Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair

Defecation Function Clinical Trial

Official title:

Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253689
• Other study ID #: 23-087
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: TriHealth Inc.
• Contact: Meredith Carrel-Lammert
• Phone: 513-463-4300
• Email: meredith_carrel-lammert[@]trihealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will determine if defecation posture, when using a defecation posture modification device (DPMD), improves ease with first bowel movement following pelvic reconstructive surgery, specifically posterior repair.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: April 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing surgery by one of the sub investigators including a posterior compartment repair

Exclusion Criteria:

• Anyone currently using a defecation posture modification device

• Unwillingness or unable to participate in the study

• Presence of ileostomy/colostomy

• Wheelchair bound

• Device may pose fall or safety hazard risk to patient

• Patients weighing over 250 lbs, as per device manufacturer guidelines

• Inability to understand English

• Pregnant women

Related Conditions & MeSH terms

• Constipation
• Defecation Function
• Pelvic Organ Prolapse
• Pelvic Organ Prolapse Vaginal Surgery
• Postoperative Constipation
• Prolapse

Intervention

Device:
• Defecation Posture Modification Device
Patients assigned to the experimental arm will be asked to use the defecation posture modification device to aid with bowel movements during the postoperative period.

Locations

Country	Name	City	State
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Cincinnati Urogynecology Associates	Cincinnati	Ohio
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Straining with first postoperative bowel movement	patients will keep 7 day log of each postoperative bowel movement within the first week of surgery, they will assess with an 11 point numeric rating scale their level of strain with bowel movement, the scale starts at 0 indicating no straining and 10 indicating maximal straining/effort. I high score of 10 means a worse outcome. The scale title is "straining with bowel movement".	1 week
Secondary	postoperative stool consistency	7 day bowel movement diary using bristol stool scale to describe stool consistency. The Bristol Stool scale is a validated scale to describe each type stool consistency. The scale is from Type 1 - Type 7. Type 1 is separate hard lumps of stool and ranges up to Type 7 which is watery and entirely liquid stool. In this scale the two ends (high and low) are concerned worse outcomes, the middle of the scale - Type 4 is the ideal outcome.	1 week
Secondary	Time to first bowel movement	7 day log for patients to track bowel movements within 1st week of surgery	1 week
Secondary	pain with postoperative bowel movements	7 day log where patients input each bowel movement for the first week postoperative, 11 point numeric scale for tracking pain. The scale is a pain rating scale with 0 indicating no pain with bowel movements and 10 indicating worst possible pain with bowel movements. The title of the scale is "Pain with bowel movements". The worse outcome is a 10 and the best outcome is a zero.	1 week
Secondary	Postoperative use of laxatives and pain medication	patients will keep 7 day log of daily usage of standard postoperative pain medication and laxative use	1 week
Secondary	Satisfaction with device and ease of use	patients will receive a questionnaire with questions regarding their satisfaction with the device and ease of use. When asked about satisfaction of the device, patients will be given an 11 point numeric scale assessing satisfaction. The number 0 will indicate not satisfied and 10 will indicate very satisfied with use of the device. The title of the scale is "satisfaction with device". The Best outcome is a 10 and the worst outcome is a 0.	1 month