Novel stent combined film case of isolating faeces to prevent anastomotic leakage in low rectal cancer:a clinical study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300072321

Enrollment

Unknown

Registered

2023-06-09

Start date

2022-09-21

Completion date

Unknown

Last updated

2023-06-18

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

Conditions

anastomotic leakage

Interventions

intervention group:Novel stent combined film case of isolating faeces

control group:defunctioning stoma

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-80 years, sex not restricted; (2) The primary single rectal adenocarcinoma was diagnosed by Enteroscopic biopsy, and there were no distant metastases; (3) The preoperative examination assessed the tumor to be less than 7 cm from the anal verge with a preliminary estimate that the anus could be preserved; (4) Eastern Cooperative Oncology Group (ECoG) performance status score = 2; (5) Subjects volunteered to participate in this clinical study and signed informed consent for surgery.

Exclusion criteria

Exclusion criteria: (1) History of previous rectal surgery; (2) Also had other conditions involving the rectum such as: familial polyposis coli, hereditary nonpolyposis colorectal, active Crohn's disease or active ulcerative colitis; (3) Severe impairment of cardiopulmonary function or have other underlying diseases that cannot tolerate surgery; (4) Pregnant or planned pregnant women, lactating women; (5) History of previous rectal chemoradiotherapy; (6) Severe complications intolerant of surgery or requiring emergency surgery; (7) Iodine allergy (8) Change of surgical approach for various reasons, withdraw halfway, did not complete entire course of treatment

Design outcomes

Primary

Measure	Time frame
anastomotic leakage;	—

Secondary

Measure	Time frame
Total complications;Wound?infection;Abdominal infection;Incomplete?intestinal?obstruction;Dysuria;Pulmonary infection;Reoperation;Hypokalaemia;Hyponatremia;operating time;Blood loss;Postoperative exhaust time;Postoperative defecation time;Extubation time;Postoperative activity time;Postoperative fasting time;length of hospital stay;Hospitalization cost;	—

Countries

China

Contacts

Public ContactLian Bai

Department of gastrointestinal surgery, Yongchuan hospital, Chongqing Medical

2840996478@qq.com+86 189 9617 6213

Outcome results

None listed

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