CRP-guided Transanal Drainage Removal After Rectal Surgery

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05502354
• Other study ID #: CRC-2022-01
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: November 2023
• Source: Qilu Hospital of Shandong University
• Contact: Xiang Zhang, M.D. Ph.D.
• Phone: +8618560089182
• Email: xiang.zhang02[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Rectal Cancer

Intervention

Device:
• removal of transanal drainage tube
removal of transanal drainage tube after laparoscopic anterior resection for rectal carcinoma according to postoperative CRP trajectory

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anastomotic rate	anastomotic rate	30 days after surgery
Secondary	the grades of anastomotic leak	The severity grading of anastomotic leak according to the International Study Group of Rectal Cancer	30 days after surgery
Secondary	rates of diarrhea after transanal drainage tube removal	rates of diarrhea after transanal drainage tube removal	from transanal drainage tube removal to 30 days after surgery
Secondary	visual analogue scale to assess anal postoperative pain	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.	from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks
Secondary	transanal drainage tube-related adverse events	transanal drainage tube-related adverse events such as bleeding and iatrogenic colonic perforations	from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks