Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294470
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2024-01-30
Brief Title:
Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome
Sponsor:
Universidad Central de Venezuela
Organization:
Universidad Central de Venezuela
Study Overview
Official Title:
Efficacy of the Hemorrhoidal Prolapse and Pexia Procedure for the Treatment of Defecatory Obstruction Syndrome
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to assess the efficiency of the procedure for hemorrhoidal prolapse and pexia in alleviating symptoms of defecatory obstruction among patients with grade II to IV mucohemorrhoidal prolapse
Detailed Description:
In 1998 Longo introduced a new technique called the stapled hemorrhoidal prolapse and pexia procedure PPH to treat mucohemorrhoidal disease According to Longo hemorrhoidal prolapse is always associated with internal rectal prolapse which can be a symptom of defecation obstruction syndrome The PPH technique aims to correct these symptoms by removing the mucosal segment and pexiing the hemorrhoids thus eliminating excess rectal tissue This improves the resting surface tension of the rectal mucosa making defecation easier and improving defecatory obstruction
The research focused on applying theoretical concepts related to defecatory obstruction secondary to mucohemorrhoidal prolapse which results in difficulties with an adequate defecatory act The main objective was to determine if surgery for hemorrhoidal prolapse and pexia could correct the symptoms of obstructed defecation as proposed by Longo The study established facilities to evaluate and provide pre- and postoperative follow-up to patients with symptoms of defecatory obstruction The research question posed was In patients with mucohemorrhoidal disease and symptoms of defecatory obstruction can the PPH technique improve the symptoms of defecatory obstruction
To carry out the research a questionnaire was used to collect epidemiological clinical and functional data from patients with grade II to IV mucohemorrhoidal disease who had surgical indication for PPH The Constipation Scores questionnaire Altomare and Agachan-Wexner was used to identify patients with symptoms of defecatory obstruction The sample was divided into two groups an experimental group which included patients with symptoms of defecatory obstruction and a control group made up of patients without such symptoms Functional studies were carried out such as colonic transit time and the balloon expulsion test Subsequently the PPH technique was performed and after one month postoperatively the Constipation Scores and functional studies were evaluated to determine if there was an improvement in the initial scores
The study was designed as a quasi-experimental study and was also supported by an analytical case-control study Its aim was to assess patients with grades II to IV mucohemorrhoidal disease who required PPH
The research focused on applying theoretical concepts related to defecatory obstruction secondary to mucohemorrhoidal prolapse which results in difficulties with an adequate defecatory act The main objective was to determine if surgery for hemorrhoidal prolapse and pexia could correct the symptoms of obstructed defecation as proposed by Longo The study established facilities to evaluate and provide pre- and postoperative follow-up to patients with symptoms of defecatory obstruction The research question posed was In patients with mucohemorrhoidal disease and symptoms of defecatory obstruction can the PPH technique improve the symptoms of defecatory obstruction
To carry out the research a questionnaire was used to collect epidemiological clinical and functional data from patients with grade II to IV mucohemorrhoidal disease who had surgical indication for PPH The Constipation Scores questionnaire Altomare and Agachan-Wexner was used to identify patients with symptoms of defecatory obstruction The sample was divided into two groups an experimental group which included patients with symptoms of defecatory obstruction and a control group made up of patients without such symptoms Functional studies were carried out such as colonic transit time and the balloon expulsion test Subsequently the PPH technique was performed and after one month postoperatively the Constipation Scores and functional studies were evaluated to determine if there was an improvement in the initial scores
The study was designed as a quasi-experimental study and was also supported by an analytical case-control study Its aim was to assess patients with grades II to IV mucohemorrhoidal disease who required PPH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None