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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with TDT removal guided by postoperative CRP trajectory | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| removal of transanal drainage tube | Device | removal of transanal drainage tube after laparoscopic anterior resection for rectal carcinoma according to postoperative CRP trajectory |
| Measure | Description | Time Frame |
|---|---|---|
| anastomotic rate | anastomotic rate | 30 days after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Zhang, M.D. Ph.D. | Contact | +8618560089182 | xiang.zhang02@hotmail.com | |
| Zhiqiang Cheng, M.D. Ph.D. | Contact | +8618560085238 | hill988276@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Kexin Wang, M.D. Ph.D. | Qilu Hospital of Shandong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |