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Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

Fistuolotomy With or Without Marsupialization for Treatment of Simple Anal Fistula: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03595839
Enrollment
60
Registered
2018-07-23
Start date
2017-02-01
Completion date
2018-07-01
Last updated
2018-10-18

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

Conditions

Anal Fistula

Brief summary

Patients with simple anal fistula will undergo fistulotomy operation and will be divided into two groups: the first will undergo marsupialization of the laid open fistula track and second group will not undergo marsupialization. The effect of marsupialization on healing of anal fistula will be compared postoperatively.

Interventions

PROCEDUREFistulotomy

The fistula track is laid open after complete probing till the internal opening

The laid open track will be marsupialized using interrupted absorbable sutures

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Both genders * Age: 18-65 years * All Patients with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers).

Exclusion criteria

* High trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary. * Recurrent anal fistulas. * Patients associated with anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases and TB. * High risk patients according to ASA (American society of anesthesiologists ) * Any degree of incontinence. * Patients with previous anal surgery.

Design outcomes

Primary

MeasureTime frameDescription
Time to complete healing8 weeksThe duration of time required to achieve complete wound healing

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026