CRP-guided Transanal Drainage Removal After Rectal Surgery

Qilu Hospital of Shandong University250 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

250

Conditions

Rectal Cancer Anastomotic Leak

Interventions

removal of transanal drainage tubeDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

anastomotic rate

Time frame: 30 days after surgery

Secondary Outcomes

the grades of anastomotic leak

The severity grading of anastomotic leak according to the International Study Group of Rectal Cancer

Time frame: 30 days after surgery

rates of diarrhea after transanal drainage tube removal

Time frame: from transanal drainage tube removal to 30 days after surgery

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.

Time frame: from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks

transanal drainage tube-related adverse events

transanal drainage tube-related adverse events such as bleeding and iatrogenic colonic perforations

Time frame: from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks

Central Contacts

Xiang Zhang, M.D. Ph.D.

CONTACT

+8618560089182 xiang.zhang02@hotmail.com

Zhiqiang Cheng, M.D. Ph.D.

CONTACT

+8618560085238 hill988276@sina.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.