Constipation by Outlet ObstructionRRPSCPcombNCT05910021
Early Safety of Resection Rectopexy and Sacrocolpopexy
An observational study of Constipation by Outlet Obstruction and Pelvic Organ Prolapse, run by Evangelisches Klinikum Köln Weyertal gGmbH at 1 site in Germany.
Trial summary
Obstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women. It substantially compromises quality of life and conservative treatment options are limited. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Constipation by Outlet Obstruction, Pelvic Organ Prolapse, Urinary Incontinence
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2020to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- suffering from obstructed defecation and pelvic organ prolapse
- can undergo general anesthesia
- is eligible for laparoscopic surgery
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Safety and Efficiency of Interdisciplinary Laparoscopic Resection Rectopexy Combined With Sacrocolpopexy for Women With Obstructive Defecation Syndrome and Pelvic Organ Prolapse
Obstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women. It substantially compromises quality of life and conservative treatment options are limited. In cases surgery is required the interventions are characterized by individual approaches. Laparoscopic resection rectopexy (L-RRP) combined with laparoscopic sacrocolpopexy (L-SCP) was established in an interdisciplinary setting.
Read the detailed description
Obstructive defecation syndrome (ODS) defines a disturbed defecation process caused by the protrusion of the lower rectum (rectocele) or the telescoping within the rectum (intussusception). The patients must exert pressure to evacuate the rectum and manual manipulation may be required. The unsuccessful attempts to defecate are associated with a feeling of incomplete rectal voiding. ODS affects approximately 10%-25% of the population and is mainly related to female sex. The condition is frequently associated with POP. On the other hand almost 60% of the female population develop POP during their lifetime and 1/3 of them suffer bowel dysfunction. Individual aspects, such as pregnancy, childbirth, connective tissue disorders, and surgical interventions further contribute to the condition. The women experience frustration due to their disturbed defecation, compromising their quality of life substantially. Conservative treatment options are limited and do not achieve the desired long-term effect.
The surgical treatment aims at the anatomic reconstruction of the bowel and pelvic floor and has been characterized by individual approaches.
This pilot study established and standardized an interdisciplinary surgical approach of laparoscopic resection rectopexy (L-RRP) combined with a laparoscopic mesh sacrocolpopexy (L-SCP) used synonymously for all surgical reconstructions. Additionally, an absorbable biological mesh (BM) for L-SCP was offered for women who wished to preserve the uterus in cases of a planned pregnancy and those, who asked for an alternative to the synthetic mesh (SM).
- Endpoints of the study The primary study outcome parameters were the safety and efficacy of the combined laparoscopic procedure.as measured by postoperative morbidity and mortality and measured. The secondary outcome parameters were clinical and anatomical outcomes as measured by scores.
- Data management and statistical analysis The necessary clinical data were collected preoperatively, during the hospital stay, and during the follow-up examinations. All scores were documented on paper and transferred to a data bank. Data were analyzed. Quantitative variables are described as means (± standard deviation) and were compared using the Kruskal-Wallis H test and Mann-Whitney U test. Qualitative variables are summarized using count, percentage, median, and interquartile range and were compared using the Fisher's exact test. A two-sided p value of <0.05 was considered statistically significant. Because no adjustments for multiple testing were performed, the analysis were exploratory.
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with ODS and POP | This pilot study established and standardized an interdisciplinary surgical approach of laparoscopic resection rectopexy (L-RRP) combined with a laparoscopic mesh sacrocolpopexy (L-SCP) used synonymously for sacrohysteropey and sacrocervicopexy, as well. Additionally, an absorbable biological mesh ( |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the procedure
Complication after Surgery by Clavien Dingo Score (minimum 0=no complication, 1= complication with no intervention, 2= complication with need for medication, 3a= complication with need for intervention, 3b = need for intervention under general anesthesia, 4a = septic complication, 4b= Multiorgan failure, and maximum 5= death
Measured: 12 months
Secondary outcomes (2)
pelvic organ prolapse (POP)
POP measured by POP-Q (Score ranges from 0= no POP, 1= POP until 2 cm before the hymnal line, 2= POP reached the hymnal line, 3= POP exceeds the hymnal line, 4= full extravgtnal prolapse)
Measured: 12 months
Defecation function
Altomare score (6 items, minimum=0, maximum = 32 points; the more points, the worse the defecation function)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Feb 2020
- Primary completion31 Mar 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Constipation by Outlet ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelisches Klinikum Köln Weyertal gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Rudroff, Evangelisches Klinikum Köln Weyertal gGmbH
- Investigators
- Claudia Rudroff, Principal investigator, EVK Köln Weyertal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910021
- Sponsor's protocol ID
- EVK KOELN
- Other IDs
- RRP_SCP_interdisciplinary
- Acronym
- RRPSCPcomb
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available upon request to the study coordinator.
