- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07579715
Comparison Of Surgical Outcomes Between Ligation Of Intersphincteric Fistula Tract And Fistulotomy With Seton In Perianal Fistula (LIFT-SETON)
Comparison Of Surgical Outcomes Between Ligation Of Intersphincteric Fistula Tract And Fistulotomy With Seton In The Management Of Perianal Fistula: An Analytical Comparative Study
This study aims to compare two commonly used surgical techniques for the treatment of perianal fistula: Ligation of the Intersphincteric Fistula Tract (LIFT) and fistulotomy with seton. Perianal fistula is a condition that can cause pain, discharge, and significant discomfort, and its treatment remains challenging due to the risk of recurrence and potential loss of bowel control after surgery.
The LIFT procedure is a sphincter-preserving technique designed to treat the fistula without damaging the muscles responsible for continence. In contrast, fistulotomy with seton involves placing a thread (seton) in the fistula tract followed by gradual or staged division of the tract, which may carry a higher risk of affecting continence.
In this study, 100 adult patients diagnosed with perianal fistula will be included and divided into two groups based on the surgical procedure they undergo: LIFT or fistulotomy with seton. The outcomes of both procedures will be compared in terms of wound healing time, recurrence of the fistula, postoperative pain, and preservation of bowel continence.
The results of this study will help determine which surgical technique provides better recovery, fewer complications, and improved quality of life for patients.
Přehled studie
Postavení
Podmínky
Detailní popis
Perianal fistula (fistula-in-ano) is a common anorectal condition characterized by an abnormal tract between the anal canal and perianal skin. It is associated with recurrent infection, discharge, and discomfort, and often requires surgical management. However, the ideal surgical technique remains controversial due to the balance required between complete eradication of the fistula tract and preservation of anal sphincter function.
Traditional surgical approaches such as fistulotomy involve laying open the fistula tract but may result in varying degrees of sphincter muscle division, leading to potential fecal incontinence. To overcome this limitation, sphincter-preserving techniques such as the Ligation of the Intersphincteric Fistula Tract (LIFT) procedure have been introduced. LIFT involves identification and ligation of the fistula tract in the intersphincteric plane, thereby minimizing damage to the anal sphincter.
Fistulotomy with seton placement is another commonly practiced technique, especially for trans-sphincteric fistulas. The seton allows gradual drainage and fibrosis before definitive fistulotomy, potentially reducing the risk of uncontrolled sphincter division but still carrying a risk of incontinence.
Despite numerous international studies comparing these techniques, results remain inconsistent due to variations in study design, patient populations, and surgical expertise. Moreover, limited local data from Pakistan necessitates further research to guide clinical decision-making in this setting.
This analytical comparative study will be conducted at the Colorectal and General Surgery Department of Akbar Niazi Teaching Hospital, Islamabad. A total of 100 patients aged 18-65 years with primary trans-sphincteric or inter-sphincteric perianal fistula will be included using non-probability consecutive sampling. Patients will be allocated into two groups based on the surgical procedure performed: Group A (LIFT) and Group B (fistulotomy with seton).
Preoperative data including demographic characteristics, fistula type, and baseline continence scores will be recorded. Surgical procedures will be standardized and performed or supervised by experienced surgeons. Postoperative follow-up will be conducted at 2, 4, 8, and 12 weeks to assess outcomes.
The primary outcome of the study is preservation of fecal continence at 12 weeks, assessed using a validated continence scoring system. Secondary outcomes include wound healing time, recurrence rate, postoperative pain scores, and overall complication rate.
Data will be analyzed using statistical software. Continuous variables will be compared using independent-sample t-tests, while categorical variables will be analyzed using chi-square tests. A p-value of less than 0.05 will be considered statistically significant. Multivariate analysis may be performed to adjust for confounding factors.
This study aims to provide evidence on the comparative effectiveness and safety of LIFT versus fistulotomy with seton, helping surgeons select the most appropriate technique with optimal patient outcomes and minimal complications.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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-
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Islamabad, Pákistán, 44000
- Akbar Niazi Teaching Hospital, Islamabad Medical and Dental College
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Patients aged 18-65 years, both males and females
- Diagnosed with primary cryptoglandular perianal fistula
- Trans-sphincteric or inter-sphincteric fistula confirmed clinically ± imaging/proctoscopy
- Fit for surgery under anesthesia
- Willing to provide written informed consent
Exclusion Criteria:
- Recurrent perianal fistula (previous surgical intervention)
- Fistula secondary to Crohn's disease, tuberculosis, or malignancy Immunocompromised patients
- Pre-existing fecal incontinence (documented)
- Severe comorbidities making surgery unsafe (e.g., uncontrolled diabetes, severe hepatic/renal failure)
- Pregnancy
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Lift Group
Participants in this arm will undergo the Ligation of the Intersphincteric Fistula Tract (LIFT) procedure for the management of primary trans-sphincteric or inter-sphincteric perianal fistula.
This is a sphincter-preserving surgical technique in which the fistula tract is identified in the intersphincteric plane, ligated, and divided to close the internal opening while preserving anal sphincter integrity.
Postoperative outcomes, including wound healing time, recurrence, postoperative pain, and faecal continence, will be assessed and compared with the fistulotomy with seton group during follow-up.
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A sphincter-preserving surgical technique in which the fistula tract is identified in the intersphincteric plane, ligated, and divided to close the internal opening while preserving anal sphincter function.
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Aktivní komparátor: Fistulotomy With Seton Group
Participants in this arm will undergo fistulotomy with seton placement followed by definitive fistulotomy for the management of primary trans-sphincteric or inter-sphincteric perianal fistula.
The seton is used initially to allow drainage and fibrosis of the fistula tract, followed by surgical laying open of the tract (fistulotomy) as definitive treatment.
Postoperative outcomes, including wound healing time, recurrence rate, postoperative pain, and faecal continence, will be evaluated and compared with the LIFT group during scheduled follow-up visits.
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A surgical approach involving placement of a seton through the fistula tract followed by fistulotomy (laying open of the tract) as definitive management for perianal fistula.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Fecal Continence Preservation
Časové okno: 12 weeks
|
12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Wound Healing Time
Časové okno: 12 weeks
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12 weeks
|
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Recurrence Rate
Časové okno: 12 weeks
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12 weeks
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CRS-2024-135-7
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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