CRP-guided Transanal Drainage Removal After Rectal Surgery

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Rectal Cancer, Anastomotic Leak

Intervention / Treatment
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* Device: removal of transanal drainage tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with TDT removal guided by postoperative CRP trajectory<br> | Device: removal of transanal drainage tube<br>* removal of transanal drainage tube after laparoscopic anterior resection for rectal carcinoma according to postoperative CRP trajectory<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anastomotic rate | anastomotic rate | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the grades of anastomotic leak | The severity grading of anastomotic leak according to the International Study Group of Rectal Cancer | 30 days after surgery | 
| 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 | 
| 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 | 
| 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 |