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To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ≤5cm Rectal, Pre-chemo, Leak Test | Experimental | Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy and intraoperative leak testing. |
|
| ≤5cm Rectal, Pre-chemo, No Leak Test | No Intervention | Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing. | |
| ≤5cm Rectal, No pre-chemo, Leak Test | Experimental | Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing. |
|
| ≤5cm Rectal, No pre-chemo, No Leak Test | No Intervention | Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing. | |
| >5cm Colorectal, Pre-chemo, Leak Test | Experimental | Patients with colorectal cancer > 5 cm from the anus, received preoperative chemotherapy, and underwent intraoperative leak testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative leak testing | Procedure | ◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Anastomotic Leak within 30 days | Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Postoperative Complications within 30 days | Count the number of participants who develop postoperative bleeding, anastomotic stenosis, and intra-abdominal infection within 30 days after colorectal cancer surgery. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunhong Tian, doctor | Contact | 13508087719 | drtianyunhong@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanchong Central Hospital | Recruiting | Nanchong | Sichuan | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| >5cm Colorectal, Pre-chemo, No Leak Test | No Intervention | Patients with colorectal cancer > 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing. |
| >5cm Colorectal, No pre-chemo, Leak Test | Experimental | Patients with colorectal cancer > 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing. |
|
| >5cm Colorectal, No pre-chemo, No Leak Test | No Intervention | Patients with colorectal cancer > 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing. |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |