Rectal SurgeryPERIFUNCNCT05257746
Perioperative and Postoperative Evaluation of Rectal and Urogenital Function in Patients Undergoing Rectal Resection
An observational study of Rectal Surgery, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The aim of this study is the systematic analysis of the development of perioperative rectal and urogenital function in patients undergoing rectal resection with total mesorectal excision and the identification of risk factors for urogenital and sphincter function loss after this procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Surgery
- What is being tested?
- Rectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 3 Mar 2021to 30 Jun 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing rectal resection with total mesorectal excision
Who may be able to join
- Patients undergoing rectal resection with total mesorectal excision
Who cannot join
- primary or secondary removal of rectal sphincter apparatus
- patients with enterostomy persisting 12 months after initial rectal resection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
Dresden, Saxony, 01307
Johannes Fritzmann, Dr., +49 351 458 19477, johannes.fritzmann@ukdd.de
Fiona Kolbinger, Dr.
About this study
The aim of this study is the systematic analysis of the development of perioperative rectal and urogenital function in patients undergoing rectal resection with total mesorectal excision and the identification of risk factors for urogenital and sphincter function loss after this procedure. Knowledge of the corresponding risk factors could enable the identification of patient cohorts that could benefit from an intensified or altered postoperative treatment path. The results of this study could thus significantly influence the clinical management of patients with rectal cancer and improve the functional outcome in the long term.
- Conditions
- Rectal Surgery
- Being tested
- Rectal resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal resectionProcedure or surgery
Open or minimally invasive rectal resection with total mesorectal excision
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pelvic function before and after rectal resection
Rectal and urogenital function will be assessed preoperatively and 12-24 months and 5 years postoperatively using the PERIFUNC score questionnaire, resulting in a score between 0 and 120. Higher scores mean a worse outcome (worse pelvic function).
Measured: 5 years
Rectal sphincter function before and after rectal resection
Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively
Measured: 5 years
Assessment of stool continence before and after rectal resection
Stool continence will be assessed preoperatively and 12-24 months and 5 years postoperatively using the LARS score questionnaire, resulting in a score between 0 and 42. Higher scores mean a worse outcome (worse stool continence).
Measured: 5 years
Secondary outcomes (6)
Operating time [min]
Time from skin incision until placement of last skin staple/suture.
Measured: during surgery
Intraoperative blood loss [mL]
Intraoperative blood loss presents the amount of blood lost from skin incision until skin closure. Spilling water and ascites will be subtracted. Swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers
Measured: during surgery
Duration of postoperative hospital stay [days]
Postoperative day 1 until day of discharge
Measured: At day of discharge, assessed up to 90 days
Duration of postoperative intermediate/intensive care unit stay [days]
Postoperative day 1 until day of discharge
Measured: At day of discharge, assessed up to 90 days
Frequency of peri-operative morbidity after resection
Frequency of peri-operative complications after resection
Measured: 90 days after surgery
Kind of peri-operative morbidity after resection
Kind of peri-operative complications after resection
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start3 Mar 2021
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal SurgeryStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Fritzmann, Dr., Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257746
- Sponsor's protocol ID
- VTG-10
- Acronym
- PERIFUNC
- Status last verified
- Aug 2026
- First submitted
- 7 Feb 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Following publication of study results, de-identified patient data will be made available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative and Postoperative Evaluation of Rectal and Urogenital Function in Patients Undergoing Rectal Resection
- ClinicalTrials.gov ID
- NCT05257746
- Acronym / sponsor ID
- PERIFUNC / VTG-10
- Conditions
- Rectal Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 25 Feb 2022 (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.
The aim of this study is the systematic analysis of the development of perioperative rectal and urogenital function in patients undergoing rectal resection with total mesorectal excision and the identification of risk factors for urogenital and sphincter function loss after this procedure. Knowledge of the corresponding risk factors could enable the identification of patient cohorts that could benefit from an intensified or altered postoperative treatment path. The results of this study could thus significantly influence the clinical management of patients with rectal cancer and improve the functional outcome in the long term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing rectal resection with total mesorectal excision
Key inclusion criteria (1 listed)
- Patients undergoing rectal resection with total mesorectal excision
Key exclusion criteria (2 listed)
- primary or secondary removal of rectal sphincter apparatus
- patients with enterostomy persisting 12 months after initial rectal resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal resectionOpen or minimally invasive rectal resection with total mesorectal excision | Procedure or surgery | – |
Primary outcome
Assessment of pelvic function before and after rectal resection
Time frame: 5 years
Rectal and urogenital function will be assessed preoperatively and 12-24 months and 5 years postoperatively using the PERIFUNC score questionnaire, resulting in a score between 0 and 120. Higher scores mean a worse outcome (worse pelvic function).
Rectal sphincter function before and after rectal resection
Time frame: 5 years
Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively
Assessment of stool continence before and after rectal resection
Time frame: 5 years
Stool continence will be assessed preoperatively and 12-24 months and 5 years postoperatively using the LARS score questionnaire, resulting in a score between 0 and 42. Higher scores mean a worse outcome (worse stool continence).
6 secondary outcomes
Operating time [min]
Time frame: during surgery
Intraoperative blood loss [mL]
Time frame: during surgery
Duration of postoperative hospital stay [days]
Time frame: At day of discharge, assessed up to 90 days
Duration of postoperative intermediate/intensive care unit stay [days]
Time frame: At day of discharge, assessed up to 90 days
Frequency of peri-operative morbidity after resection
Time frame: 90 days after surgery
Kind of peri-operative morbidity after resection
Time frame: 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. Following publication of study results, de-identified patient data will be made available upon reasonable request
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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.
Johannes Fritzmann, Dr. principal investigator
Technische Universität Dresden
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 Rectal Surgery, run by Technische Universität Dresden 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Fritzmann, Dr. (+49 351 458 19477, johannes.fritzmann@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pelvic function before and after rectal resection (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026.