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The Effect of Melatonin in Patients With Low Anterior Resection Syndrome

NCT05042700 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-04-25

No results posted yet for this study

Summary

The primary objective of the study is to investigate whether treatment with melatonin has an alleviating effect on Low Anterior Resection Syndrome (LARS) symptoms. Secondarily, the effect of the treatment on bowel movements, other patient reported symptoms, quality of life, depression, anxiety, sleep disturbances, motilin levels, and microscopic changes in rectal mucosa will be investigated.

Conditions

  • Low Anterior Resection Syndrome

Interventions

DRUG

Melatonin

Enema with 25 mg melatonin

DRUG

Placebo

Enema without melatonin

Sponsors & Collaborators

  • Hvidovre University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Ismail Gögenur

    lead OTHER

Principal Investigators

  • Ismail Gögenur, DMSc · Zealand University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05042700 on ClinicalTrials.gov