CRP-guided Transanal Drainage Removal After Rectal Surgery

Shandong University

Status

Enrolling

Conditions

Anastomotic Leak

Rectal Cancer

Treatments

Device: removal of transanal drainage tube

Study type

Interventional

Funder types

Other

Identifiers

NCT05502354

CRC-2022-01

Details and patient eligibility

About

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

Enrollment

250 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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