search
Back to results

Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy Technique

Primary Purpose

Anal Fissure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sungurtekin Technique
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anal Fissure focused on measuring Fissure-in-ano, Sphincterotomy, İncontinence, Surgical technique

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with CAFs that had failed conservative therapy and required surgical treatment

-

Exclusion Criteria:

  • Patients who have a low resting anal pressure in manometric study (lower than 40 mmHg)
  • Recurrent anal fissure
  • Fissure location other than the posterior anal canal
  • Fissure due to inflammatory bowel or infectious disease
  • Acute anal fissure,
  • Fissure due to chronic diarrhea or anal stenosis
  • Anorectal malignancy
  • Patients undergone pelvic radiotherapy
  • Pregnancy
  • Patients with history of diabetes, neurological disease and spinal cord lesions
  • Previous episiotomy history
  • Painless fissures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sungurtekin Technique

    Closed Lateral Internal Sphincterotomy

    Arm Description

    Sungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm. After identifying both the internal and external sphincters completely, under direct vision, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. This section was preserved during the operation in a standard fashion for all patients . Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter bundle was elevated with a right angle clamp, then cut with cautery . The operation was completed with meticulous hemostasis and additional suturing (3/0 absorbable suture) of the proximally dissected mucosal flap underlying the muscularis layer

    The sphincterotomy was performed through a new incision, guided by the surgeon's finger, as described by Boulos et al Boulos PB, Araujo JG. Adequate internal sphincterotomy for chronic anal fissure: subcutaneous or open technique? The British journal of surgery 1984;71:360-2.

    Outcomes

    Primary Outcome Measures

    Recurrence
    It has been reported in the literature that healing was completed in 6-8 weeks in patients undergoing this operation. During this period, it was accepted that the fissure was no longer detected as a visual examination finding and that patient complaints disappeared.
    Postoperatif pain
    The patients asked to record postoperative pain scores with VAS(Visual Analog Scale)Graded from 0.0 to 10.0. and measured postoperative day 3 .As low as possible this pain score value indicates that the patient is exposed to less pain.
    Incontinence Rate
    Pre and postoperative fecal continence were scored using the Cleveland Clinic Florida Fecal Incontinence (CCF-FI) scores. Cleveland Clinic Florida (CCF) scores were used to assess the severity of fecal incontinence at baseline, and at 12 months. The scores from 0 indicate perfect continence to a maximum of 20 indicates complete incontinence The CCF FI scale combines loss of flatus, liquid and solid stool, use of a pad and the impact on the quality of life a assess the severity of fecal incontinence.
    Complications
    Urinary retansion,ecchymosis,itching,bleeding,abscess,fistula has been accepted as postoperative complications

    Secondary Outcome Measures

    Full Information

    First Posted
    May 22, 2020
    Last Updated
    June 10, 2020
    Sponsor
    Pamukkale University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04428697
    Brief Title
    Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy Technique
    Official Title
    Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy for Chronic Fissure-in-Ano: A Prospective, Randomized, Controlled Trial of a New Technique
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2013 (Actual)
    Primary Completion Date
    May 1, 2020 (Actual)
    Study Completion Date
    August 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pamukkale University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    BACKGROUND: Currently, the lateral internal sphincterotomy is the treatment of choice for a chronic anal fissure. However, the length of the internal sphincter incision varies, due to lack of standardization. Insufficient length increases the risk of recurrence. OBJECTIVE: To compare a new ultra-modified internal sphincterotomy technique to the closed lateral sphincterotomy for treating chronic anal fissures, based on internal anal sphincter function and postoperative complications. DESIGN: Prospective, randomized, controlled trial (block randomization method) SETTING: Pamukkale University hospital in Denizli-Turkey PARTICIPANTS: 200 patients with chronic anal fissures INTERVENTION: Patients were randomly assigned to receive either Sungurtekin technique (n = 100; ultra-modified group), or the closed lateral internal sphincterotomy (n = 100; closed-lateral group). Follow-up was 2 years. MAIN OUTCOME MEASURES: The primary outcome was chronic anal fissure healing. The secondary outcomes were complications, visual analog scale pain scores, sphincter pressures, and incontinence scores.
    Detailed Description
    Although the lateral internal sphincterotomy is the treatment of choice for CAF, it has several drawbacks. First, the lower portion of the internal sphincter is nested in the lowermost part of the anus. Thus, an incision from the fissure base up to the dentate line removes support to the inner sphincter structure on the incision site. In our opinion; this is the main cause of different levels of incontinence developing in the postoperative period. Second, the internal sphincter muscle is shorter in women than in men. Therefore, women are at higher risk of postoperative anal incontinence than men. Third, because the lateral internal sphincterotomy is not standardized, the length of the internal sphincter incision varies, depending on the surgeon's discretion and competency. Fourth, an incision that is too short increases in the risk of recurrence. The investigators believe that this observation could be explained by the fact that the length of the incision required for a lateral internal sphincterotomy procedure has not been standardized

