NCT05502354

CRP-guided Transanal Drainage Removal After Rectal Surgery

A Single Arm Study to Investigate the Safety and Efficacy of C Reactive Protein (CRP) Guided Transanal Drainage Tube (TDT) Removal for Anastomotic Leak (AL) Prevention Following Laparoscopic Anterior Resection for Rectal Carcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Previously, TDT was removed at the surgeon's own discretion. In the present study, we design a single arm study to investigate the safety and efficacy of CRP-guided TDT removal for AL prevention following laparoscopic anterior resection for rectal carcinoma

Conditions

• Rectal Cancer
• Anastomotic Leak

Interventions

Type	Name	Description
DEVICE	removal of transanal drainage tube	removal of transanal drainage tube after laparoscopic anterior resection for rectal carcinoma according to postoperative CRP trajectory

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-12-31
• Completion: 2025-02-01
• First posted: 2022-08-16
• Last updated: 2023-11-21

Locations

1 site across 1 country: China