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Effects of staged surgery on anal function in patients with complex anal fistulas: a protocol for a prospective non-randomized controlled trial

Effects of staged surgery on anal function in patients with complex anal fistulas: a protocol for a prospective non-randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129042
Enrollment
Unknown
Registered
2026-07-29
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Complex anal fistulas

Interventions

The staged surgery group:None
Single-Stage Surgery Group:None

Sponsors

Shanghai University of Traditional Chinese Medicine Shuguang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 70 years; 2. Anal fistula classified as inter-sphincteric according to the Parks classification, with an external opening spanning multiple perianal quadrants; 3. No prior history of anal surgery (i.e., undergoing their first anal surgical procedure); 4. Voluntary participation in this clinical trial, provision of written informed consent, and willingness and ability to comply with clinical follow-up.

Exclusion criteria

Exclusion criteria: 1. Presence of any condition that precludes receipt of the study treatment, including religious or ethnic contraindications, diabetes, malignancy, intestinal tuberculosis, Crohn's disease, or acquired immunodeficiency syndrome (AIDS); 2. Presence of acute infection or poorly controlled local infectious foci; 3. Presence of severe comorbid conditions involving the heart, lungs, brain, liver, or kidneys; 4. Pregnancy, planned pregnancy, or current lactation; 5. Cognitive impairment that precludes the ability to complete questionnaire-based assessments.

Design outcomes

Primary

MeasureTime frame
Anorectal manometry parameters ;Fecal Incontinence Quality of Life Scale;

Secondary

MeasureTime frame
The Multidimensional Satisfaction Questionnaire;Decision Regret Scale;Clinical Outcomes: Record healing rates, healing times;Wound Response and Safety Evaluation ;Evaluation of postoperative dressing change burden;

Countries

China

Contacts

Public ContactLu Hong

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

my654-2@126.com+86 135 6442 3605

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026