Fistula in AnoLASERLIFTNCT06212739
Post-op Pain After Fistula Laser Closure or Ligation of the Intersphincteric Tract for Anal Fistula
A study testing Laser and LIFT in people with Fistula in Ano, run by University of Malaya at 1 site in Malaysia.
Trial summary
This is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fistula in Ano
- What is being tested?
- Laser and LIFT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2018to 2 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complex transphincteric fistulas:
- high transphincteric fistula, involving more than 30% of the external anal sphincter
- Multiple fistulas
- Anterior fistulas
- 18-75 years old
- Able to give consent
- New or recurrent fistulas
- Fistulas with or without setons
Who cannot join
- Active perianal sepsis requiring drainage
- Fistulas of non-cryptogladular origin- Crohn's, TB, malignancy
- Expected lifespan less than 6 months
- Pregnant women
- Patients with more than 1 definitive surgery done for the fistula before
- Patients with human immunodeficiency virus infection
- Patients with pre-existing chronic pain disorders
- Patients with Non-steroidal Anti-inflammatory Drug (NSAIDS) / Paracetamol allergies
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: Comparison of Post-operative Pain Between Fistula Laser Closure and Ligation of the Intersphincteric Tract in the Treatment of Anal Fistula - a Randomized Controlled Trial. (LASERLIFT)
This is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon.
Read the detailed description
Patients with high transphincteric fistulas were blinded and randomized to either laser or ligation of the fistula tract (LIFT). Pain scores at rest and movement, at 6 and 24 hours post operatively were measured using the visual analogue scale (VAS). Operative time was measured in minutes Continence and quality of life was assessed via the Wexner incontinence scale and SF-36 questionnaire respectively at 0, 3 and 6 months post-operatively.
- Conditions
- Fistula in Ano
- Being tested
- Laser, LIFT
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserProcedure or surgery
Also called FiLAC
Diode laser used to effect closure of the anal fistula tract
LIFTProcedure or surgery
Also called Ligation of the Intersphincteric Fistula Tract
The intersphincteric portion of the fistula is excised and ligated.
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Patients treated using fistula laser closure. Receives: Procedure: Laser |
| LIFT | Active comparator | Patients treated using ligation of intersphincteric fistula tract. Receives: Procedure: LIFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain score
Post-operative pain will be assessed by a blinded assessor using the Visual Analogue Scale (VAS), a validated pain score.
Measured: 6 hours, 24 hours
Secondary outcomes (6)
Operative time
Median operative time was to compare the two arms
Measured: Intraoperative
Continence
The Wexner score was used to assess pre- and post-operative continence. Minimum score is 3, maximum score is 12. The lower the score, the worse the incontinence.
Measured: At baseline, and at 1 week, 1 month and 6 months post-operatively
SF36
The SF36 was used to assess pre- and post-operative quality of life.
Measured: At baseline, and at 1 week, 1 month and 6 months post-operatively
Return to work
Days until return to work
Measured: Number of days taken to return to work, assessed at 6 months post-operatively
Duration of analgesia use
The duration in days that the patient needed to use analgesia post-operative
Measured: Number of days until cessation of analgesia use, assessed at 1 week or 1 month, whichever is shorter
Failure rate
Failure to heal was defined as failure of fistula closure (persistent discharge) beyond 6 months' post-operatively
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fistula in AnoStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- April C Roslani, MS, FACS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212739
- Sponsor's protocol ID
- MREC 201892-6637
- Acronym
- LASERLIFT
- Status last verified
- Dec 2023
- First submitted
- 25 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Low JQL, Rajandram R, Aziz MRA, Roslani AC. Postoperative pain following laser fistula closure versus ligation of the intersphincteric fistula tract: A prospective double-blinded randomized controlled trial. World J Surg. 2024 Aug;48(8):1990-1999. doi: 10.1002/wjs.12242. Epub 2024 Jun 6.
PubMed 38844401
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Pain Between Fistula Laser Closure and Ligation of the Intersphincteric Tract in the Treatment of Anal Fistula - a Randomized Controlled Trial. (LASERLIFT)
- ClinicalTrials.gov ID
- NCT06212739
- Acronym / sponsor ID
- LASERLIFT / MREC 201892-6637
- Conditions
- Fistula in Ano
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon.
Detailed description
Patients with high transphincteric fistulas were blinded and randomized to either laser or ligation of the fistula tract (LIFT). Pain scores at rest and movement, at 6 and 24 hours post operatively were measured using the visual analogue scale (VAS). Operative time was measured in minutes Continence and quality of life was assessed via the Wexner incontinence scale and SF-36 questionnaire respectively at 0, 3 and 6 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Procedure: LaserPatients treated using fistula laser closure. |
| LIFT | Active comparator | Procedure: LIFTPatients treated using ligation of intersphincteric fistula tract. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Complex transphincteric fistulas:
- high transphincteric fistula, involving more than 30% of the external anal sphincter
- Multiple fistulas
- Anterior fistulas
- 18-75 years old
Key exclusion criteria (8 listed)
- Active perianal sepsis requiring drainage
- Fistulas of non-cryptogladular origin- Crohn's, TB, malignancy
- Expected lifespan less than 6 months
- Pregnant women
- Patients with more than 1 definitive surgery done for the fistula before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserAlso: FiLACDiode laser used to effect closure of the anal fistula tract | Procedure or surgery | Laser |
| LIFTAlso: Ligation of the Intersphincteric Fistula TractThe intersphincteric portion of the fistula is excised and ligated. | Procedure or surgery | LIFT |
Primary outcome
Post-operative pain score
Time frame: 6 hours, 24 hours
Post-operative pain will be assessed by a blinded assessor using the Visual Analogue Scale (VAS), a validated pain score.
6 secondary outcomes
Operative time
Time frame: Intraoperative
Continence
Time frame: At baseline, and at 1 week, 1 month and 6 months post-operatively
SF36
Time frame: At baseline, and at 1 week, 1 month and 6 months post-operatively
Return to work
Time frame: Number of days taken to return to work, assessed at 6 months post-operatively
Duration of analgesia use
Time frame: Number of days until cessation of analgesia use, assessed at 1 week or 1 month, whichever is shorter
Failure rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Derived from this study: PubMed 38844401Low JQL, Rajandram R, Aziz MRA, Roslani AC. Postoperative pain following laser fistula closure versus ligation of the intersphincteric fistula tract: A prospective double-blinded randomized controlled trial. World J Surg. 2024 Aug;48(8):1990-1999. doi: 10.1002/wjs.12242. Epub 2024 Jun 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
April C Roslani, MS, FACS principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser and LIFT in people with Fistula in Ano, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain score (time frame: 6 hours, 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06212739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.