study to assess the degree of comfort with simple Emuliquen® in patients undergoing proctological surgery
- Conditions
- Surgery proctologicalMedDRA version: 20.0Level: LLTClassification code 10042759Term: Symptoms involving digestive systemSystem Organ Class: 100000016398Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-002811-33-ES
- Lead Sponsor
- AINCO S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Patients of both sex, between 18 and 75 years.
Patients who will be operated on for anorectal surgery, including hemorrhoids, fissure, anal fistula or benign anal canal polyps, regardless of the surgical technique to be used.
Patients who have given informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Cancer patient.
Patient with chronic functional constipation, according to Rome III criteria.
Patient with irritable bowel syndrome, according to Rome III criteria.
Woman of childbearing age with positive urine pregnancy test.
Patients who are participating in another clinical trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Percentage of patients who present intestinal colic and flatulence during treatment administration;Timepoint(s) of evaluation of this end point: During 4-5 weeks;Main Objective: To evaluate the degree of comfort that patients experience after undergoing proctological surgery;Secondary Objective: determine the degree of effort defecation<br>to evaluate the pain reliever in the act of defecation<br>to determine diarrhea processes<br>evaluate fecal impaction.<br>determine if there has been infection of the surgical wound
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Degree of effort in defecation (using a scale of 0 = incontinence, 1 = slides, no effort, 2 = normal, 3 = a lot of pain) during treatment administration.<br>Degree of pain in defecation (using a visual analogue scale (EVA) of 0-10 cm, where 0 = no pain and 10 = maximum possible pain) during treatment administration.<br>Processes of diarrhea (according to the Bristol Stool Scale) during the treatment period.<br>Fecal impaction during the treatment period.<br>Infection of the wound during the treatment period.;Timepoint(s) of evaluation of this end point: during 4-5 weeks