search
Back to results

Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-YF in Treatment of Chronic Anal Fissure(CAF) (CAF)

Primary Purpose

Chronic Anal Fissure

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group I: Conventional Lateral internal sphincterotomy:
GroupII: V-Y advancement flap
GroupIII: Tailored LIS with V-Y advancement flap
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Anal Fissure focused on measuring Anal fissure, Advancement flap, Internal sphincterotomy

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • consecutive patients who treated for chronic anal fissure at colorectal surgery unite of Mansoura university hospital, Mansoura, Egypt.
  • all patients were selected to have increased resting anal pressure above the upper limit of normal range.

Exclusion Criteria:

  • patients with acute fissure
  • patients who had resting anal pressure within the normal range or less than the normal
  • cicatricial deformation
  • large sentinel pile
  • inflammatory bowel disease hemorrhoids
  • fistula in ano and anal abscesses
  • those who had undergone previous surgical procedure in the anal canal
  • age above 80 years
  • vascular disease
  • scleroderma
  • malnutrition
  • coagulopathy

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

CLI sphincterotomy

GroupII: V-Y advancement flap

TLIS with VY anoplasty

Arm Description

Conventional Lateral internal sphincterotomy LIS was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy to the level of the dentate line. Figures 5, 6, 7 and 8 illustrate the procedure.

The V-Y advancement flap was performed by making a V-shaped incision from the edges of the fissure extending about 4 cm from the anal verge and away from the midline. The V-shaped flap formed of skin and subcutaneous fat was mobilized sufficiently to allow advancement into the anal canal to cover the fissure defect. Care was taken to preserve enough pedicles to ensure adequate blood supply. The base of flap was sutured to the lower anal mucosa with interrupted 000 Vicryl Rapide. Figures 1, 2, 3 and 4 illustrate the procedure.

Tailored lateral sphincterotomy was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy, the extent of sphincterotomy was done to be more or less equal to the length of the fissure. Then the V-Y advancement flap was performed.

Outcomes

Primary Outcome Measures

complete healing (complete epithelization scare or no sign of fissure, healing was considered to be delayed if the wound had not completely healed by 6 weeks after the procedure).
complete healing (complete epithelization scare or no sign of fissure, healing was considered to be delayed if the wound had not completely healed by 6 weeks after the procedure).

Secondary Outcome Measures

Secondary outcomes were operative time
Secondary outcomes were operative time, length of hospital stay, anal incontinence (determined by Pescatori scoring system (32), time of relieve of pain, postoperative anal manometery, complications (eccyhmosis, haematoma, infection, disruption of flap, flap necrosis), persistent symptoms, patients satisfaction ( assessed on a visual analogue scale VAS), recurrence rate and quality of life.
length of hospital stay
early postoperative hospital stay
anal incontenance
using pescatori scoring
recurrence rate
recurrence rate
postoperative anal manometery
resting anal pressure
complication
necrosis, infection