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anal Fissure
    Keywords
    Fissure-in-ano, Sphincterotomy, İncontinence, Surgical technique

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Outcome Assessor doesn't know the type of the surgery.
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sungurtekin Technique
    Arm Type
    Experimental
    Arm Description
    Sungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm. After identifying both the internal and external sphincters completely, under direct vision, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. This section was preserved during the operation in a standard fashion for all patients . Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter bundle was elevated with a right angle clamp, then cut with cautery . The operation was completed with meticulous hemostasis and additional suturing (3/0 absorbable suture) of the proximally dissected mucosal flap underlying the muscularis layer
    Arm Title
    Closed Lateral Internal Sphincterotomy
    Arm Type
    Active Comparator
    Arm Description
    The sphincterotomy was performed through a new incision, guided by the surgeon's finger, as described by Boulos et al Boulos PB, Araujo JG. Adequate internal sphincterotomy for chronic anal fissure: subcutaneous or open technique? The British journal of surgery 1984;71:360-2.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sungurtekin Technique
    Intervention Description
    Sungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter cut with cautery .
    Primary Outcome Measure Information:
    Title
    Recurrence
    Description
    It has been reported in the literature that healing was completed in 6-8 weeks in patients undergoing this operation. During this period, it was accepted that the fissure was no longer detected as a visual examination finding and that patient complaints disappeared.
    Time Frame
    1-24 month
    Title
    Postoperatif pain
    Description
    The patients asked to record postoperative pain scores with VAS(Visual Analog Scale)Graded from 0.0 to 10.0. and measured postoperative day 3 .As low as possible this pain score value indicates that the patient is exposed to less pain.
    Time Frame
    Postopetaive 3th day
    Title
    Incontinence Rate
    Description
    Pre and postoperative fecal continence were scored using the Cleveland Clinic Florida Fecal Incontinence (CCF-FI) scores. Cleveland Clinic Florida (CCF) scores were used to assess the severity of fecal incontinence at baseline, and at 12 months. The scores from 0 indicate perfect continence to a maximum of 20 indicates complete incontinence The CCF FI scale combines loss of flatus, liquid and solid stool, use of a pad and the impact on the quality of life a assess the severity of fecal incontinence.
    Time Frame
    12th month
    Title
    Complications
    Description
    Urinary retansion,ecchymosis,itching,bleeding,abscess,fistula has been accepted as postoperative complications
    Time Frame
    1-24 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with CAFs that had failed conservative therapy and required surgical treatment - Exclusion Criteria: Patients who have a low resting anal pressure in manometric study (lower than 40 mmHg) Recurrent anal fissure Fissure location other than the posterior anal canal Fissure due to inflammatory bowel or infectious disease Acute anal fissure, Fissure due to chronic diarrhea or anal stenosis Anorectal malignancy Patients undergone pelvic radiotherapy Pregnancy Patients with history of diabetes, neurological disease and spinal cord lesions Previous episiotomy history Painless fissures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ugur Sungurtekin, MD
    Organizational Affiliation
    Pamukkale University Department Of Surgery,Colorectal Surgery Division
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    13680282
    Citation
    Tocchi A, Mazzoni G, Miccini M, Cassini D, Bettelli E, Brozzetti S. Total lateral sphincterotomy for anal fissure. Int J Colorectal Dis. 2004 May;19(3):245-9. doi: 10.1007/s00384-003-0525-9. Epub 2003 Sep 9.
    Results Reference
    result
    PubMed Identifier
    25585082
    Citation
    Gandomkar H, Zeinoddini A, Heidari R, Amoli HA. Partial lateral internal sphincterotomy versus combined botulinum toxin A injection and topical diltiazem in the treatment of chronic anal fissure: a randomized clinical trial. Dis Colon Rectum. 2015 Feb;58(2):228-34. doi: 10.1097/DCR.0000000000000307.
    Results Reference
    result
    PubMed Identifier
    28239456
    Citation
    Salih AM. Chronic anal fissures: Open lateral internal sphincterotomy result; a case series study. Ann Med Surg (Lond). 2017 Feb 14;15:56-58. doi: 10.1016/j.amsu.2017.02.005. eCollection 2017 Mar.
    Results Reference
    result
    PubMed Identifier
    26231724
    Citation
    Liang J, Church JM. Lateral internal sphincterotomy for surgically recurrent chronic anal fissure. Am J Surg. 2015 Oct;210(4):715-9. doi: 10.1016/j.amjsurg.2015.05.005. Epub 2015 Jun 27.
    Results Reference
    result
    PubMed Identifier
    15129311
    Citation
    Wiley M, Day P, Rieger N, Stephens J, Moore J. Open vs. closed lateral internal sphincterotomy for idiopathic fissure-in-ano: a prospective, randomized, controlled trial. Dis Colon Rectum. 2004 Jun;47(6):847-52. doi: 10.1007/s10350-004-0530-2. Epub 2004 May 6.
    Results Reference
    result
    PubMed Identifier
    24637183
    Citation
    Gupta V, Rodrigues G, Prabhu R, Ravi C. Open versus closed lateral internal anal sphincterotomy in the management of chronic anal fissures: a prospective randomized study. Asian J Surg. 2014 Oct;37(4):178-83. doi: 10.1016/j.asjsur.2014.01.009. Epub 2014 Mar 14.
    Results Reference
    result
    PubMed Identifier
    29779044
    Citation
    Alawady M, Emile SH, Abdelnaby M, Elbanna H, Farid M. Posterolateral versus lateral internal anal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. Int J Colorectal Dis. 2018 Oct;33(10):1461-1467. doi: 10.1007/s00384-018-3087-6. Epub 2018 May 19.
    Results Reference
    result
    PubMed Identifier
    18085337
    Citation
    Mentes BB, Guner MK, Leventoglu S, Akyurek N. Fine-tuning of the extent of lateral internal sphincterotomy: spasm-controlled vs. up to the fissure apex. Dis Colon Rectum. 2008 Jan;51(1):128-33. doi: 10.1007/s10350-007-9121-3. Epub 2007 Dec 18.
    Results Reference
    result
    PubMed Identifier
    23575405
    Citation
    Murad-Regadas SM, Fernandes GO, Regadas FS, Rodrigues LV, Pereira Jde J, Regadas Filho FS, Dealcanfreitas ID, Holanda Ede C. How much of the internal sphincter may be divided during lateral sphincterotomy for chronic anal fissure in women? Morphologic and functional evaluation after sphincterotomy. Dis Colon Rectum. 2013 May;56(5):645-51. doi: 10.1097/DCR.0b013e31827a7416.
    Results Reference
    result
    PubMed Identifier
    31552509
    Citation
    Tsunoda A, Takahashi T, Kusanagi H. Fissurectomy with vertical non-full-thickness sphincterotomy for chronic anal fissure. Tech Coloproctol. 2019 Oct;23(10):1009-1013. doi: 10.1007/s10151-019-02087-7. Epub 2019 Sep 24. No abstract available.
    Results Reference
    result
    PubMed Identifier
    8416784
    Citation
    Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
    Results Reference
    result
    PubMed Identifier
    6722464
    Citation
    Boulos PB, Araujo JG. Adequate internal sphincterotomy for chronic anal fissure: subcutaneous or open technique? Br J Surg. 1984 May;71(5):360-2. doi: 10.1002/bjs.1800710517.
    Results Reference
    result
    PubMed Identifier
    27926552
    Citation
    Stewart DB Sr, Gaertner W, Glasgow S, Migaly J, Feingold D, Steele SR. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum. 2017 Jan;60(1):7-14. doi: 10.1097/DCR.0000000000000735. No abstract available.
    Results Reference
    result
    PubMed Identifier
    18954306
    Citation
    Cross KL, Massey EJ, Fowler AL, Monson JR; ACPGBI. The management of anal fissure: ACPGBI position statement. Colorectal Dis. 2008 Nov;10 Suppl 3:1-7. doi: 10.1111/j.1463-1318.2008.01681.x. No abstract available.
    Results Reference
    result
    PubMed Identifier
    28701263
    Citation
    Brady JT, Althans AR, Neupane R, Dosokey EMG, Jabir MA, Reynolds HL, Steele SR, Stein SL. Treatment for anal fissure: Is there a safe option? Am J Surg. 2017 Oct;214(4):623-628. doi: 10.1016/j.amjsurg.2017.06.004. Epub 2017 Jul 5.
    Results Reference
    result
    PubMed Identifier
    28274000
    Citation
    Manoharan R, Jacob T, Benjamin S, Kirishnan S. Lateral Anal Sphincterotomy for Chronic Anal Fissures- A Comparison of Outcomes and Complications under Local Anaesthesia Versus Spinal Anaesthesia. J Clin Diagn Res. 2017 Jan;11(1):PC08-PC12. doi: 10.7860/JCDR/2017/21779.9299. Epub 2017 Jan 1.
    Results Reference
    result
    PubMed Identifier
    18637925
    Citation
    Garcia-Granero E, Sanahuja A, Garcia-Botello SA, Faiz O, Esclapez P, Espi A, Flor B, Minguez M, Lledo S. The ideal lateral internal sphincterotomy: clinical and endosonographic evaluation following open and closed internal anal sphincterotomy. Colorectal Dis. 2009 Jun;11(5):502-7. doi: 10.1111/j.1463-1318.2008.01645.x. Epub 2008 Jul 15.
    Results Reference
    result
    PubMed Identifier
    9593242
    Citation
    Garcia-Granero E, Sanahuja A, Garcia-Armengol J, Jimenez E, Esclapez P, Minguez M, Espi A, Lopez F, Lledo S. Anal endosonographic evaluation after closed lateral subcutaneous sphincterotomy. Dis Colon Rectum. 1998 May;41(5):598-601. doi: 10.1007/BF02235266.
    Results Reference
    result
    PubMed Identifier
    15540293
    Citation
    Lindsey I, Jones OM, Smilgin-Humphreys MM, Cunningham C, Mortensen NJ. Patterns of fecal incontinence after anal surgery. Dis Colon Rectum. 2004 Oct;47(10):1643-9. doi: 10.1007/s10350-004-0651-7.
    Results Reference
    result
    PubMed Identifier
    17665247
    Citation
    Elsebae MM. A study of fecal incontinence in patients with chronic anal fissure: prospective, randomized, controlled trial of the extent of internal anal sphincter division during lateral sphincterotomy. World J Surg. 2007 Oct;31(10):2052-7. doi: 10.1007/s00268-007-9177-1.
    Results Reference
    result
    PubMed Identifier
    25101617
    Citation
    Ribas Y, Hotouras A, Munoz-Duyos A, Murphy J, Chan CL. Sphincterotomy in women with chronic anal fissure? Are we asking for trouble? Dis Colon Rectum. 2014 Sep;57(9):e404. doi: 10.1097/DCR.0000000000000184. No abstract available.
    Results Reference
    result
    PubMed Identifier
    23320551
    Citation
    Garg P, Garg M, Menon GR. Long-term continence disturbance after lateral internal sphincterotomy for chronic anal fissure: a systematic review and meta-analysis. Colorectal Dis. 2013 Mar;15(3):e104-17. doi: 10.1111/codi.12108.
    Results Reference
    result
    PubMed Identifier
    24241581
    Citation
    Davies I, Dafydd L, Davies L, Beynon J. Long term outcomes after lateral anal sphincterotomy for anal fissure: a retrospective cohort study. Surg Today. 2014 Jun;44(6):1032-9. doi: 10.1007/s00595-013-0785-0. Epub 2013 Nov 19.
    Results Reference
    result
    PubMed Identifier
    27004344
    Citation
    Ghayas N, Younus SM, Mirani AJ, Ghayasuddin M, Qazi A, Suchdev SD, Bakshi SK. FREQUENCY OF POST-OPERATIVE FAECAL INCONTINENCE IN PATIENTS WITH CLOSED AND OPEN INTERNAL ANAL SPHINCTEROTOMY. J Ayub Med Coll Abbottabad. 2015 Oct-Dec;27(4):878-82.
    Results Reference
    result
    PubMed Identifier
    15906136
    Citation
    Casillas S, Hull TL, Zutshi M, Trzcinski R, Bast JF, Xu M. Incontinence after a lateral internal sphincterotomy: are we underestimating it? Dis Colon Rectum. 2005 Jun;48(6):1193-9. doi: 10.1007/s10350-004-0914-3.
    Results Reference
    result

    Learn more about this trial

    Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy Technique

    We'll reach out to this number within 24 hrs