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临床试验/NCT06294470
NCT06294470已完成不适用

Efficacy of the Hemorrhoidal Prolapse and Pexia Procedure for the Treatment of Defecatory Obstruction Syndrome.

Universidad Central de Venezuela2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Postoperative improvement of symptoms of defecatory obstruction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Experimental

Experimental

Altomare Score score ≥3pts and Agachan Wexner Score ≥12pts

干预措施: Stapled hemorrhodopexy (Procedure)

Control

Active Comparator

Altomare Score score <3pts and Agachan Wexner Score <12pts

干预措施: Ballon expulsion test (Diagnostic Test)

Control

Active Comparator

Altomare Score score <3pts and Agachan Wexner Score <12pts

干预措施: Colonic transit time (Diagnostic Test)

Control

Active Comparator

Altomare Score score <3pts and Agachan Wexner Score <12pts

干预措施: Stapled hemorrhodopexy (Procedure)

Experimental

Experimental

Altomare Score score ≥3pts and Agachan Wexner Score ≥12pts

干预措施: Ballon expulsion test (Diagnostic Test)

Experimental

Experimental

Altomare Score score ≥3pts and Agachan Wexner Score ≥12pts

干预措施: Colonic transit time (Diagnostic Test)

结局指标

主要结局

Postoperative improvement of symptoms of defecatory obstruction

时间窗: 1 month

Change From Baseline in Altomare Score and Agachan Wexner Score \[Time Frame: 1 month\]. Altomare Score: Assessed using an interviewer-led questionnaire with eight items (time spent at toilet, attempts to defecate each day, digitation, laxatives, enemas, straining, consistency, completeness), each rated on a 3- or 4-point Likert scale. Scores range from 0 (no symptoms) to 3 or 4 (severe symptoms), with a max score of 31 indicating obstructive defecatory syndrome (\>3). Higher scores denote worse symptoms. Agachan Wexner Score: Derived from eight variables (Frequency of bowel movements, effort, Completeness, pain, time, assistance, failure, history), scored from 0 to 4 (except "assistance for defecation," 0-2). Global score is the sum, with \>12 indicating constipation symptoms. Higher scores indicate worse defecatory obstruction symptoms.

次要结局

  • Postoperative change of the balloon expulsion test(1 month)
  • Postoperative change of the colonic transit time(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristopher Varela

M.D.

Universidad Central de Venezuela

研究点 (2)

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