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Trial Title:
CRP-guided Transanal Drainage Removal After Rectal Surgery
NCT ID:
NCT05502354
Condition:
Rectal Cancer
Anastomotic Leak
Conditions: Official terms:
Anastomotic Leak
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
removal of transanal drainage tube
Description:
removal of transanal drainage tube after laparoscopic anterior resection for rectal
carcinoma according to postoperative CRP trajectory
Arm group label:
patients with TDT removal guided by postoperative CRP trajectory
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiang Zhang
Phone:
+8618560089182
Email:
xiang.zhang02@hotmail.com
Start date:
April 1, 2023
Completion date:
February 1, 2025
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05502354
