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This study evaluated two sphincter-preserving surgical techniques for transsphincteric anal fistula: standard ligation of the intersphincteric fistula tract (LIFT) and modified LIFT via a lateral approach. Adult patients with MRI-confirmed transsphincteric anal fistula were randomly assigned to one of the two procedures. The main outcome was wound healing time. Other outcomes included early recurrence or persistence of the fistula, postoperative pain, and fecal continence during 12 weeks of follow-up.
This was a prospective, single-center, randomized, parallel-group comparative surgical study conducted at the Department of General Surgery, Kayseri City Training and Research Hospital, Türkiye. The study included adult patients aged 18 to 75 years with magnetic resonance imaging-confirmed transsphincteric anal fistula who met the eligibility criteria and provided written informed consent.
Participants were randomly assigned in a 1:1 ratio to undergo either standard ligation of the intersphincteric fistula tract (LIFT) or modified LIFT via a lateral approach. All patients were evaluated by the same surgical team, and postoperative follow-up was performed at weeks 1, 4, 8, and 12.
The study compared early clinical outcomes between the two procedures, including wound healing time, early recurrence or persistence, postoperative pain, and fecal continence. The study was approved by the Kayseri City Hospital Clinical Research Ethics Committee before patient enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified LIFT via a Lateral Approach | Active Comparator | Participants assigned to this arm underwent modified LIFT via a lateral approach. The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at this level, and the remaining defect and internal opening were closed while preserving sphincter integrity. |
|
| Standard LIFT | Active Comparator | Participants assigned to this arm underwent standard ligation of the intersphincteric fistula tract (LIFT). The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard LIFT | Procedure | Standard ligation of the intersphincteric fistula tract was performed. The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing Time | Time from surgery to complete clinical epithelialization of the perianal wound without discharge. | Up to 12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Early Recurrence or Persistence of Anal Fistula | Presence of persistent or recurrent fistula-related symptoms or clinical findings during postoperative follow-up. | Postoperative weeks 1, 4, 8, and 12 |
| Postoperative Pain Assessed Using the Visual Analog Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TuÄŸberk Tok, MD | Kayseri City Training and Research Hospital | Principal Investigator |
| Yusuf Sevim, MD | Kayseri City Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kayseri City Training and Research Hospital | Kayseri | Kayseri | 38300 | Turkey (Türkiye) |
Individual participant data will not be publicly shared due to ethical, institutional, and privacy restrictions. De-identified data may be available from the corresponding investigator upon reasonable request, subject to institutional approval.
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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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| Modified LIFT via a Lateral Approach | Procedure | Modified LIFT via a lateral approach was performed. The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at that level, and the remaining defect and internal opening were closed. |
|
Postoperative pain will be assessed using the Visual Analog Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. |
| Postoperative weeks 1, 4, 8, and 12 |
| Fecal Continence Assessed Using the Wexner Fecal Incontinence Score | Fecal continence will be assessed using the Wexner Fecal Incontinence Score. The score ranges from 0 to 20, where 0 indicates perfect continence and 20 indicates complete fecal incontinence. Higher scores indicate worse continence. | Postoperative weeks 1, 4, 8, and 12 |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |