NCT04351074

Brief Summary

78 patients with transsphincteric fistula allocated into two groups group A underwent LIFT group B u nderwent fistulectomy , comparison between the outcome og both procedures

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

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

March 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

April 15, 2020

Last Update Submit

April 16, 2020

Conditions

Transsphincteric Anal Fistula

Keywords

anal fistula, LIFT, fistulectomy

Outcome Measures

Primary Outcomes (5)

  • recurrence

    recurrence of the fistula after complete healing of wound detected by clinical examination

    8 weeks

  • incontinence

    inability to control flatus or stool detected by Vaizy patient questionnaire

    1 week

  • operative time

    time from 1st incision to wound packing counted in minutes

    1 hour

  • hospital stay

    from admission to discharge measured in days

    1 day

  • postoperative pain

    degree of pain measured by patient questionnaire visual analogue scale(from 1 to 10) the high the score the more sever the pain is

    1 day

Secondary Outcomes (1)

  • wound complications

    1 week

Study Arms (2)

group A , LIFT

ACTIVE COMPARATOR

39 patients underwnt ligation of the intersphincteric track( LIFT) for treatment of transsphincteric fistula

Procedure: LIFT

group B fistulectomy

ACTIVE COMPARATOR

39 patients under went fistulectomy for treatment of transsphincteric fistula

Procedure: fistulectomy

Interventions

LIFTPROCEDURE

ligation of the intersphincteric fistula track

group A , LIFT
fistulectomyPROCEDURE

excision of the fistulous track with its internal and external orifices

group B fistulectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with transsphincteric anal fistula

You may not qualify if:

  • Anorectal malignancy.
  • Patient with previous radiotherapy to the region.
  • Those with fistula due to specific disease as Crohn's disease.
  • Patients with anal incontinence.
  • Patients with perianal collections.
  • Patients on cytotoxic or immunosuppressive therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig Faculty of Medicine

Zagazig, Sharqya, 44519, Egypt

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • hazem nour, MD

    zag university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: group A (39 patients): Patients underwent intersphincteric ligation of fistulous track (LIFT) group B (39 patients): Patients underwent fistulectomy.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

March 1, 2018

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

EG(1)