Clinical trial NCT06502184: Mental Health Outcome After Surgery for Obstructed Defecation Syndrome (ODS)
Official title: Functional and Mental Outcomes After Interdisciplinary Surgery for Patients With Obstructive Defecation Syndrome (ODS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Evangelisches Klinikum Köln Weyertal gGmbH
Sponsor class: OTHER
Collaborators: name: University Hospital of Cologne
First posted: 2024-07-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Primary outcomes:
measure: Mental Health Outcome - Depression
timeFrame: 6 months
measure: Mental Health Outcome - Anxiety
timeFrame: 6 months
Secondary outcomes:
measure: Bowel Function - Altomare Score
timeFrame: 6 months
measure: Bowel Function - rectal toxicity score
timeFrame: 6 months
measure: Bowel Function - Wexner incontinence score
timeFrame: 6 months
Other outcomes:
measure: Surgical Outcome
timeFrame: 6 months
Locations:
city: Cologne
country: Germany
facility: Evanglisches Klinikum Koeln Weyertal
Study officials:
affiliation: Evangelisches Klinikum Köln Weyertal
name: Claudia L Rudroff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.