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Laparoscopic stapler in the treatment of rectovaginal fistula: a prospective randomized controlled trial

Laparoscopic stapler in the treatment of rectovaginal fistula: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050301
Enrollment
Unknown
Registered
2021-08-26
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Rectovaginal Fistula

Interventions

Endorectal advancement flap repair group:Endorectal advancement flap repair surgery
Laparoscopic stapler group:Laparoscopic staple

Sponsors

The Sixth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients were diagnosed with mid-low RVF; 2.Aged 18 to 80 years; 3.Patients and their families understand and agree to participate in this study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.The RVF with infection or abscess; 2.The RVF with inflammatory bowel disease or the RVF were caused by inflammatory bowel disease; 3.Combined with colorectal tumor; 4.Participated in or is currently participating in other clinical trials within 4 weeks prior to inclusion; 5.Combined with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or other severe underlying diseases can not tolerate surgery; 6.Having a history of serious mental illness; 7.Researchers believe that the clinical or laboratory situation of patients is not suitable for the study.

Design outcomes

Primary

MeasureTime frame
1 year cure rate after operation;Rate of replaced rectovaginal fistula;

Secondary

MeasureTime frame
Postoperative anal function;Quality of life index;Perioperative situation;

Countries

China

Contacts

Public ContactLin Hongcheng

The Sixth Affiliated Hospital of Sun Yat-sen University

linhongcheng@hotmail.com+86 15915815776

Outcome results

None listed

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