Anastomotic Leak, Rectal Cancer
Conditions
Brief 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
Interventions
DEVICEremoval of transanal drainage tube
removal of transanal drainage tube after laparoscopic anterior resection for rectal carcinoma according to postoperative CRP trajectory
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anastomotic rate | 30 days after surgery | anastomotic rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the grades of anastomotic leak | 30 days after surgery | The severity grading of anastomotic leak according to the International Study Group of Rectal Cancer |
| rates of diarrhea after transanal drainage tube removal | from transanal drainage tube removal to 30 days after surgery | rates of diarrhea after transanal drainage tube removal |
| visual analogue scale to assess anal postoperative pain | from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks | 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. |
| transanal drainage tube-related adverse events | from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks | transanal drainage tube-related adverse events such as bleeding and iatrogenic colonic perforations |
Countries
China
Contacts
Primary ContactXiang Zhang, M.D. Ph.D.
Backup ContactZhiqiang Cheng, M.D. Ph.D.
Outcome results
None listed