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

NCT06502184 | Completed

• 1 other identifier: Mental health in ODS Surgery
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  6 months

Secondary Outcomes (3)

• Bowel Function - Altomare Score

  6 months

• Bowel Function - rectal toxicity score

  6 months

• Bowel Function - Wexner incontinence score

  6 months

Other Outcomes (1)

• Surgical Outcome

  6 months

Study Arms (1)

cohort of all patients who receive ODS surgery

laparoscopic resection rectopexy is performed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Evangelisches Klinikum Köln Weyertal gGmbH: lead
• University Hospital of Cologne: collaborator

Study Sites (1)

Evanglisches Klinikum Koeln Weyertal

Cologne, 50931, Germany

Location

Related Publications (1)

• 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.

  PMID: 38877450 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Claudia L Rudroff, MD

  Evangelisches Klinikum Köln Weyertal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department of visceral surgery and functional surgery of the lower gastrointestinal tract

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: February 1, 2020
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)