Publications
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.
PubMed 38877450
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Safety and Efficiency of Interdisciplinary Laparoscopic Resection Rectopexy Combined With Sacrocolpopexy for Women With Obstructive Defecation Syndrome and Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT05910021
- Acronym / sponsor ID
- RRPSCPcomb / EVK KOELN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Evangelisches Klinikum Köln Weyertal gGmbHUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women. It substantially compromises quality of life and conservative treatment options are limited. In cases surgery is required the interventions are characterized by individual approaches. Laparoscopic resection rectopexy (L-RRP) combined with laparoscopic sacrocolpopexy (L-SCP) was established in an interdisciplinary setting.
Detailed description
Obstructive defecation syndrome (ODS) defines a disturbed defecation process caused by the protrusion of the lower rectum (rectocele) or the telescoping within the rectum (intussusception). The patients must exert pressure to evacuate the rectum and manual manipulation may be required. The unsuccessful attempts to defecate are associated with a feeling of incomplete rectal voiding. ODS affects approximately 10%-25% of the population and is mainly related to female sex. The condition is frequently associated with POP. On the other hand almost 60% of the female population develop POP during their lifetime and 1/3 of them suffer bowel dysfunction. Individual aspects, such as pregnancy, childbirth, connective tissue disorders, and surgical interventions further contribute to the condition. The women experience frustration due to their disturbed defecation, compromising their quality of life substantially. Conservative treatment options are limited and do not achieve the desired long-term effect.
The surgical treatment aims at the anatomic reconstruction of the bowel and pelvic floor and has been characterized by individual approaches.
This pilot study established and standardized an interdisciplinary surgical approach of laparoscopic resection rectopexy (L-RRP) combined with a laparoscopic mesh sacrocolpopexy (L-SCP) used synonymously for all surgical reconstructions. Additionally, an absorbable biological mesh (BM) for L-SCP was offered for women who wished to preserve the uterus in cases of a planned pregnancy and those, who asked for an alternative to the synthetic mesh (SM).
- Endpoints of the study The primary study outcome parameters were the safety and efficacy of the combined laparoscopic procedure.as measured by postoperative morbidity and mortality and measured. The secondary outcome parameters were clinical and anatomical outcomes as measured by scores.
- Data management and statistical analysis The necessary clinical data were collected preoperatively, during the hospital stay, and during the follow-up examinations. All scores were documented on paper and transferred to a data bank. Data were analyzed. Quantitative variables are described as means (± standard deviation) and were compared using the Kruskal-Wallis H test and Mann-Whitney U test. Qualitative variables are summarized using count, percentage, median, and interquartile range and were compared using the Fisher's exact test. A two-sided p value of <0.05 was considered statistically significant. Because no adjustments for multiple testing were performed, the analysis were exploratory.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with ODS and POP | – | –This pilot study established and standardized an interdisciplinary surgical approach of laparoscopic resection rectopexy (L-RRP) combined with a laparoscopic mesh sacrocolpopexy (L-SCP) used synonymously for sacrohysteropey and sacrocervicopexy, as well. Additionally, an absorbable biological mesh ( |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- suffering from obstructed defecation and pelvic organ prolapse
- can undergo general anesthesia
- is eligible for laparoscopic surgery
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of the procedure
Time frame: 12 months
Complication after Surgery by Clavien Dingo Score (minimum 0=no complication, 1= complication with no intervention, 2= complication with need for medication, 3a= complication with need for intervention, 3b = need for intervention under general anesthesia, 4a = septic complication, 4b= Multiorgan failure, and maximum 5= death
2 secondary outcomes
pelvic organ prolapse (POP)
Time frame: 12 months
Defecation function
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Results publication: PubMed 38877450Rudroff 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.
- Individual participant dataSharing planned: Yes. Data available upon request to the study coordinator.
Related trials for Constipation by Outlet Obstruction
Recruiting
Defecation Patterns in Constipated Patients
Constipation by Outlet Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Rudroff principal investigator
EVK Köln Weyertal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation by Outlet Obstruction and Pelvic Organ Prolapse, run by Evangelisches Klinikum Köln Weyertal gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the procedure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.