Mental Health Outcome After Surgery for Obstructed Defecation Syndrome (ODS)
NCT Number: NCT06502184
Acronym: MentODSSurg
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Surgery|Obstructive Defecation Syndrome|Mental Health Issue|Depression/Anxiety|Outcomes
Sponsor: Evangelisches Klinikum Köln Weyertal gGmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-02-01
Completion Date: 2023-04-30

Summary:
Background: Obstructed Defecation Synsdrome (ODS) causes people to strain and sometimes need help to go to the toilet. They think about going to the toilet a lot, which makes their lives worse. People with Obstructed Defecation Synsdrome (ODS) are more likely to be anxious and depressed than people with other illnesses.

Aim of the study: This study looked at how mental health affects Obstructed Defecation Synsdrome (ODS) patients before and after surgery.

Primary Outcome Measures: Mental Health Outcome, Depression in patients with Obstructed Defecation Syndrome (ODS) is measured with a questionnaire (score) before and after Surgery.

The Personal Health Questionnaire 9 (PHQ-9) as an established score for depressive symptoms is used. It has a maximum of 27 points and higher scores mean a worse outcome. The score is divided into five subgroups of depression severity, namely, nonminimal (0-4 points), mild (5-9 points), moderate (10-14 points), moderately severe (15-19 points), and severe (20-27 points)., 6 months|Mental Health Outcome, Anxiety in patients with Obstructed Defecation Syndrome (ODS) is measured with a questionnaire (score) before and after Surgery, as well, since this is another important outcome measure for mental health.

Anxiety symptoms are measured by the General Anxiety Disorder 7 questionnaire (GAD-7), which has a maximum of 21 Points. Higher scores represent a higher burden and a worse outcome. GAD-7 is devided into four subgroups that differentiate the severity of anxiety into minimal (0-4 points), mild (5-9 points), moderate (10-14 points), and severe levels (15-21 points)., 6 months
Secondary Outcome Measures: Bowel Function - Altomare Score, Bowel function scores after Surgery for Obstructed Defecation Syndrome (ODS) before an after 6 months from surgery.

Defecation symptoms were measured using the Altomare score, a validated ODS questionnaire with a maximum of 30 points. In the questionnaire higher scores indicate greater severity of symptoms. However, no validated cutoff levels exist for scoring., 6 months|Bowel Function - rectal toxicity score, Bowel function scores after Surgery for Obstructed Defecation Syndrome (ODS) before an after 6 months from surgery. The rectal toxicity score reflects abdominal and bowel discomfort, which is determined by questions related to bowel dysfunction symptoms, such as diarrhea, meteorism, bleeding, and abdominal pain during bowel movement and defecation, and has a maximum of 32 points. As for the Altomare score, for the rectal toxicity higher score values indicate greater severity of symptoms. However, no validated cutoff levels exist ., 6 months|Bowel Function - Wexner incontinence score, The Wexner incontinence score is an established questionnaire for fecal incontinence symptoms, with a maximum of 20 points. It is measured before surgery and after 6 months follow up, as well. As for the other questionnaires, higher scores indicate greater severity of symptoms. However, no validated cutoff levels exist., 6 months
Other Outcome Measures: Surgical Outcome, Morbiditiy and Mortality as measured by the Clavien Dindo Classification (CDC). The CDC distinguishes postoperative morbidity and mortality based on severity, which ranges from mild complications (CDC 1) and complications requiring medication (CDC 2) to complications requiring intervention in local anesthesia (CDC 3a) or narcosis (3b), septic complications (CDC 4a) combined with multiorgan failure (4b), and death (CDC 5). CDCs 1-3a are classified as minor complications, and CDCs 3b-4b are classified as major complications., 6 months