One surgery, two problems? a new approach to pelvic floor repair
NCT ID NCT05910021
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This trial investigates whether combining two laparoscopic procedures—resection rectopexy and sacrocolpopexy—can safely and effectively treat women who have both pelvic organ prolapse and obstructive defecation syndrome (a type of chronic constipation). The study will enroll 35 women who are eligible for laparoscopic surgery and can undergo general anesthesia. Researchers will measure safety by tracking post-surgical complications and evaluate effectiveness by assessing prolapse severity and bowel function after the procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Combined laparoscopic resection rectopexy and sacrocolpopexy surgery
- What this could lead to
- If successful, this combined surgical approach could offer a more effective, one-time treatment for women suffering from both pelvic organ prolapse and severe constipation, improving quality of life.
- What could go wrong
- This is an early, small study (35 participants) focused on safety and short-term outcomes. Surgery carries risks like complications from anesthesia, bleeding, infection, or injury to nearby organs, and long-term effectiveness is not yet established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
35 people
The number who actually took part.
- Started
-
Feb 2020
- Finished
-
Jul 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Women over 18 years of age, not pregnant and suffering from the obstructed defecation disorder and a pelvic organ prolapse. Medical treatment was performed without success and surgery is needed.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * suffering from obstructed defecation and pelvic organ prolapse * can undergo general anesthesia * is eligible for laparoscopic surgery Exclusion Criteria: * pregnancy
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Constipation by outlet obstruction are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
EVK Koeln Weyertal
Cologne, North Rhine-Westphalia, 50931, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can strength training steady the walk and strengthen the pelvic floor after menopause?
- Can a biological mesh improve pelvic floor surgery?
- Estrogen drop may hold clue to bladder leaks in women with spinal cord injury
- Bladder leaks may signal frailty in older adults
- Can targeted exercises ease mild pelvic organ prolapse without surgery?
- A gentler catheter may cut infection risk for women in hospitals