NCT06616662

Brief Summary

a study that detect the most suitable surgical techniques for treating transsphincteric fistula

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

September 23, 2024

Last Update Submit

September 25, 2024

Conditions

Perianal Fistula

Keywords

perianal fistula,flap,ligation

Outcome Measures

Primary Outcomes (1)

  • healing rate

    incidence of healing in both approaches

    three years

Secondary Outcomes (1)

  • incontinence

    three years

Study Arms (2)

LIFT

Procedure: LIFT

MAF

Procedure: MAF

Interventions

MAFPROCEDURE

use mucosal advancement flap to treat PAF

MAF
LIFTPROCEDURE

use LIFT surgery for treating PAF

LIFT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

two hundred and fifty seven elderly patient with PAF

You may qualify if:

  • elderly persons with PAF

You may not qualify if:

  • recurrent fistula
  • associated autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

Location

Related Publications (1)

  • Habeeb TAAM, Chiaretti M, Kryvoruchko IA, Pesce A, Kechagias A, Elias AA, Adam AAM, Gadallah MA, Ali Ahmed SM, Khyrallh A, Alsayed MH, Tharwat Kamel Awad E, Elshafey MH, Abo Alsaad MI, Ali AK, Elbelkasi H, Abou Zaid MA, Youssef HAA, Al-Zamek MMF, Fiad A, Elshahidy TM, Elballat MR, El Taher AK, Mohamed MMM, AboZeid AK, Mansour MI, Yassin MA, Arafa AS, Lotfy M, Mousa B, Atef B, Naguib SM, Heggy IA, Elnemr M, Zaitoun MA, AbdAllah ES, Moussa MS, Hamed AEM, Elsayed RS. Mucosal advancement flap versus ligation of the inter-sphincteric fistula tract for management of trans-sphincteric perianal fistulas in the elderly: a retrospective study. Int J Colorectal Dis. 2025 Mar 12;40(1):61. doi: 10.1007/s00384-025-04846-5.

    PMID: 40072575DERIVED

Study Officials

  • Tamer. A.A.M. Habeeb

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof of general and laparoscopic surgery

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 27, 2024

Study Start

July 1, 2018

Primary Completion

July 1, 2021

Study Completion

July 1, 2024

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)