SurgeryMentODSSurgNCT06502184
Mental Health Outcome After Surgery for Obstructed Defecation Syndrome (ODS)
An observational study of Surgery and Obstructive Defecation Syndrome, run by Evangelisches Klinikum Köln Weyertal gGmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Obstructive Defecation Syndrome, Mental Health Issue
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2020to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Obstructed Defecation Syndrome (ODS) scheduled for Surgery
- Conservative treatment failure
- Laparoscopic access possible
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional and Mental Outcomes After Interdisciplinary Surgery for Patients With Obstructive 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.
Read the detailed description
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.
- Conditions
- Surgery, Obstructive Defecation Syndrome, Mental Health Issue, Depression/Anxiety, Outcomes
- Keywords
- mental health, depression, anxiety, obstructed defecation syndrome, surgery, bowel resection, rectopexy, outcome, follow up
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cohort of all patients who receive ODS surgery | laparoscopic resection rectopexy is performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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 .
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Feb 2020
- Primary completion31 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelisches Klinikum Köln Weyertal gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Cologne
- Responsible party
- Principal investigator, Claudia Rudroff, Evangelisches Klinikum Köln Weyertal gGmbH
- Investigators
- Claudia L Rudroff, MD, Principal investigator, Evangelisches Klinikum Köln Weyertal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502184
- Sponsor's protocol ID
- Mental health in ODS Surgery
- Acronym
- MentODSSurg
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients are not willing to share the data
Publications
Rudroff C, Madukkakuzhy J, Hernandez AV, Otten J, Ulrici C, Karapanos L, Ludwig S. Early safety and efficiency outcomes of a novel interdisciplinary laparoscopic resection rectopexy combined with sacrocolpopexy for women with obstructive defecation syndrome and pelvic organ prolapse: a single center study. BMC Surg. 2024 Jun 14;24(1):185. doi: 10.1186/s12893-024-02474-4.
PubMed 38877450Rudroff C, Madukkakuzhy J, Otten J, Schroer J, Richards D, Ludwig S, Henning M. Improvement in functional and mental outcomes after resection rectopexy for obstructive defecation syndrome ODS. Sci Rep. 2025 Aug 18;15(1):30184. doi: 10.1038/s41598-025-15037-1.
PubMed 40825813
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Mental Outcomes After Interdisciplinary Surgery for Patients With Obstructive Defecation Syndrome (ODS)
- ClinicalTrials.gov ID
- NCT06502184
- Acronym / sponsor ID
- MentODSSurg / Mental health in ODS Surgery
- Conditions
- Surgery, Obstructive Defecation Syndrome, Mental Health Issue, Depression/Anxiety, Outcomes
- Keywords
- mental health, depression, anxiety, obstructed defecation syndrome, surgery, bowel resection, rectopexy, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Evangelisches Klinikum Köln Weyertal gGmbHUniversity, hospital or other
- Collaborators
- University Hospital of Cologne
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort of all patients who receive ODS surgery | – | –laparoscopic resection rectopexy is performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Obstructed Defecation Syndrome (ODS) scheduled for Surgery
- Conservative treatment failure
- Laparoscopic access possible
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
3 secondary outcomes
Bowel Function - Altomare Score
Time frame: 6 months
Bowel Function - rectal toxicity score
Time frame: 6 months
Bowel Function - Wexner incontinence score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 38877450Rudroff C, Madukkakuzhy J, Hernandez AV, Otten J, Ulrici C, Karapanos L, Ludwig S. Early safety and efficiency outcomes of a novel interdisciplinary laparoscopic resection rectopexy combined with sacrocolpopexy for women with obstructive defecation syndrome and pelvic organ prolapse: a single center study. BMC Surg. 2024 Jun 14;24(1):185. doi: 10.1186/s12893-024-02474-4.
- Results publication: PubMed 40825813Rudroff C, Madukkakuzhy J, Otten J, Schroer J, Richards D, Ludwig S, Henning M. Improvement in functional and mental outcomes after resection rectopexy for obstructive defecation syndrome ODS. Sci Rep. 2025 Aug 18;15(1):30184. doi: 10.1038/s41598-025-15037-1.
- Individual participant dataSharing planned: No. Patients are not willing to share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia L Rudroff, MD principal investigator
Evangelisches Klinikum Köln Weyertal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Obstructive Defecation Syndrome, run by Evangelisches Klinikum Köln Weyertal gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Outcome - Depression (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06502184, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.