An interventional study of Laser ablation and Conventional Open Fistulectomy in Perianal Fistula and Anal Fistula, sponsored by PNS Hafeez - Naval Hospital. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by PNS Hafeez - Naval Hospital · Not applicable, Interventional, and Treatment
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.
169 studies on the registry are indexed under Rectal Fistula; 45 are open to participants now.
This study's planned enrollment of 72 is close to the median of 66 across 115 interventional studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →PNS Hafeez - Naval Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo laser-assisted anal fistula surgery according to institutional protocol.
Procedure: Laser ablation · Procedure: Conventional Open Fistulectomy
Patients will undergo conventional open fistulectomy according to institutional protocol.
Procedure: Laser ablation · Procedure: Conventional Open Fistulectomy
Laser-assisted anal fistula surgery for uncomplicated perianal fistula.
Conventional open fistulectomy for uncomplicated perianal fistula.
Post operative recovery time
Time from the end of surgery until return to work with no residual anal pain and no bleeding or discharge.
Time frame: 2 weeks after surgery
Recurrance of perianal fistula
Reappearance of perianal fistula after surgery.
Time frame: 6 months after surgery
Plan to share: Undecided — 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.
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Mar 2027, 8 months later.
Of 53 non-industry interventional studies with no phase under Rectal Fistula, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 8 months is below that.
Counting every sponsor, half of 57 studies reached it within 27 months; a quarter within 11 and three quarters within 38.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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PNS Hafeez - Naval Hospital