding women.
- Severe mental disorder or language communication disorder.
- Hartmann surgery or colostomy is performed intraoperatively.
- Interrupted of surgery for more than 30 minutes due to any cause.
- Malignant tumors with other organs
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: Artificial Intelligence-assisted Decision Making for Temporary Ileostomy: A Prospective Randomized Controlled Trail.
This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.
Read the detailed description
Anastomotic leakage is a serious and life-threatening complication after anterior resection in patients with rectal cancer, and temporary ileostomy was introduced to reduce the serious consequences due to anastomotic leakage. However, whether a temporary ileostomy is applied in the surgery depends on the surgeon's experience, and there are no clinical guidelines to follow. Recently, artificial intelligence has widely been applied in medical field and produced some exciting results, and we have developed a high-performance artificial intelligence model based on 2369 rectal cancer patients, which showed good discrimination of anastomotic leakage and may reduce the temporary ileostomy rate. Hence, this randomized controlled trail will evaluate the artificial intelligence model for guiding surgical decision-making of performing a temporary ileostomy in patients with rectal cancer who receive anterior resection.
- Conditions
- Rectal Cancer
- Being tested
- Artificial intelligence algorithm
- Keywords
- artificial intelligence,, rectal cancer, temporary ileostomy, anastomotic leakage
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence algorithmOther
Temporary ileostomy will be performed in the patients with high-risk of anastomotic leakage and not performed in the patients with low-risk of anastomotic leakage.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Whether the patients in the control arm will receive a temporary ileostomy depends on surgeons' experience. |
| Intervention | Experimental | Whether the patients in the intervention arm will receive a temporary ileostomy depends on the risk of anastomotic leakage calculated by the artificial intelligence algorithm. Receives: Other: Artificial intelligence algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of temporary ileostomy.
Measured: Intraoperative period
The morbidity of anastomotic leakage.
The diagnosis of anastomotic leakage is determined when the passage of fecal material from pelvic drainage tube or the water-soluble contrast agent enema and extra-rectal imaging. Alternatively, anastomotic leakage can be diagnosed when the integrity of the anastomosis is interrupted or the appearance of pelvic abscess next to the anastomosis by computerized tomography (CT) examination or secondary surgical exploration.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start2 Sep 2021
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 872 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jichao Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jichao Qin, Tongji Hospital
- Investigators
- Jichao Qin, MD, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999007
- Sponsor's protocol ID
- TJ-IRB20210643
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shao S, Li Y, Li J, Liu L, Zeng Y, Song C, Huang W, Mu L, Qin J. Machine learning model-guided selective use of temporary diverting ileostomy in rectal cancer surgery: a randomized controlled trial. Nat Commun. 2026 May 25;17(1):6802. doi: 10.1038/s41467-026-73565-4.
PubMed 42185305
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-assisted Decision Making for Temporary Ileostomy: A Prospective Randomized Controlled Trail.
- ClinicalTrials.gov ID
- NCT04999007
- Acronym / sponsor ID
- TJ-IRB20210643
- Conditions
- Rectal Cancer
- Keywords
- artificial intelligence,, rectal cancer, temporary ileostomy, anastomotic leakage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 872 participants (actual)
- Lead sponsor
- Jichao QinUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.
Detailed description
Anastomotic leakage is a serious and life-threatening complication after anterior resection in patients with rectal cancer, and temporary ileostomy was introduced to reduce the serious consequences due to anastomotic leakage. However, whether a temporary ileostomy is applied in the surgery depends on the surgeon's experience, and there are no clinical guidelines to follow. Recently, artificial intelligence has widely been applied in medical field and produced some exciting results, and we have developed a high-performance artificial intelligence model based on 2369 rectal cancer patients, which showed good discrimination of anastomotic leakage and may reduce the temporary ileostomy rate. Hence, this randomized controlled trail will evaluate the artificial intelligence model for guiding surgical decision-making of performing a temporary ileostomy in patients with rectal cancer who receive anterior resection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Whether the patients in the control arm will receive a temporary ileostomy depends on surgeons' experience. |
| Intervention | Experimental | Other: Artificial intelligence algorithmWhether the patients in the intervention arm will receive a temporary ileostomy depends on the risk of anastomotic leakage calculated by the artificial intelligence algorithm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged older than 18 years and younger than 85 years.
- Primary rectal adenocarcinoma confirmed by preoperative pathology result.
- Expected curative resection via total mesorectal excision procedure.
- American Society of Anesthesiologists (ASA) class I, II, or III.
- Written informed consent.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women.
- Severe mental disorder or language communication disorder.
- Hartmann surgery or colostomy is performed intraoperatively.
- Interrupted of surgery for more than 30 minutes due to any cause.
- Malignant tumors with other organs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial intelligence algorithmTemporary ileostomy will be performed in the patients with high-risk of anastomotic leakage and not performed in the patients with low-risk of anastomotic leakage. | Other | Intervention |
Primary outcome
The rate of temporary ileostomy.
Time frame: Intraoperative period
The morbidity of anastomotic leakage.
Time frame: 30 days
The diagnosis of anastomotic leakage is determined when the passage of fecal material from pelvic drainage tube or the water-soluble contrast agent enema and extra-rectal imaging. Alternatively, anastomotic leakage can be diagnosed when the integrity of the anastomosis is interrupted or the appearance of pelvic abscess next to the anastomosis by computerized tomography (CT) examination or secondary surgical exploration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 42185305Shao S, Li Y, Li J, Liu L, Zeng Y, Song C, Huang W, Mu L, Qin J. Machine learning model-guided selective use of temporary diverting ileostomy in rectal cancer surgery: a randomized controlled trial. Nat Commun. 2026 May 25;17(1):6802. doi: 10.1038/s41467-026-73565-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jichao Qin, MD principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence algorithm in people with Rectal Cancer, run by Jichao Qin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of temporary ileostomy. (time frame: Intraoperative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 3 Nov 2026.