FOAM: Functional Outcome After Ventral Mesh Rectopexy

Launched by UPPSALA UNIVERSITY · Jun 11, 2024

Keywords

ClinConnect Summary

The FOAM trial is studying a surgical procedure called Ventral mesh rectopexy, which is used to treat a condition known as rectal prolapse. This condition occurs when the rectal wall pushes out through the anus, causing discomfort and other issues. The goal of the trial is to find out if this surgery improves bowel function, quality of life, and sexual function for patients. Researchers will collect information from participants through questionnaires before the surgery and again at 3-6 months and 12 months after the surgery. They will also have follow-up examinations by a surgeon at these same time points and again at three years after the procedure.

To be eligible for this trial, participants must be adults aged 18 and older with a full-thickness rectal prolapse who need the surgery as determined by their surgeon. Participants must also be able to understand and answer questions, provide informed consent, and attend follow-up appointments. However, those who are pregnant, have dementia or other cognitive disorders, or cannot understand Swedish will not be included in the study. This trial is not yet recruiting participants, but it aims to provide valuable information about the results of this surgical treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • full-thickness rectal prolapse
• • the surgeon agrees that ventral mesh rectopexy is needed for the condition
• • capable of participating in follow-up visits and answering questionnaires
• • informed consent
• Exclusion Criteria:
• • patient below 18 years of age
• • ongoing pregnancy
• • inability to understand the Swedish language
• • dementia or other cognitive disorder that unables informed consent