Colorectal CancerNCT07208786
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
A study testing PEVT in people with Colorectal Cancer and Colorectal Surgery, run by Nanchong Central Hospital at 1 site in China.
Trial summary
Evaluate the safety and efficacy of postoperative Pre-emptive EVT (PEVT) in reducing the incidence of anastomotic leaks within 30 days after surgery in patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Surgery, Complications
- What is being tested?
- PEVT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pathologically diagnosed with colorectal cancer, planned for radical surgery (right hemicolectomy, left hemicolectomy, or anterior resection of the rectum, etc.).
- Age 18-85 years, American Society of Anesthesiologists (ASA) classification I-III.
- Anastomosis to be performed in a single stage (meeting anastomotic criteria).
- Patient or legal guardian is able to understand and sign the informed consent form and comply with follow-up.
Who cannot join
- Preexisting anastomotic leakage or severe intra-abdominal infection before surgery.
- Complicated by severe cardiovascular or cerebrovascular diseases (e.g., acute myocardial infarction, acute phase of cerebral infarction).
- Severe liver or kidney dysfunction (liver function Child-Pugh class C, creatinine clearance <30 ml/min).
- Coagulation disorders (platelets <50×10⁹/L, INR >1.5) or receiving anticoagulant therapy that cannot be adjusted.
- History of abdominal radiotherapy or multiple abdominal surgeries leading to severe intra-abdominal adhesions.
- Complicated by other malignant tumors and currently undergoing radiotherapy or chemotherapy.
- Psychiatric illness or cognitive impairment preventing compliance with the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanchong Central Hospital
Nanchong, Sichuan, 637000
Yunhong Tian, doctor, +8613508087719, drtianyunhong@126.com
About this study
Official title: Randomized Clinical Trial on Pre-emptive Endoscopic Vacuum Therapy Versus Conventional Management for the Prevention of Anastomotic Leakage After Colorectal Cancer Surgery
Evaluate the safety and efficacy of postoperative Pre-emptive EVT (PEVT) in reducing the incidence of anastomotic leaks within 30 days after surgery in patients with colorectal cancer. Compare the differences between the PEVT group and the control group in terms of operation time, length of hospital stay, and total medical costs. Analyze the incidence of other postoperative complications in the two groups, such as wound infection, abdominal abscess, and intestinal obstruction. Assess the impact of PEVT on postoperative recovery indicators, including time to first flatus, time to first defecation, and time to ambulation. Observe the occurrence of PEVT-related adverse events, such as device displacement, bleeding, and infection.
- Conditions
- Colorectal Cancer, Colorectal Surgery, Complications, Anastomotic Leakage, Endoscopic Vacuum Therapy
- Being tested
- PEVT
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEVTDevice
PEVT Procedures
After the anastomosis is completed and endoscopy confirms that the anastomotic site is intact and without bleeding, the following procedures are carried out immediately (usually within 30 minutes after the completion of the anastomosis):
- EVT device selection: Use an open-pore polyurethane sponge (OPPS) connected to a 16Fr nasogastric tube, with the sponge cut to a size of 2 cm × 3 cm.
- Placement method: Insert the sponge through the anus to the anastomotic site in the intestinal lumen, set the negative pressure to low intensity (-50 to -100 mmHg), and connect to an external negative pressure suction device for continuous suction.
| Study group | Role | What they receive |
|---|---|---|
| Pre-emptive Endoscopic Vacuum Therapy | Experimental | After the anastomosis is completed and confirmed by endoscopy to be intact and free of bleeding, immediately perform Pre-emptive Endoscopic Vacuum Therapy(PEVT). Receives: Device: PEVT |
| No Pre-emptive Endoscopic Vacuum Therapy | No intervention | After the anastomosis, only routine colonoscopy was performed without PEVT device, and other steps were consistent with the PEVT group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Anastomotic Leak within 30 days
Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery.
Measured: 30 days
Secondary outcomes (1)
Number of Participants with Postoperative Complications within 30 days
Count the number of participants who develop postoperative bleeding, anastomotic stenosis, and intra-abdominal infection within 30 days after colorectal cancer surgery.
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 posted6 Oct 2025
- Study start22 Sep 2025
- Primary completion10 Oct 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208786
- Sponsor's protocol ID
- 2025166
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on Pre-emptive Endoscopic Vacuum Therapy Versus Conventional Management for the Prevention of Anastomotic Leakage After Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07208786
- Acronym / sponsor ID
- 2025166
- Conditions
- Colorectal Cancer, Colorectal Surgery, Complications, Anastomotic Leakage, Endoscopic Vacuum Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 10 Oct 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Oct 2025 (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.
Evaluate the safety and efficacy of postoperative Pre-emptive EVT (PEVT) in reducing the incidence of anastomotic leaks within 30 days after surgery in patients with colorectal cancer. Compare the differences between the PEVT group and the control group in terms of operation time, length of hospital stay, and total medical costs. Analyze the incidence of other postoperative complications in the two groups, such as wound infection, abdominal abscess, and intestinal obstruction. Assess the impact of PEVT on postoperative recovery indicators, including time to first flatus, time to first defecation, and time to ambulation. Observe the occurrence of PEVT-related adverse events, such as device displacement, bleeding, and infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-emptive Endoscopic Vacuum Therapy | Experimental | Device: PEVTAfter the anastomosis is completed and confirmed by endoscopy to be intact and free of bleeding, immediately perform Pre-emptive Endoscopic Vacuum Therapy(PEVT). |
| No Pre-emptive Endoscopic Vacuum Therapy | No intervention | –After the anastomosis, only routine colonoscopy was performed without PEVT device, and other steps were consistent with the PEVT group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically diagnosed with colorectal cancer, planned for radical surgery (right hemicolectomy, left hemicolectomy, or anterior resection of the rectum, etc.).
- Age 18-85 years, American Society of Anesthesiologists (ASA) classification I-III.
- Anastomosis to be performed in a single stage (meeting anastomotic criteria).
- Patient or legal guardian is able to understand and sign the informed consent form and comply with follow-up.
Key exclusion criteria (7 listed)
- Preexisting anastomotic leakage or severe intra-abdominal infection before surgery.
- Complicated by severe cardiovascular or cerebrovascular diseases (e.g., acute myocardial infarction, acute phase of cerebral infarction).
- Severe liver or kidney dysfunction (liver function Child-Pugh class C, creatinine clearance <30 ml/min).
- Coagulation disorders (platelets <50×10⁹/L, INR >1.5) or receiving anticoagulant therapy that cannot be adjusted.
- History of abdominal radiotherapy or multiple abdominal surgeries leading to severe intra-abdominal adhesions.
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 |
|---|---|---|
| PEVTPEVT Procedures After the anastomosis is completed and endoscopy confirms that the anastomotic site is intact and without bleeding, the following procedures are carried out immediately (usually within 30 minutes after the completion of the anastomosis): 1. EVT device selection: Use an open-pore polyurethane sponge (OPPS) connected to a 16Fr nasogastric tube, with the sponge cut to a size of 2 cm × 3 cm. 2. Placement method: Insert the sponge through the anus to the anastomotic site in the intestinal lumen, set the negative pressure to low intensity (-50 to -100 mmHg), and connect to an external negative pressure suction device for continuous suction. | Device | Pre-emptive Endoscopic Vacuum Therapy |
Primary outcome
Number of Participants with Anastomotic Leak within 30 days
Time frame: 30 days
Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery.
1 secondary outcome
Number of Participants with Postoperative Complications within 30 days
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEVT in people with Colorectal Cancer and Colorectal Surgery, run by Nanchong Central Hospital 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunhong Tian Tian, doctor (+8613508087719, drtianyunhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Anastomotic Leak within 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.