Anoplasty in Treatment of Post Hemorroidectomy Anal StenosisNCT05389475
Anoplasty for Post Hemorroidectomy Anal Stenosis : Diamond Versus V-Y Flap Techniques
An observational study of Anoplasty in Treatment of Post Hemorroidectomy Anal Stenosis, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of the study to evaluate the outcome of diamond flap versus V-Y flap for treatment of severe post hemorroidectomy anal stenosis . Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anoplasty in Treatment of Post Hemorroidectomy Anal Stenosis
- What is being tested?
- anoplasty in treatment of post hemorroidectomy anal stenosis
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Based on determining the main outcome variable, the estimated minimum required sample size is 52cases (26in each group).
Who may be able to join
- Patients with post-surgical severe anal stenosis based on Milsom and Mazier classification after the failure of non-operative measures were included.
Who cannot join
- (1) Patients with functional stenosis as acute anal fissure. (2) Patients with a recent history of anal stenosis who had no medical treatment trial.
- Patients with mild or moderate anal stenosis who expected to respond to medical treatment.
- Patients with inflammatory bowel disease, tuberculosis, or perianal fistula.
- Patients with previous radiotherapy or previous anal malignancy. (6) Patients with previous anoplasty.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university
Asyut, 17777
Momen Shalqamy, PhD, 01017520093, Moamen.shalkamy@aun.edu.eg
About this study
The aim of the study to evaluate the outcome of diamond flap versus V-Y flap for treatment of severe post hemorroidectomy anal stenosis .
Read the detailed description
Anal stenosis is diagnosed when there is a narrowing of the anal canal and subsequent loss of normal elasticity that makes its wall rigid and unable to be dilated to permit normal pain-free defecation(1). The underlying pathology of anal stenosis results from a wide variety of either functional or anatomical causes . In functional anal stenosis, the presence of a hypertonic internal anal sphincter is the major cause of the narrowing, whereas in anatomical anal stenosis, the normal elastic anoderm replaced by an inelastic rigid fibrous tissue is the major cause of the anal canal narrowing(2). The best way of treatment of anal stenosis is avoiding its occurrence, as the major cause is following surgical hemorrhoidectomy, particularly when a large area of anoderm lining the anal canal is removed during the operation, but can also complicates other anorectal surgical operations(3). The patient usually experiences painful defecation, incomplete evacuation, pellet stool, or rectal bleeding. These manifestations force the patient to rely on daily laxatives or enemas in bowel evacuation(1). Usually physical examination is all that is needed to confirm the diagnosis of anal stenosis, including inspection of the anal canal, perianal skin, and digital rectal examination]. Anatomical anal stenosis can be classified according to Milsom and Mazie (4) based on the severity of the anal canal narrowing into mild anal stenosis, when the anal canal can be examined by a well-lubricated index finger or a medium-sized Hill-Ferguson retractor; moderate anal stenosis, when forceful dilatation is required to insert either the index finger or a medium-sized Hill-Ferguson retractor; and severe anal stenosis, when neither the little finger nor a small-sized Hill-Ferguson retractor can be inserted.
In most patients with mild to moderate anal stenosis, medical management with stool softeners or fiber supplements , emollient laxatives , high fiber diet to help softener of stool and make it pass easily would be a choice(5).
However, different surgical procedures are reserved for patients with severe anal stenosis and in case of failed medical treatment. The choice of the most appropriate procedure is based on the severity where lateral sphincterotomy could be sufficient for a patient with a mild and sometimes moderate degree of anal stenosis after failure of medical treatment(6). However, various flap anoplasty procedures should be reserved for the more severe cases to replace the cicatrized tissues The aim of various techniques of anoplasty is to restore the normal function of the narrowed anal canal by dividing the stricture, and this leads to widening of the anal canal while preserving the anal continence and thus pain-free bowel evacuation(7).
