Ignite Creation Date:
2024-10-26 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502184
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Mental Health Outcome After Surgery for Obstructed Defecation Syndrome ODS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Functional and Mental Outcomes After Interdisciplinary Surgery for Patients with Obstructive Defecation Syndrome ODS
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MentODSSurg
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None