Anastomotic LeakNCT06155175
Risk of NSAIDs on Anastomotic Leak for Rectal Surgery
An observational study of Anastomotic Leak and Anti-Inflammatory Agents, Non-Steroidal, run by Third Military Medical University at 1 site in China.
Trial summary
Conflicting reports of the association between early postoperative non-steroidal anti-inflammatory drugs (NSAIDs) administration and anastomotic leak (AL) after rectal surgery have continued. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak, Anti-Inflammatory Agents, Non-Steroidal
- What is being tested?
- NSAIDs
- How many people
- 1,969 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 25 Feb 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent elective rectal resection surgery
Who may be able to join
- Biopsy-proven adenocarcinoma of the rectum
- Age over 18 years old
- Patients underwent non-emergency minimally invasive surgery with a primary anastomosis
Who cannot join
- Incomplete medical records
- Patients with distant metastasis before surgery
- Patients with multiple primary colorectal carcinomas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Postoperative Non-steroidal Anti-inflammatory Drugs and Anastomotic Leakage for Rectal Cancer
Conflicting reports of the association between early postoperative non-steroidal anti-inflammatory drugs (NSAIDs) administration and anastomotic leak (AL) after rectal surgery have continued. The definition of AL and the exposure of NSAIDs differ from each other among studies, which may result in the different conclusions.
The aim of this retrospective study was to clarify the effect of NSAIDs on anastomotic leak from new angels.
Read the detailed description
Concerning about the side effects induced by opioids, nonsteroidal anti-inflammatory drugs (NSAIDs) have gained its popularity in ERAS protocols. NSAIDs competitively inhibits the activity of cyclooxygenases (COXs), which are involved in migration of epithelial cell and mucosal restitution, angiogenesis and collagen synthesis during healing. Conflicting reports of the association between early postoperative non-steroidal anti-inflammatory drugs (NSAIDs) administration and anastomotic leak (AL) after rectal surgery have continued.
Notably, the definition of AL and the exposure of NSAIDs (i.e. NSAIDs administration) differ from each other among the studies, which may result in the different conclusions. In concrete terms, the definition of NSAIDs administration timing varies from the first day to the first week after surgery, while the AL was also defined in multiple ways (timing varies from 14 to 90 days postoperatively, or only leaks with operative intervention included). Most previous studies suggested that early and late AL are different entities with different risk factors. These interesting evidences indicate reconsidering the effect of NSAIDs on AL is needed.
Hence, investigators defined the NSAIDs administration as at least once in the early postoperative period--the day of and the day after surgery (NSAID group), to avoid the inclusion of patients started on NSAIDs secondary to a complication. At the same time, investigators also classified AL into early AL (confirmed within 6 days) and late AL (over 6 days). Moreover, concerning the higher rate of AL in rectal surgery than colonic surgery and the trend of minimally invasive surgery, investigators performed the current study, aiming to clarify the association between early postoperative NSAIDs and anastomotic leak in rectal surgery.
- Being tested
- NSAIDs
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDsDrug
The exposure to NSAIDs: NSAIDs was used at least once within the first day after surgery
| Study group | Role | What they receive |
|---|---|---|
| NSAIDs | patients were treated with NSAIDs postoperatively Receives: Drug: NSAIDs | |
| No-NSAIDs | patients were not treated with NSAIDs postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative anastomotic leak
The primary outcome was anastomotic leak within 30 days after surgery. AL was defined as observing clinical signs of leak (such as high fever, abdominal pain, increasing of inflammatory factors in blood, purulent or fecal drainage from the drain, wound or vagina), and was confirmed by digital imaging or reoperation. Early AL was defined as being confirmed within 6 days postoperatively while late AL was defined as being confirmed after 6 days postoperatively
Measured: within 30 days
Secondary outcomes (1)
The incidence of postoperative compolications
Secondary outcomes include wound infection, anastomotic bleeding and obstruction.
