CRP-guided Transanal Drainage Removal After Rectal Surgery

Not Applicable

Recruiting

• Conditions: Rectal Cancer; Anastomotic Leak
• Interventions: Device: removal of transanal drainage tube

• Registration Number: NCT05502354
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-16
• Study Start: 2023-04-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• age from 18 to 75 years old
• male and female
• primary rectal adenocarcinoma
• ASA I, II, or III
• laparoscopic LAR + DST
• with or without preoperative radio- or chemotherapy
• no distal metastasis
• no preoperative bowel obstruction
• no preventive ileostomy or colostomy
• patients and their families can understand and are willing to participate in this study and provide written informed consent

Exclusion Criteria

• emergency operation
• preoperative abnormal liver function
• tatme or ISR procedure (healing process might differ from anterior resection)
• severe postoperative (Clavien-Dindo grade III IV V) complications other than anastomotic leak
• severe perioperative infection unrelated to anastomotic leak
• patients with serious mental illness
• pregnant or breastfeeding women
• patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with TDT removal guided by postoperative CRP trajectory	removal of transanal drainage tube	-

Primary Outcome Measures

Name	Time	Method
anastomotic rate	30 days after surgery	anastomotic rate

Secondary Outcome Measures

Name	Time	Method
the grades of anastomotic leak	30 days after surgery	The severity grading of anastomotic leak according to the International Study Group of Rectal Cancer
rates of diarrhea after transanal drainage tube removal	from transanal drainage tube removal to 30 days after surgery	rates of diarrhea after transanal drainage tube removal
visual analogue scale to assess anal postoperative pain	from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks	visual analogue scale of the included patients to assess the transanal drainage tube tolerability. Visual analogue scale ranges from 0-10. 0 indicates perfectly tolerated while 10 indicates complete intolerant and the tube has to be removed.
transanal drainage tube-related adverse events	from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks	transanal drainage tube-related adverse events such as bleeding and iatrogenic colonic perforations

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China