Prevention The best treatment for anal stenosis after hemorrhoidectomy is a meticulous approach in the operating room during the primary operation. The risk of anal stenosis increases with the complexity and extent of the hemorrhoids treated. Surgical therapy of extensive and complicated hemorrhoids should only be approached by surgeons experienced in this operation. The keys to prevention of anal stenosis after hemorrhoidectomy are meticulous submucosal dissection with avoidance of injury to the internal sphincter muscle and the preservation of sufficient intact anoderm between excision sites, generally considered at least 1 cm of intact intervening anoderm. Additionally, limiting the number of hemorrhoids excised in a given setting will also help to limit the incidence of postoperative stenosis. Nonoperative Intervention The cornerstone of therapy for anal stenosis from all causes is dietary modification, including a combination approach utilizing stool softeners as well as increased fiber intake and water consumption. For many patients with mild stenosis, these simple measures may alleviate the patient's symptoms. For patients not initially responsive to these measures, and those with moderate steno ses, it is reasonable to attempt a course of manual dilation in addition to the above measures. This program consists of an initial dilation in the operating room or clinic, if tolerated, followed by serial dilations at home by the patient using either a finger or a dilator. This can be facilitated and better tolerated through the use of anesthetic jelly (e.g., lidocaine 2%). The majority of patients with mild stenosis will achieve symptom alleviation with this approach, as will many patients with moderate stenosis. Manual dilation does have some risks, such as perforation, but these risks are low
Surgical methods in treatment of anal stenosis contain:
- Lateral Internal Sphincterotomy
- Lateral Mucosal Advancement Flap
- V-Y Advancement Flap
- Diamond-Shaped Flap
- House Flap
- U-shaped Flap
- Being tested
- anoplasty in treatment of post hemorroidectomy anal stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anoplasty in treatment of post hemorroidectomy anal stenosisProcedure or surgery
Diamond flap versus V-Y flap
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between outcomes of Diamond flap versus V-Y flap in treatment of anal stenosis post hemorroidectomy
Postoperative complication as anal pain , bleeding , infection , healing , incontinence
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anoplasty in Treatment of Post Hemorroidectomy Anal StenosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Mokbel, Assiut University
- Investigators
- Momen Shalqamy, PhD, Study director, Moamen.shalkamy@aun.edu.egGamal Abdelhamid, PhD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389475
- Sponsor's protocol ID
- Diamond flap
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1 Liberman H, Thorson AG. How I do it: anal stenosis. Am J Surg 2000; 179:325-329. 2 Casadesus D, Villasana LE, Diaz H, Chavez M, Sanchez IM, Martinez PP, et al. Treatment of anal stenosis: a 5-year review. ANZ J Surg 2007:557-559. 3 Caplin DA, Kodner IJ. Repair of anal stricture and mucosal ectropion by simple flap procedures. Dis Colon Rectum 1986; 29:92-94. 4 Milsom JW, Mazier WP. Classification and management of postsurgical anal stenosis. Surg Gynecol Obstet 1986; 163:60-64. 5 Corman ML, Bergamaschi RCM, Nicholls RJ, Turnbull FRBJr, editors. Corman's colon and rectal surgery. 6th ed. New York: Stony Brook University 2013. 327. 6 Owen HA, Edwards DP, Khosraviani K, Phillips RK. The house advancement anoplasty for treatment of anal disorders. J R Army Med Corps 2006; 152:87-88. 7 Duieb Z, Appu S, Hung K, Nguyen H. Anal stenosis: use of an algorithm to provide a tension-free anoplasty. ANZ J Surg 2010; 80:337-340. 778 The Egyptian Journal of Surgery, Vol. 39 No. 3, July-September 2020 [Downloaded free from http://www.ejs.eg.net on Sunday, October 10, 2021, IP: 197.36.13.202] 8 Maria G, Brisinda G, Civello IM. Anoplasty for the treatment of anal stenosis. Am J Surg 1998; 175:158-160 9 Brisinda G. How to treat hemorrhoids. Prevention is best; hemorrhoidectomy needs skilled operators. BMJ 2000; 321:582-583. 10 Shevchuk IM, Sadoviy IY, Novytskiy OV. Surgical treatment of postoperative stricture of anal channel. Klin Khir 2015; 9:20-22. 11 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; 33:1058-1063. 12 Abr-Gama A, Sobrado CW, Araujo SE, Nahas SC, Birbojm I, Nahas CS, et al. Surgical treatment of anal stenosis: assessment of 77 anoplasties. Clinics 2005; 60:17-20. 13 Nelson R. Operative procedure for fissure in ano. Cochrane Database Syst Rev 2005; 9:C D002199. 14 Carditello A, Milone A, Stilo F, Mollo F, Basile M. Surgical treatment of anal stenosis following hemorrhoid surgery. Results of 150 combined mucosal advancement and internal sphincterotomy. Chir Ital 2002; 54:841-844. 15 Brisinda G, Vanella S, Cadeddu F, Marniga G, Mazzeo P, Brandara F, Maria G. Surgical treatment of anal stenosis. World J Gastroenterol 2009; 15:1921-1928. 16 Aitola PT, Hiltunen KM, Matikainen MJ. Y-V anoplasty combined with internal sphincterotomy for stenosis of the anal canal. Eur J Surg 1997; 163:839-842
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anoplasty for Post Hemorroidectomy Anal Stenosis : Diamond Versus V-Y Flap Techniques
- ClinicalTrials.gov ID
- NCT05389475
- Acronym / sponsor ID
- Diamond flap
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study to evaluate the outcome of diamond flap versus V-Y flap for treatment of severe post hemorroidectomy anal stenosis .
Detailed description
Anal stenosis is diagnosed when there is a narrowing of the anal canal and subsequent loss of normal elasticity that makes its wall rigid and unable to be dilated to permit normal pain-free defecation(1). The underlying pathology of anal stenosis results from a wide variety of either functional or anatomical causes . In functional anal stenosis, the presence of a hypertonic internal anal sphincter is the major cause of the narrowing, whereas in anatomical anal stenosis, the normal elastic anoderm replaced by an inelastic rigid fibrous tissue is the major cause of the anal canal narrowing(2). The best way of treatment of anal stenosis is avoiding its occurrence, as the major cause is following surgical hemorrhoidectomy, particularly when a large area of anoderm lining the anal canal is removed during the operation, but can also complicates other anorectal surgical operations(3). The patient usually experiences painful defecation, incomplete evacuation, pellet stool, or rectal bleeding. These manifestations force the patient to rely on daily laxatives or enemas in bowel evacuation(1). Usually physical examination is all that is needed to confirm the diagnosis of anal stenosis, including inspection of the anal canal, perianal skin, and digital rectal examination]. Anatomical anal stenosis can be classified according to Milsom and Mazie (4) based on the severity of the anal canal narrowing into mild anal stenosis, when the anal canal can be examined by a well-lubricated index finger or a medium-sized Hill-Ferguson retractor; moderate anal stenosis, when forceful dilatation is required to insert either the index finger or a medium-sized Hill-Ferguson retractor; and severe anal stenosis, when neither the little finger nor a small-sized Hill-Ferguson retractor can be inserted.
In most patients with mild to moderate anal stenosis, medical management with stool softeners or fiber supplements , emollient laxatives , high fiber diet to help softener of stool and make it pass easily would be a choice(5).
However, different surgical procedures are reserved for patients with severe anal stenosis and in case of failed medical treatment. The choice of the most appropriate procedure is based on the severity where lateral sphincterotomy could be sufficient for a patient with a mild and sometimes moderate degree of anal stenosis after failure of medical treatment(6). However, various flap anoplasty procedures should be reserved for the more severe cases to replace the cicatrized tissues The aim of various techniques of anoplasty is to restore the normal function of the narrowed anal canal by dividing the stricture, and this leads to widening of the anal canal while preserving the anal continence and thus pain-free bowel evacuation(7).
Prevention The best treatment for anal stenosis after hemorrhoidectomy is a meticulous approach in the operating room during the primary operation. The risk of anal stenosis increases with the complexity and extent of the hemorrhoids treated. Surgical therapy of extensive and complicated hemorrhoids should only be approached by surgeons experienced in this operation. The keys to prevention of anal stenosis after hemorrhoidectomy are meticulous submucosal dissection with avoidance of injury to the internal sphincter muscle and the preservation of sufficient intact anoderm between excision sites, generally considered at least 1 cm of intact intervening anoderm. Additionally, limiting the number of hemorrhoids excised in a given setting will also help to limit the incidence of postoperative stenosis. Nonoperative Intervention The cornerstone of therapy for anal stenosis from all causes is dietary modification, including a combination approach utilizing stool softeners as well as increased fiber intake and water consumption. For many patients with mild stenosis, these simple measures may alleviate the patient's symptoms. For patients not initially responsive to these measures, and those with moderate steno ses, it is reasonable to attempt a course of manual dilation in addition to the above measures. This program consists of an initial dilation in the operating room or clinic, if tolerated, followed by serial dilations at home by the patient using either a finger or a dilator. This can be facilitated and better tolerated through the use of anesthetic jelly (e.g., lidocaine 2%). The majority of patients with mild stenosis will achieve symptom alleviation with this approach, as will many patients with moderate stenosis. Manual dilation does have some risks, such as perforation, but these risks are low
Surgical methods in treatment of anal stenosis contain:
- Lateral Internal Sphincterotomy
- Lateral Mucosal Advancement Flap
- V-Y Advancement Flap
- Diamond-Shaped Flap
- House Flap
- U-shaped Flap
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Based on determining the main outcome variable, the estimated minimum required sample size is 52cases (26in each group).
