Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06294470 |
Other study ID # |
01-2023 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2023 |
Est. completion date |
December 15, 2023 |
Study information
Verified date |
March 2024 |
Source |
Universidad Central de Venezuela |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.