Clinical trial NCT06294470: Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome
Official title: Efficacy of the Hemorrhoidal Prolapse and Pexia Procedure for the Treatment of Defecatory Obstruction Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Defecation Disorder
Keywords: Hemorrohoids
Obstructive Defecation Syndrome
Stapled hemorrhoidopexy
Lead sponsor: Universidad Central de Venezuela
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 70 years old.
* Patients diagnosed with grade II to IV mucohemorrhoidal disease and suffering from symptoms of obstructed defecation, which require a procedure for prolapse and hemorrhoidal pexia.
* Patients with a minimum Altomare Score of 3pts and Agachan Score Wexner of at least 12pts.

Exclusion Criteria:

* Patients who, after undergoing a colonic transit time study, are found to have a different type of constipation (such as slow transit or colonic inertia).
* Patients who undergo PPH technique along with another anorectal procedure.
* Patients with any other anorectal conditions, including fistula, anal fissure, inflammatory bowel disease, chronic diarrhea, or malignant lesions.
* Patients diagnosed with mucohemorrhoidal disease and experiencing acute complications.

Primary outcomes:
measure: Postoperative improvement of symptoms of defecatory obstruction
timeFrame: 1 month
Secondary outcomes:
measure: Postoperative change of the balloon expulsion test
timeFrame: 1 month
measure: Postoperative change of the colonic transit time
timeFrame: 1 month
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Hospital Domingo Luciani
state: Miranda
Study officials:
affiliation: Instituto Venezolano de los Seguros Sociales
name: Cristopher Varela, MD
role: PRINCIPAL_INVESTIGATOR
References: