Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617026
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Short-Term Outcome of Medical Vs Surgical Management Of Chronic Anal Fissure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Short-Term Outcome of Medical Vs Surgical Management Of Chronic Anal Fissure A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Several topical agents have been proposed for Chronic anal fissure CAF treatment with the common goal of increasing anodermal blood flow to promote healing but approaching the use of medical treatment in CAFs is not standardized yet Thus the present study aimed to compare the efficacy and safety of Sucralfate Emoflon the combination of azadirachtin and hyperforin HyperOil and the traditional surgical treatment lateral sphincterotomy in patients with CAFs
Detailed Description:
Several topical agents have been proposed for Chronic anal fissure CAF treatment with the common goal of increasing anodermal blood flow to promote healing but approaching the use of medical treatment in CAFs is not standardized yet Thus the present study aimed to compare the efficacy and safety of Sucralfate Emoflon the combination of azadirachtin and hyperforin HyperOil and the traditional surgical treatment lateral sphincterotomy in patients with CAFs
Study Objective
Primary Objectives
1 To evaluate the efficacy and safety of Sucralfate Emoflon the combination of azadirachtin and hyperforin HyperOil and the traditional surgical treatment lateral sphincterotomy in patients with CAFs
Study Design
A prospective randomized controlled trial
Study sampling
A convenience sampling method will be used all patients seeking medical advice for CAF at Suez Canal University hospitals the Faculty of Medicine during the study period and fulfill the inclusion criteria will be recruited One of the researchers who will make random allocation cards using an Excel formula algorithm will perform simple randomisation
Methodology
This study will include at least 99 patients with CAFs of both genders who will visit the general surgery clinic in the faculty of medicine at Suez Canal University hospital and fulfil the inclusion and exclusion starting from September 2024 Patients of both genders with CAF for the first time above 18 years old and ASA III will be included in the study While patients with sepsis previous pelvic radiation recurrent CAF with malignancy on immunosuppressive drugs with pregnancy or lactation will be excluded Patients will be randomly allocated into 3 groups at a ratio of 111 starting with the Sucralfate group Formal written consent will be obtained from the study participants prior to being involved in the study All included patients will be followed up to 40 days
Study Objective
Primary Objectives
1 To evaluate the efficacy and safety of Sucralfate Emoflon the combination of azadirachtin and hyperforin HyperOil and the traditional surgical treatment lateral sphincterotomy in patients with CAFs
Study Design
A prospective randomized controlled trial
Study sampling
A convenience sampling method will be used all patients seeking medical advice for CAF at Suez Canal University hospitals the Faculty of Medicine during the study period and fulfill the inclusion criteria will be recruited One of the researchers who will make random allocation cards using an Excel formula algorithm will perform simple randomisation
Methodology
This study will include at least 99 patients with CAFs of both genders who will visit the general surgery clinic in the faculty of medicine at Suez Canal University hospital and fulfil the inclusion and exclusion starting from September 2024 Patients of both genders with CAF for the first time above 18 years old and ASA III will be included in the study While patients with sepsis previous pelvic radiation recurrent CAF with malignancy on immunosuppressive drugs with pregnancy or lactation will be excluded Patients will be randomly allocated into 3 groups at a ratio of 111 starting with the Sucralfate group Formal written consent will be obtained from the study participants prior to being involved in the study All included patients will be followed up to 40 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None