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Completed

NCT Number: NCT03595839

Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

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.

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Key information

Conditions

Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fistulotomy

Procedure

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

Marsupialization

Procedure

The laid open track will be marsupialized using interrupted absorbable sutures

Primary outcomes

  1. Time to complete healing

    Time frame: 8 weeks

    The duration of time required to achieve complete wound healing

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2018
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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