This Study Compares the Conventional Cutting Seton Technique and a GLUBRAN®-Coated Seton in High Perianal Fistula Treatment. The Study Aims to Determine Whether the GLUBRAN®-Coated Seton Improves Healing, Reduces Postoperative Pain and Recurrence, and Better Preserves Anal Continence.

NCT07676825 | Active Not Recruiting DMC

• 1 other identifier: MS-682-2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

High anal fistula is a complex anorectal condition that can cause persistent pain, purulent discharge, recurrent infection, and a significant reduction in quality of life. The conventional cutting seton technique is an established treatment modality; however, it may be associated with postoperative pain, delayed healing, recurrence, and impairment of anal continence. GLUBRAN® is a synthetic surgical adhesive with antimicrobial and tissue-healing properties that may enhance the performance of the cutting seton and improve clinical outcomes. This randomized controlled clinical trial aims to compare the efficacy and safety of a conventional cutting seton with a GLUBRAN®-coated cutting seton in adult patients with high anal fistulas. Eligible participants will be randomly allocated to one of the two treatment groups and followed for six months after surgery. The primary and secondary outcome measures will include fistula healing rate, time to complete healing, postoperative pain, anal continence, recurrence, postoperative complications, and length of hospital stay. The findings of this study may provide evidence regarding whether coating a cutting seton with GLUBRAN® offers clinical advantages over the conventional technique, potentially leading to improved healing, reduced postoperative morbidity, and better preservation of anal continence in the management of high anal fistulas.

Conditions

Perianal Fistula

Keywords

Fistula; High Fistula; Complex Fistula; Seton; Glubran

Outcome Measures

Primary Outcomes (2)

• Continence

  Assessment of continence status using a validated scoring system (e.g., Wexner Incontinence Score) to compare the impact of both techniques on sphincter function. (0 - 20) 0 being no incontinence, and 20 being no continence.

  6 months

• Healing Rate

  To compare the complete healing rate and time of complete healing after treatment using either Seton placement or GLUBRAN®-coated Seton over a standardized follow-up period of 6 months

  6 months

Secondary Outcomes (3)

• Hospital Stay Duration

  2 days

• Incidence of complications such as infection, abscess formation, bleeding.

  6 months

• Recurrence

  6 months

Study Arms (2)

Glubran-coated Seton

EXPERIMENTAL

Using Glubran combined with Seton in the managment of high/complex perianal fistula

Procedure: Glubran-coated Seton

Seton

ACTIVE COMPARATOR

Using regular Seton that is already established in the management of high/complex perianal fistula

Procedure: Seton

Interventions

Glubran-coated Seton PROCEDURE

Using 2 ampules of no. 1 Vicryl suture as a Seton combined with Glubran 2 in the management of high/complex perianal fistula

Glubran-coated Seton

Seton PROCEDURE

Using 2 ampules of no. 1 Vicryl as a regular Seton

Seton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients fit for surgery.

You may not qualify if:

• Patients with Crohn's disease, tuberculosis, malignancy, or radiation-associated fistulas (due to different healing patterns and management protocols).
• Presence of acute perianal abscess at the time of surgery
• Patients with uncontrolled comorbidities (e.g., diabetes mellitus, bleeding disorders, immunosuppression) that could affect healing.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al Ainy Hospital

Giza, Giza Governorate, 11562, Egypt

Location

Related Publications (6)

• Barillari P, Basso L, Larcinese A, Gozzo P, Indinnimeo M. Cyanoacrylate glue in the treatment of ano-rectal fistulas. Int J Colorectal Dis. 2006 Dec;21(8):791-4. doi: 10.1007/s00384-006-0090-0. Epub 2006 Apr 20.

  PMID: 16625375 BACKGROUND

• 8. Koli D, Kumar P, Panda V. "Evaluation of the role of cyanoacrylate glue in the management of fistula-in-ano." International Surgery Journal. 2020;7(9):3349-3353.

  BACKGROUND

• Garcia-Aguilar J, Belmonte C, Wong DW, Goldberg SM, Madoff RD. Cutting seton versus two-stage seton fistulotomy in the surgical management of high anal fistula. Br J Surg. 1998 Feb;85(2):243-5. doi: 10.1046/j.1365-2168.1998.02877.x.

  PMID: 9501826 BACKGROUND

• Parks AG, Gordon PH, Hardcastle JD. A classification of fistula-in-ano. Br J Surg. 1976 Jan;63(1):1-12. doi: 10.1002/bjs.1800630102.

  PMID: 1267867 BACKGROUND

• Shirah BH, Shirah HA. The Impact of the Outcome of Treating a High Anal Fistula by Using a Cutting Seton and Staged Fistulotomy on Saudi Arabian Patients. Ann Coloproctol. 2018 Oct;34(5):234-240. doi: 10.3393/ac.2018.03.23. Epub 2018 Oct 10.

  PMID: 30304930 BACKGROUND

• 1. Treatment of fistula-in-ano with tight (cutting) seton: analysis of outcomes and efficacy assessment. Al-Marzooq TJM, Hassan QA, Alnaser MKH, Al-edani MS. J Clin Diagn Res. 2017;11:5-8

  BACKGROUND

Related Links

• This paper is a clinical surgical study focused on the management of high transsphincteric anal fistula, a complex anorectal condition that involves an abnormal tract passing through the anal sphincter muscles.

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ismail A Shafik, M.D.

  Kasr El Aini Hospital

  STUDY CHAIR

• Abdelrahman M. Ibrahim, M.D.

  Kasr El Aini Hospital

  STUDY DIRECTOR

• Ahmed Y. Ahmed, M.D.

  Kasr El Aini Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Resident

Model Details: articipants diagnosed with high anal fistula and meeting the eligibility criteria will be randomly assigned in a 1:1 ratio to one of two parallel study groups. Randomization will be performed using a computer-generated random allocation sequence with concealed allocation. Group A (Control Group) will undergo conventional cutting seton placement using a silk seton. Group B (Intervention Group) will undergo cutting seton placement using a silk seton coated with GLUBRAN® surgical adhesive prior to insertion. All surgical procedures will be performed according to standardized operative techniques, and all participants will receive the same postoperative care and follow-up schedule. Participants will be evaluated during the postoperative period and at regular follow-up visits to assess healing, continence, pain, recurrence, and complications. The primary outcomes include complete healing rate, time to complete healing, and continence preservation as assessed by the Wexner Continence Score

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: January 11, 2026
• Primary Completion: July 11, 2026
• Study Completion: July 11, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)