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Prospective, open-label, single-arm study of nickel-titanium alloy coated stent application at rectal anastomosis

Prospective, open-label, single-arm study of nickel-titanium alloy coated stent application at rectal anastomosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098199
Enrollment
Unknown
Registered
2025-03-04
Start date
2022-05-10
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Rectal cancer

Interventions

Experimental group:All study participants underwent radical rectal cancer resection (laparoscopic or open surgery), after the intestinal anastomosis, a self-expanding fecal diversion stent was placed

Sponsors

TungWah Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Agree to signed the informed consent form, expressing my willingness and ability to adhere to the scheduled visits, research treatments, laboratory tests, and other experimental procedures; 2. Aged between 18 and 75 years; 3. Confirmed with rectal adenocarcinoma through pathology or cytology; 4. Preoperative CT or MRI has shown the rectal tumor to be <=10cm from the anal verge; 5. ECOG performance score of 0-1; 6. Preoperative assessment indicates that rectal cancer resection and anastomosis surgery is feasible, achieving a radical level of R0.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Preoperative endoscopic examination of the tumor periphery showed that the endoscope could not pass through; 3. Emergency surgeons; 4. Intraoperative prolapse anastomosis is required (Parks, TaTME) 5. Combined with intestinal obstruction; 6. History of pelvic and abdominal radiation therapy before surgery; 7. Previous history of colorectal disease or surgery (excluding appendectomy); 8. Suffer from mental disorders and serious cardiovascular, respiratory, kidney, liver diseases or diabetes.

Design outcomes

Primary

MeasureTime frame
Incidence of anastomotic leakage 5-10 days post-surgery;

Secondary

MeasureTime frame
Pain scores;Intestinal wall perforation;Bleeding;

Countries

China

Contacts

Public ContactJunjiu Li

TungWah Hospital

13527965368@163.com+86 135 2796 5368

Outcome results

None listed

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