Risk of NSAIDs on Anastomotic Leak for Rectal Surgery

NCT06155175 | Completed

• 1 other identifier: 20230804
• Study Type: observational
• Target: 1,969
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anastomotic Leak; Anti-Inflammatory Agents, Non-Steroidal

Outcome Measures

Primary Outcomes (1)

• 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

  within 30 days

Secondary Outcomes (1)

• The incidence of postoperative compolications

  within 30 days

Study Arms (2)

NSAIDs

patients were treated with NSAIDs postoperatively

Drug: NSAIDs

No-NSAIDs

patients were not treated with NSAIDs postoperatively

Interventions

NSAIDs DRUG

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

NSAIDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who underwent elective rectal resection surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Army Medical Center

Chongqing, None Selected, China

Location

MeSH Terms

Conditions

Anastomotic Leak

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• WeiDong Tong, MD

  Department of General Surgery, Daping Hospital, Army Medical University, Chongqing 400042, China

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 25, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CN (1)