Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy Technique

Anal Fissure Clinical Trial

Official title:

Sungurtekin Technique vs. Closed Lateral Internal Sphincterotomy for Chronic Fissure-in-Ano: A Prospective, Randomized, Controlled Trial of a New Technique

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04428697
• Other study ID #: Sungurtekin 01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: August 1, 2020

Study information

• Verified date: June 2020
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Fissure
• Fissure in Ano

Intervention

Procedure:
• Sungurtekin Technique
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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

References & Publications (25)

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- — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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( — View Citation

García-Granero E, Sanahuja A, García-Armengol J, Jiménez E, Esclapez P, Mínguez M, Espí A, López F, Lledó S. Anal endosonographic evaluation after closed lateral subcutaneous sphincterotomy. Dis Colon Rectum. 1998 May;41(5):598-601. — View Citation

García-Granero E, Sanahuja A, García-Botello SA, Faiz O, Esclápez P, Espí A, Flor B, Minguez M, Lledó S. The ideal lateral internal sphincterotomy: clinical and endosonographic evaluation following open and closed internal anal sphincterotomy. Colorectal — View 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. Review. — View 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. — View 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 M — View Citation

Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. Review. — View 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. — View 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. — View 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/JC — View Citation

Mentes BB, Güner MK, Leventoglu S, Akyürek 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. Epub 2007 Dec 18. — View 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 — View 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. — View 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. — View 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. — View 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. Epub 2003 Sep 9. — View 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. — View 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. Epub 2004 May 6. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-24 month
Primary	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.	Postopetaive 3th day
Primary	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.	12th month
Primary	Complications	Urinary retansion,ecchymosis,itching,bleeding,abscess,fistula has been accepted as postoperative complications	1-24 month

External Links

•   Partly presented at this meeting