Full Information

First Posted
December 15, 2011
Last Updated
December 23, 2011
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT01500889
Brief Title
Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-YF in Treatment of Chronic Anal Fissure(CAF)
Acronym
CAF
Official Title
Comparative Study of Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-Y Anoplasty in Treatment of Chronic Anal Fissure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators compared conventional lateral internal sphincterotomy (CLIS), V-Y anal flap, and combined tailored lateral internal sphincterotomy with V-Y anal flap (TLIS with V-YF) in a randomized prospective study in patients undergoing treatment for chronic anal fissure.
Detailed Description
Group I: Conventional Lateral internal sphincterotomy: LIS was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy to the level of the dentate line. Figures 5, 6, 7 and 8 illustrate the procedure. GroupII: V-Y advancement flap: The V-Y advancement flap was performed by making a V-shaped incision from the edges of the fissure extending about 4 cm from the anal verge and away from the midline. The V-shaped flap formed of skin and subcutaneous fat was mobilized sufficiently to allow advancement into the anal canal to cover the fissure defect. Care was taken to preserve enough pedicles to ensure adequate blood supply. The base of flap was sutured to the lower anal mucosa with interrupted 000 Vicryl Rapide. Figures 1, 2, 3 and 4 illustrate the procedure. GroupIII: Tailored lateral internal sphincterotomy with V-Y advancement flap: Tailored lateral sphincterotomy was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy, the extent of sphincterotomy was done to be more or less equal to the length of the fissure. Then the V-Y advancement flap was performed All assessments were conducted by investigators who were blinded to the experimental condition. The primary outcome was complete healing (complete epithelization scare or no sign of fissure, healing was considered to be delayed if the wound had not completely healed by 6 weeks after the procedure). Secondary outcomes were operative time, length of hospital stay, anal incontinence (determined by Pescatori scoring system (32), time of relieve of pain, postoperative anal manometery, complications (eccyhmosis, haematoma, infection, disruption of flap, flap necrosis), persistent symptoms, patients satisfaction ( assessed on a visual analogue scale VAS), recurrence rate and quality of life. Quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) developed by Eypasch and coworkers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Anal Fissure
Keywords
Anal fissure, Advancement flap, Internal sphincterotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CLI sphincterotomy
Arm Type
Active Comparator
Arm Description
Conventional Lateral internal sphincterotomy LIS was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy to the level of the dentate line. Figures 5, 6, 7 and 8 illustrate the procedure.
Arm Title
GroupII: V-Y advancement flap
Arm Type
Active Comparator
Arm Description
The V-Y advancement flap was performed by making a V-shaped incision from the edges of the fissure extending about 4 cm from the anal verge and away from the midline. The V-shaped flap formed of skin and subcutaneous fat was mobilized sufficiently to allow advancement into the anal canal to cover the fissure defect. Care was taken to preserve enough pedicles to ensure adequate blood supply. The base of flap was sutured to the lower anal mucosa with interrupted 000 Vicryl Rapide. Figures 1, 2, 3 and 4 illustrate the procedure.
Arm Title
TLIS with VY anoplasty
Arm Type
Active Comparator
Arm Description
Tailored lateral sphincterotomy was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy, the extent of sphincterotomy was done to be more or less equal to the length of the fissure. Then the V-Y advancement flap was performed.
Intervention Type
Procedure
Intervention Name(s)
Group I: Conventional Lateral internal sphincterotomy:
Other Intervention Name(s)
Group 1
Intervention Description
LIS was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy to the level of the dentate line. Figures 5, 6, 7 and 8 illustrate the procedure.
Intervention Type
Procedure
Intervention Name(s)
GroupII: V-Y advancement flap
Other Intervention Name(s)
Group 11
Intervention Description
GroupII: V-Y advancement flap: The V-Y advancement flap was performed by making a V-shaped incision from the edges of the fissure extending about 4 cm from the anal verge and away from the midline. The V-shaped flap formed of skin and subcutaneous fat was mobilized sufficiently to allow advancement into the anal canal to cover the fissure defect. Care was taken to preserve enough pedicles to ensure adequate blood supply. The base of flap was sutured to the lower anal mucosa with interrupted 000 Vicryl Rapide.
Intervention Type
Procedure
Intervention Name(s)
GroupIII: Tailored LIS with V-Y advancement flap
Other Intervention Name(s)
Group III
Intervention Description
Tailored lateral sphincterotomy was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy, the extent of sphincterotomy was done to be more or less equal to the length of the fissure. Then the V-Y advancement flap was performed.
Primary Outcome Measure Information:
Title
complete healing (complete epithelization scare or no sign of fissure, healing was considered to be delayed if the wound had not completely healed by 6 weeks after the procedure).
Description
complete healing (complete epithelization scare or no sign of fissure, healing was considered to be delayed if the wound had not completely healed by 6 weeks after the procedure).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Secondary outcomes were operative time
Description
Secondary outcomes were operative time, length of hospital stay, anal incontinence (determined by Pescatori scoring system (32), time of relieve of pain, postoperative anal manometery, complications (eccyhmosis, haematoma, infection, disruption of flap, flap necrosis), persistent symptoms, patients satisfaction ( assessed on a visual analogue scale VAS), recurrence rate and quality of life.
Time Frame
1 year
Title
length of hospital stay
Description
early postoperative hospital stay
Time Frame
one month
Title
anal incontenance
Description
using pescatori scoring
Time Frame
one year
Title
recurrence rate
Description
recurrence rate
Time Frame
one year
Title
postoperative anal manometery
Description
resting anal pressure
Time Frame
one year
Title
complication
Description
necrosis, infection
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: consecutive patients who treated for chronic anal fissure at colorectal surgery unite of Mansoura university hospital, Mansoura, Egypt. all patients were selected to have increased resting anal pressure above the upper limit of normal range. Exclusion Criteria: patients with acute fissure patients who had resting anal pressure within the normal range or less than the normal cicatricial deformation large sentinel pile inflammatory bowel disease hemorrhoids fistula in ano and anal abscesses those who had undergone previous surgical procedure in the anal canal age above 80 years vascular disease scleroderma malnutrition coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alae magdy, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
9407982
Citation
Littlejohn DR, Newstead GL. Tailored lateral sphincterotomy for anal fissure. Dis Colon Rectum. 1997 Dec;40(12):1439-42. doi: 10.1007/BF02070709.
Results Reference
result
PubMed Identifier
20177691
Citation
Chambers W, Sajal R, Dixon A. V-Y advancement flap as first-line treatment for all chronic anal fissures. Int J Colorectal Dis. 2010 May;25(5):645-8. doi: 10.1007/s00384-010-0881-1. Epub 2010 Feb 23.
Results Reference
result
PubMed Identifier
19225835
Citation
Giordano P, Gravante G, Grondona P, Ruggiero B, Porrett T, Lunniss PJ. Simple cutaneous advancement flap anoplasty for resistant chronic anal fissure: a prospective study. World J Surg. 2009 May;33(5):1058-63. doi: 10.1007/s00268-009-9937-1.
Results Reference
result
PubMed Identifier
20940607
Citation
Hancke E, Rikas E, Suchan K, Volke K. Dermal flap coverage for chronic anal fissure: lower incidence of anal incontinence compared to lateral internal sphincterotomy after long-term follow-up. Dis Colon Rectum. 2010 Nov;53(11):1563-8. doi: 10.1007/DCR.0b013e3181f0869f.
Results Reference
result
Links:
URL
http://www.mans.edu.eg
Description
Mansoura University

Learn more about this trial

Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-YF in Treatment of Chronic Anal Fissure(CAF)

We'll reach out to this number within 24 hrs