An observational study in Surgery, Obstructive Defecation Syndrome and Mental Health Issue, sponsored by Evangelisches Klinikum Köln Weyertal gGmbH. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Evangelisches Klinikum Köln Weyertal gGmbH · Observational
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.
Aim, design, and setting of the study:
This study measures the mental burden of Obstructed Defecation Synsdrome (ODS) in patients scheduled for surgery for Obstructed Defecation Synsdrome (ODS) before and 6 months after surgery. The results are linked to how well the bowel works. All scores are checked before surgery and at 6 months after.
What do the investigators do to find this out ? The investigators look at patients' age, sex, body mass index (BMI), and other health problems. Defecation symptoms are measured using a validated questionnaire, the Altomare score, which has a maximum of 30 points. 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. The Wexner score is a 20-point questionnaire for fecal incontinence symptoms. Higher scores indicate greater severity of symptoms. Mental disorders are evaluated using the Personal Health Questionnaire 9 (PHQ-9) and General Anxiety Disorder 7 (GAD-7). Higher scores mean more severe symptoms.
Surgical procedure: For laparoscopic surgery under general anaesthesia, the patient is kept in a dorsal lithotomy position with their head down. The procedure opens the rectum, removes a part of the bowel and then rebuilds bowel continuity.
The investigators collect data on how long the operation took, how long the patient stays in hospital, and how many people have complications after the operation.
The scores will be reassessed at 6 months after surgery. For the clinical outcome, an improvement will be assumed at a reduction of 3 points and a strong improvement at a reduction of 6 points. Similarly, deterioration and major deterioration will be assumed at an increase of 3 points and 6 points. The results will be analyzed statistically.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 140 is below the median of 160 across 1,084 observational studies indexed under Depression.
Browse Depression studies →Evangelisches Klinikum Köln Weyertal gGmbH is the lead sponsor of 5 studies on the registry; none are open to participants now.
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The clinical and mental burdens of a consecutive group of patients, who is scheduled for surgery of Obstructed Defecation Syndrome (ODS) at the Evangelisches Klinikum Köln Weyertal, an academic teaching hospital associated with the university hospital cologne, which accommodates a tertiary pelvic organ and bowel dysfunction center as part of the surgical department, will be assessed before and 6 months after surgery.
The self-reported clinical (bowel function) and mental score data are prospectively acquired as part of the standard operating procedure for all patients with functional bowel motility disorders in the investigators' hospital. Informed consent for the planned procedure, data collection, and publication of the results was obtained from all patients before surgery.
Exclusion Criteria:
laparoscopic resection rectopexy is performed
Mental Health Outcome - Depression
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).
Time frame: 6 months
Mental Health Outcome - Anxiety
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).
Time frame: 6 months
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.
Time frame: 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 .
Time frame: 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.
Time frame: 6 months
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.
Time frame: 6 months
Plan to share: No — Patients are not willing to share the data
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Evangelisches Klinikum Köln Weyertal gGmbH