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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05502354
Other study ID # CRC-2022-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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