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 May 2023
- Primary completion31 Dec 2023
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,969 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Tong, Third Military Medical University
- Investigators
- WeiDong Tong, MD, Study director, Department of General Surgery, Daping Hospital, Army Medical University, Chongqing 400042, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155175
- Sponsor's protocol ID
- 20230804
- Status last verified
- May 2025
- First submitted
- 24 Nov 2023
- Last updated
- 7 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Non-steroidal Anti-inflammatory Drugs and Anastomotic Leakage for Rectal Cancer
- ClinicalTrials.gov ID
- NCT06155175
- Acronym / sponsor ID
- 20230804
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,969 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 4 Dec 2023 (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.
Conflicting reports of the association between early postoperative non-steroidal anti-inflammatory drugs (NSAIDs) administration and anastomotic leak (AL) after rectal surgery have continued. The definition of AL and the exposure of NSAIDs differ from each other among studies, which may result in the different conclusions.
The aim of this retrospective study was to clarify the effect of NSAIDs on anastomotic leak from new angels.
Detailed description
Concerning about the side effects induced by opioids, nonsteroidal anti-inflammatory drugs (NSAIDs) have gained its popularity in ERAS protocols. NSAIDs competitively inhibits the activity of cyclooxygenases (COXs), which are involved in migration of epithelial cell and mucosal restitution, angiogenesis and collagen synthesis during healing. Conflicting reports of the association between early postoperative non-steroidal anti-inflammatory drugs (NSAIDs) administration and anastomotic leak (AL) after rectal surgery have continued.
Notably, the definition of AL and the exposure of NSAIDs (i.e. NSAIDs administration) differ from each other among the studies, which may result in the different conclusions. In concrete terms, the definition of NSAIDs administration timing varies from the first day to the first week after surgery, while the AL was also defined in multiple ways (timing varies from 14 to 90 days postoperatively, or only leaks with operative intervention included). Most previous studies suggested that early and late AL are different entities with different risk factors. These interesting evidences indicate reconsidering the effect of NSAIDs on AL is needed.
Hence, investigators defined the NSAIDs administration as at least once in the early postoperative period--the day of and the day after surgery (NSAID group), to avoid the inclusion of patients started on NSAIDs secondary to a complication. At the same time, investigators also classified AL into early AL (confirmed within 6 days) and late AL (over 6 days). Moreover, concerning the higher rate of AL in rectal surgery than colonic surgery and the trend of minimally invasive surgery, investigators performed the current study, aiming to clarify the association between early postoperative NSAIDs and anastomotic leak in rectal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAIDs | – | Drug: NSAIDspatients were treated with NSAIDs postoperatively |
| No-NSAIDs | – | –patients were not treated with NSAIDs postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent elective rectal resection surgery
Key inclusion criteria (3 listed)
- Biopsy-proven adenocarcinoma of the rectum
- Age over 18 years old
- Patients underwent non-emergency minimally invasive surgery with a primary anastomosis
Key exclusion criteria (3 listed)
- Incomplete medical records
- Patients with distant metastasis before surgery
- Patients with multiple primary colorectal carcinomas
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 |
|---|---|---|
| NSAIDsThe exposure to NSAIDs: NSAIDs was used at least once within the first day after surgery | Drug | NSAIDs |
Primary outcome
The incidence of postoperative anastomotic leak
Time frame: within 30 days
The primary outcome was anastomotic leak within 30 days after surgery. AL was defined as observing clinical signs of leak (such as high fever, abdominal pain, increasing of inflammatory factors in blood, purulent or fecal drainage from the drain, wound or vagina), and was confirmed by digital imaging or reoperation. Early AL was defined as being confirmed within 6 days postoperatively while late AL was defined as being confirmed after 6 days postoperatively
1 secondary outcome
The incidence of postoperative compolications
Time frame: within 30 days
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 7 May 2025.
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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.
WeiDong Tong, MD study director
Department of General Surgery, Daping Hospital, Army Medical University, Chongqing 400042, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak and Anti-Inflammatory Agents, Non-Steroidal, run by Third Military Medical University 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 3 inclusion and 3 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 7 May 2025. 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 incidence of postoperative anastomotic leak (time frame: within 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 7 May 2025.