A Comparative Study of Clinical Outcomes Between Leak Testing and No Leak Testing for Anastomosis in Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications.

• Aged between 18 and 85 years.

• American Society of Anesthesiologists (ASA) physical status classification is I - III.

• The patient or his/her legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process.

Locations
Other Locations
China
Nanchong Central Hospital
RECRUITING
Nanchong
Contact Information
Primary
Yunhong Tian, doctor
drtianyunhong@126.com
13508087719
Time Frame
Start Date: 2024-12-22
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 264
Treatments
Experimental: ≤5cm Rectal, Pre-chemo, Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy and intraoperative leak testing.
No_intervention: ≤5cm Rectal, Pre-chemo, No Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing.
Experimental: ≤5cm Rectal, No pre-chemo, Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing.
No_intervention: ≤5cm Rectal, No pre-chemo, No Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing.
Experimental: >5cm Colorectal, Pre-chemo, Leak Test
Patients with colorectal cancer \> 5 cm from the anus, received preoperative chemotherapy, and underwent intraoperative leak testing.
No_intervention: >5cm Colorectal, Pre-chemo, No Leak Test
Patients with colorectal cancer \> 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing.
Experimental: >5cm Colorectal, No pre-chemo, Leak Test
Patients with colorectal cancer \> 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing.
No_intervention: >5cm Colorectal, No pre-chemo, No Leak Test
Patients with colorectal cancer \> 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing.
Related Therapeutic Areas
Endoscopy
Colonoscopy
Colorectal Cancer
Sponsors
Leads: Nanchong Central Hospital

This content was sourced from clinicaltrials.gov

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