Key inclusion criteria (1 listed)
- Patients with post-surgical severe anal stenosis based on Milsom and Mazier classification after the failure of non-operative measures were included.
Key exclusion criteria (4 listed)
- (1) Patients with functional stenosis as acute anal fissure. (2) Patients with a recent history of anal stenosis who had no medical treatment trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anoplasty in treatment of post hemorroidectomy anal stenosisDiamond flap versus V-Y flap | Procedure or surgery | – |
Primary outcome
comparison between outcomes of Diamond flap versus V-Y flap in treatment of anal stenosis post hemorroidectomy
Time frame: 3 months
Postoperative complication as anal pain , bleeding , infection , healing , incontinence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background1 Liberman H, Thorson AG. How I do it: anal stenosis. Am J Surg 2000; 179:325-329. 2 Casadesus D, Villasana LE, Diaz H, Chavez M, Sanchez IM, Martinez PP, et al. Treatment of anal stenosis: a 5-year review. ANZ J Surg 2007:557-559. 3 Caplin DA, Kodner IJ. Repair of anal stricture and mucosal ectropion by simple flap procedures. Dis Colon Rectum 1986; 29:92-94. 4 Milsom JW, Mazier WP. Classification and management of postsurgical anal stenosis. Surg Gynecol Obstet 1986; 163:60-64. 5 Corman ML, Bergamaschi RCM, Nicholls RJ, Turnbull FRBJr, editors. Corman's colon and rectal surgery. 6th ed. New York: Stony Brook University 2013. 327. 6 Owen HA, Edwards DP, Khosraviani K, Phillips RK. The house advancement anoplasty for treatment of anal disorders. J R Army Med Corps 2006; 152:87-88. 7 Duieb Z, Appu S, Hung K, Nguyen H. Anal stenosis: use of an algorithm to provide a tension-free anoplasty. ANZ J Surg 2010; 80:337-340. 778 The Egyptian Journal of Surgery, Vol. 39 No. 3, July-September 2020 [Downloaded free from http://www.ejs.eg.net on Sunday, October 10, 2021, IP: 197.36.13.202] 8 Maria G, Brisinda G, Civello IM. Anoplasty for the treatment of anal stenosis. Am J Surg 1998; 175:158-160 9 Brisinda G. How to treat hemorrhoids. Prevention is best; hemorrhoidectomy needs skilled operators. BMJ 2000; 321:582-583. 10 Shevchuk IM, Sadoviy IY, Novytskiy OV. Surgical treatment of postoperative stricture of anal channel. Klin Khir 2015; 9:20-22. 11 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; 33:1058-1063. 12 Abr-Gama A, Sobrado CW, Araujo SE, Nahas SC, Birbojm I, Nahas CS, et al. Surgical treatment of anal stenosis: assessment of 77 anoplasties. Clinics 2005; 60:17-20. 13 Nelson R. Operative procedure for fissure in ano. Cochrane Database Syst Rev 2005; 9:C D002199. 14 Carditello A, Milone A, Stilo F, Mollo F, Basile M. Surgical treatment of anal stenosis following hemorrhoid surgery. Results of 150 combined mucosal advancement and internal sphincterotomy. Chir Ital 2002; 54:841-844. 15 Brisinda G, Vanella S, Cadeddu F, Marniga G, Mazzeo P, Brandara F, Maria G. Surgical treatment of anal stenosis. World J Gastroenterol 2009; 15:1921-1928. 16 Aitola PT, Hiltunen KM, Matikainen MJ. Y-V anoplasty combined with internal sphincterotomy for stenosis of the anal canal. Eur J Surg 1997; 163:839-842
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Momen Shalqamy, PhD study director
Moamen.shalkamy@aun.edu.eg
Gamal Abdelhamid, PhD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anoplasty in Treatment of Post Hemorroidectomy Anal Stenosis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Mohamed Mokbel, Master (01025104556, omarmokbel1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between outcomes of Diamond flap versus V-Y flap in treatment of anal stenosis post hemorroidectomy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.