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Completed

NCT Number: NCT06502184

Mental Health Outcome After Surgery for Obstructed Defecation Syndrome (ODS)

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.

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Key information

Conditions

Surgery Anxiety Disorders Behavior Behavioral Symptoms Depression Depression/Anxiety Mental Disorders Mental Health Issue Obstructive Defecation Syndrome Outcomes Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evanglisches Klinikum Koeln Weyertal

Cologne, 50931, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obstructed Defecation Syndrome (ODS) scheduled for Surgery
  • Conservative treatment failure
  • Laparoscopic access possible

Exclusion criteria

  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Mental Health Outcome - Depression

    Time frame: 6 months

    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).

  2. Mental Health Outcome - Anxiety

    Time frame: 6 months

    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).

Secondary outcomes

  1. Bowel Function - Altomare Score

    Time frame: 6 months

    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.

  2. Bowel Function - rectal toxicity score

    Time frame: 6 months

    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 .

  3. Bowel Function - Wexner incontinence score

    Time frame: 6 months

    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.

Other outcomes

  1. Surgical Outcome

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Evangelisches Klinikum Köln Weyertal gGmbH

Other

Collaborators

  • University Hospital of Cologne

Registry information

Official study title

Functional and Mental Outcomes After Interdisciplinary Surgery for Patients With Obstructive Defecation Syndrome (ODS)

Acronym: MentODSSurg

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 16, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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