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This is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser | Experimental | Patients treated using fistula laser closure. |
|
| LIFT | Active Comparator | Patients treated using ligation of intersphincteric fistula tract. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser | Procedure | Diode laser used to effect closure of the anal fistula tract |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain score | Post-operative pain will be assessed by a blinded assessor using the Visual Analogue Scale (VAS), a validated pain score. | 6 hours, 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Median operative time was to compare the two arms | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| April C Roslani, MS, FACS | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Centre | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38844401 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2018 | Dec 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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Randomized controlled trial
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Outcomes assessor was blinded to the intervention.
| LIFT | Procedure | The intersphincteric portion of the fistula is excised and ligated. |
|
|
| 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. | At baseline, and at 1 week, 1 month and 6 months post-operatively |
| Return to work | Days until return to work | 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 | 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 | 6 months |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |