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Enhanced recovery after surgery to change early post-operative feeding method in congenital pyriform sinus fistula patients after transoral CO2 laser cauterization

Enhanced recovery after surgery to change early post-operative feeding method in congenital pyriform sinus fistula patients after transoral CO2 laser cauterization

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081409
Enrollment
Unknown
Registered
2024-02-29
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Congenital pyriform sinus fistula

Interventions

Intervention group:Patients with congenital pyriform sinus fistula who directly resume oral feeding after transoral CO2 laser cauterization.
Control group:Patients with congenital pyriform sinus fistula who feed via gastric tube after transoral CO2 laser cauterization.

Sponsors

Eye & ENT Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged =8 years, confirmed with a diagnosis of 'congenital pyriform sinus fistula' through imaging evaluation.; 2. Patients with congenital pyriform sinus fistula who are not currently infected or have been free from acute infection for more than 1 month.; 3. Patients who could tolerate general anesthesia and cooperate with treatment.; 4. Patients or their guardians who are willing to provide informed consent and can cooperate with follow-up procedures.

Exclusion criteria

Exclusion criteria: 1. Patients with congenital pyriform sinus fistula who cannot achieve good exposure of the inner fistula orifice during the procedure of undergoing transoral CO2 laser cauterization.; 2. Patients with poor compliance, unwilling to cooperate with the treatment, or resistant to changes in the treatment plan.; 3. Lack of complete clinical information and complete follow-up.; 4. The investigator deems to have other reasons unsuitable for participation in this clinical study.

Design outcomes

Secondary

MeasureTime frame
Overall hospitalization cost;Postoperation pain;

Primary

MeasureTime frame
Total number of days in hospital;Surgical site infection after operation;Degree of swallowing function postoperatively;Degree of speech function postoperatively;Time of oral feeding;Postoperative quality of life;

Countries

China

Contacts

Public ContactChengzhi Xu

Eye & ENT Hospital, Fudan University

xczmed@126.com+86 181 1758 9629

Outcome results

None listed

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