study to assess the degree of comfort with simple Emuliquen® in patients undergoing proctological surgery

Unilateral, open and randomized phase IV study of 2 groups to assess the degree of comfort with simple Emuliquen® in patients undergoing proctological surgery - LAINCO1107

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002811-33-ES

Enrollment

120

Registered

2017-10-10

Start date

2017-12-11

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery proctological MedDRA version: 20.0 Level: LLT Classification code 10042759 Term: Symptoms involving digestive system System Organ Class: 100000016398

Interventions

Trade Name: Emuliquen Product Name: EMULIQUEN Product Code: 16678 Pharmaceutical Form: Oral emulsion INN or Proposed INN: SODIUM PICOSULFATE CAS Number: 10040-45-6 Current Sponsor code: 16678 Other de

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 to evaluate the pain reliever in the act of defecation to determine diarrhea processes evaluate fecal impaction. determine if there has been infection of the surgical wound	—

Measure

Time frame

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 to evaluate the pain reliever in the act of defecation to determine diarrhea processes evaluate fecal impaction. determine if there has been infection of the surgical wound

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Secondary

Measure	Time frame
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. 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. Processes of diarrhea (according to the Bristol Stool Scale) during the treatment period. Fecal impaction during the treatment period. Infection of the wound during the treatment period.;Timepoint(s) of evaluation of this end point: during 4-5 weeks	—

Measure

Time frame

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. 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. Processes of diarrhea (according to the Bristol Stool Scale) during the treatment period. Fecal impaction during the treatment period. Infection of the wound during the treatment period.;Timepoint(s) of evaluation of this end point: during 4-5 weeks

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Countries

Spain

Contacts

Public ContactTeresa Pascual

Dynamic

t.pascual@dynasolutions.com0000+ 34 91 456 11 0500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026