Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580366
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Comparing Sennosid AB and Sodium PicosulfateMagnesium OxideCitric Acid for Bowel Preparation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sennosid AB Versus Sodium PicosulfateMagnesium OxideCitric Acid for Bowel Preparation A Prospective Randomized Observer-Blinded Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Colonoscopy Preparation Comparing Sennoside AB and PMCa
Colonoscopy is a test used to examine the inside of the bowel Proper bowel preparation is crucial because it helps doctors get a clear view during the procedure
What is Sennoside AB Sennoside AB is a type of laxative made from the senna plant It works by stimulating the bowel to move and reducing the absorption of water making it easier to pass stools Research has shown that high doses of sennoside AB can be effective for bowel preparation
Sennoside AB vs PEG
Some studies have found that sennoside AB is more effective than PEG another laxative but can cause more abdominal pain Other studies have found no significant difference in effectiveness between the two
What is PicosulfateMagnesium OxideCitric Acid PMCa PMCa is a combination of sodium picosulfate magnesium oxide and citric acid Sodium picosulfate stimulates bowel movements while magnesium oxide and citric acid help increase water in the bowel making it easier to pass stools
PMCa vs PEG
Research has shown that PMCa is as effective as PEG for bowel preparation Patients using PMCa generally tolerate the preparation process better than those using PEG
Conclusion
While PEG is the preferred option according to guidelines its high cost can make it less accessible in some places In this study we aim to compare the effectiveness and patient tolerance of Sennoside AB and PMCa since no direct comparison between these two preparations has been made before
Colonoscopy is a test used to examine the inside of the bowel Proper bowel preparation is crucial because it helps doctors get a clear view during the procedure
What is Sennoside AB Sennoside AB is a type of laxative made from the senna plant It works by stimulating the bowel to move and reducing the absorption of water making it easier to pass stools Research has shown that high doses of sennoside AB can be effective for bowel preparation
Sennoside AB vs PEG
Some studies have found that sennoside AB is more effective than PEG another laxative but can cause more abdominal pain Other studies have found no significant difference in effectiveness between the two
What is PicosulfateMagnesium OxideCitric Acid PMCa PMCa is a combination of sodium picosulfate magnesium oxide and citric acid Sodium picosulfate stimulates bowel movements while magnesium oxide and citric acid help increase water in the bowel making it easier to pass stools
PMCa vs PEG
Research has shown that PMCa is as effective as PEG for bowel preparation Patients using PMCa generally tolerate the preparation process better than those using PEG
Conclusion
While PEG is the preferred option according to guidelines its high cost can make it less accessible in some places In this study we aim to compare the effectiveness and patient tolerance of Sennoside AB and PMCa since no direct comparison between these two preparations has been made before
Detailed Description:
Colonoscopy is an endoscopic imaging method used to examine the lumen and mucosa of the bowel It is the gold standard method used for colorectal cancer screening and the detection of most colorectal pathologies Successful bowel preparation is one of the key factors for a successful colonoscopic examination
Sennoside AB is a stimulant laxative derived from the senna plant Cassia senna Studies have shown that after senna is ingested it is activated by the gut flora directly interacts with the intestinal mucosa stimulates bowel movements and inhibits the absorption of electrolytes and water High doses of senna have been shown to be beneficial as a bowel preparation agent
There are many studies in the literature comparing senna compounds with polyethylene glycol PEG solutions In a randomized controlled study conducted by Coskun et al on 474 patients it was found that bowel cleansing was better with sennoside AB compared to PEG but abdominal pain was more common in the senna group Another randomized controlled study conducted by Shavakhi et al on 322 patients found no difference in effectiveness between the two agents
Drugs containing sodium picosulfate-magnesium oxide-citric acid PMCa are laxative agents recommended for colonoscopy preparation in ESGE and ASGE guidelines While sodium picosulfate acts as a stimulant laxative magnesium oxide and citric acid act as osmotic laxatives
In the SEE CLEAR II randomized controlled trial comparing PMCa with PEG PMCa was found to be as effective as PEG No significant difference was found between the two groups in terms of side effects but participants using PMCa tolerated the bowel preparation procedure much better
The ASGE and ESGE guidelines primarily recommend PEG solutions for colon preparation However due to the lack of reimbursement by the Social Security Institution SGK in our country and the resulting cost access to PEG treatment is difficult for patients For these reasons other treatments recommended in the available guidelines are used more frequently in our country
Although there are many studies in the literature comparing PMCa and sennoside AB preparations with PEG and other preparations in terms of efficacy for bowel preparation no study has directly compared PMCa with sennoside AB to date We aimed to compare the efficacy and patient tolerance of these two commonly used preparations in our country
Sennoside AB is a stimulant laxative derived from the senna plant Cassia senna Studies have shown that after senna is ingested it is activated by the gut flora directly interacts with the intestinal mucosa stimulates bowel movements and inhibits the absorption of electrolytes and water High doses of senna have been shown to be beneficial as a bowel preparation agent
There are many studies in the literature comparing senna compounds with polyethylene glycol PEG solutions In a randomized controlled study conducted by Coskun et al on 474 patients it was found that bowel cleansing was better with sennoside AB compared to PEG but abdominal pain was more common in the senna group Another randomized controlled study conducted by Shavakhi et al on 322 patients found no difference in effectiveness between the two agents
Drugs containing sodium picosulfate-magnesium oxide-citric acid PMCa are laxative agents recommended for colonoscopy preparation in ESGE and ASGE guidelines While sodium picosulfate acts as a stimulant laxative magnesium oxide and citric acid act as osmotic laxatives
In the SEE CLEAR II randomized controlled trial comparing PMCa with PEG PMCa was found to be as effective as PEG No significant difference was found between the two groups in terms of side effects but participants using PMCa tolerated the bowel preparation procedure much better
The ASGE and ESGE guidelines primarily recommend PEG solutions for colon preparation However due to the lack of reimbursement by the Social Security Institution SGK in our country and the resulting cost access to PEG treatment is difficult for patients For these reasons other treatments recommended in the available guidelines are used more frequently in our country
Although there are many studies in the literature comparing PMCa and sennoside AB preparations with PEG and other preparations in terms of efficacy for bowel preparation no study has directly compared PMCa with sennoside AB to date We aimed to compare the efficacy and patient tolerance of these two commonly used preparations in our country
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