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NCT Number: NCT06155175

Risk of NSAIDs on Anastomotic Leak for Rectal Surgery

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.

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Key information

Conditions

Anastomotic Leak Anti-Inflammatory Agents, Non-Steroidal Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Army Medical Center

Chongqing, None Selected, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy-proven adenocarcinoma of the rectum
  • Age over 18 years old
  • Patients underwent non-emergency minimally invasive surgery with a primary anastomosis

Exclusion criteria

  • Incomplete medical records
  • Patients with distant metastasis before surgery
  • Patients with multiple primary colorectal carcinomas

Treatment and study plan

NSAIDs

Drug

The exposure to NSAIDs: NSAIDs was used at least once within the first day after surgery

Primary outcomes

  1. 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

Secondary outcomes

  1. The incidence of postoperative compolications

    Time frame: within 30 days

    Secondary outcomes include wound infection, anastomotic bleeding and obstruction.

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

Early Postoperative Non-steroidal Anti-inflammatory Drugs and Anastomotic Leakage for Rectal Cancer

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 4, 2023
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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