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This randomized controlled trial aims to compare conventional open fistulectomy and laser ablation in the treatment of uncomplicated perianal fistula. The study will evaluate postoperative recovery time and recurrence rates between the two procedures. A total of 72 patients with uncomplicated perianal fistula will be randomly assigned to either conventional open fistulectomy or laser ablation and followed for six months after surgery.
Perianal fistula is a common anorectal condition that usually requires surgical treatment. Conventional open fistulectomy has been widely used because of its established effectiveness; however, it may be associated with prolonged recovery. Laser-assisted anal fistula surgery is a newer minimally invasive technique that may offer faster postoperative recovery and less tissue damage.
Published studies have reported conflicting results regarding the superiority of either technique in terms of postoperative recovery and recurrence. Therefore, this randomized controlled trial is being conducted to compare conventional open fistulectomy and laser ablation in patients with uncomplicated perianal fistula.
The study will be conducted at the Department of Surgery, PNS Hafeez Hospital, Islamabad. Seventy-two patients aged 18 to 55 years with uncomplicated perianal fistula will be enrolled and randomized in a 1:1 ratio by paper lottery method into two groups. Group C will undergo conventional open fistulectomy, and Group L will undergo laser-assisted anal fistula surgery.
The primary outcome measures are postoperative recovery time and recurrence of perianal fistula within six months after surgery. Patients will be followed at two weeks and six months postoperatively. The findings of this study may help determine the optimal surgical approach for uncomplicated perianal fistula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Ablation | Experimental | Patients will undergo laser-assisted anal fistula surgery according to institutional protocol. |
|
| Conventional Open Fistulectomy | Active Comparator | Patients will undergo conventional open fistulectomy according to institutional protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser ablation | Procedure | Laser-assisted anal fistula surgery for uncomplicated perianal fistula. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post operative recovery time | Time from the end of surgery until return to work with no residual anal pain and no bleeding or discharge. | 2 weeks after surgery |
| Recurrance of perianal fistula | Reappearance of perianal fistula after surgery. | 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fahad Raza Ansari, MBBS, FCPS Resident | Contact | +923215550121 | sunny_slf@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PNS Hafeez Naval Hospital | Islamabad | 44400 | Pakistan |
The investigators have not yet determined whether de-identified individual participant data will be shared with other researchers. Any future data sharing will be subject to institutional policies, ethical approval, and participant confidentiality requirements.
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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 |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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Participants will be randomized in a 1:1 ratio to either conventional open fistulectomy or laser-assisted anal fistula surgery and followed prospectively.
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| Conventional Open Fistulectomy | Procedure | Conventional open fistulectomy for uncomplicated perianal fistula. |
|
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |