Effect of anastomotic reinforcing sutures on the incidence of anastomotic leakage after radical resection of rectal cancer: a prospective cohort trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000039117

Enrollment

Unknown

Registered

2020-10-17

Start date

2020-11-01

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer

Interventions

suture group:Continuous suture of anastomotic stoma

non-suture control group:no suture of anastomotic stoma

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with age > 18 years and <= 80 years old; 2. Patients with primary colorectal adenocarcinoma diagnosed by colonoscopy;the distance between tumor and anus was less than 10 cm; 3. Laparoscopic radical anterior rectal resection is to be performed.

Exclusion criteria

Exclusion criteria: 1. Participated in other clinical trials within 4 weeks before the start of this study; 2. Preoperative local neoadjuvant radiotherapy for rectal cancer; 3. Local T4b of rectal cancer may be unresectable; 4. Simultaneous or heterochronous (within 5 years) malignant tumor; 5. there are tumors or metastases in the organs around the rectum or pelvic floor, need to be resected in combination with the organs around the rectum; 6. Severe edema of the proximal colon caused by intestinal obstruction; 7. There are many anastomoses in the abdominal cavity; 8. Abdominal cavity has extensive inflammation, such as intestinal perforation, intestinal bleeding and other emergency operations; 9. ASA grade IV to grade V; 10. Pregnant or lactating women; 11. Serious cardiovascular disease (i.e. indicators more than twice the normal value), uncontrollable infection, or other uncontrollable comorbidities; 12. Serious mental illness; 13. Due to family, social, or geographical constraints, the trial protocol or follow-up plan could not be completed.

Design outcomes

Primary

Measure	Time frame
Anastomotic leakage;	—

Secondary

Measure	Time frame
Anastomotic bleeding;anastomotic stenosis;hospital stay;	—

Countries

China

Contacts

Public ContactLi xiaohua

State Key Laboratory of Cancer Biology & Xijing Hospital of Digestive Diseases; the Air Force Military Medical University,

edficrango@163.com+86 19991901686

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026