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RecruitingNCT05257746PERIFUNCUpdated Aug 27, 2026

Perioperative and Postoperative Evaluation of Rectal and Urogenital Function in Patients Undergoing Rectal Resection

An observational study in Rectal Surgery, sponsored by Technische Universität Dresden. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Technische Universität Dresden · Observational

From the registry’s dates

  • Started Mar 2021; still recruiting 5 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Rectal Surgery
03

In context

Lead sponsor

Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients undergoing rectal resection with total mesorectal excision

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing rectal resection with total mesorectal excision

Exclusion criteria

Exclusion Criteria:

  • primary or secondary removal of rectal sphincter apparatus
  • patients with enterostomy persisting 12 months after initial rectal resection
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • ProcedureRectal resection

    Open or minimally invasive rectal resection with total mesorectal excision

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 5 years

  2. Rectal sphincter function before and after rectal resection

    Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively

    Time frame: 5 years

  3. 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).

    Time frame: 5 years

Secondary outcomes

  1. Operating time [min]

    Time from skin incision until placement of last skin staple/suture.

    Time frame: during surgery

  2. 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

    Time frame: during surgery

  3. Duration of postoperative hospital stay [days]

    Postoperative day 1 until day of discharge

    Time frame: At day of discharge, assessed up to 90 days

  4. Duration of postoperative intermediate/intensive care unit stay [days]

    Postoperative day 1 until day of discharge

    Time frame: At day of discharge, assessed up to 90 days

  5. Frequency of peri-operative morbidity after resection

    Frequency of peri-operative complications after resection

    Time frame: 90 days after surgery

  6. Kind of peri-operative morbidity after resection

    Kind of peri-operative complications after resection

    Time frame: 90 days after surgery

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Study locations

1 of 1 sites recruiting
  • Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
    Dresden, Saxony 01307, Germany
    Recruiting
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References and documents

Individual participant data

Plan to share: No — Following publication of study results, de-identified patient data will be made available upon reasonable request

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2021 (actual). Primary completion is estimated for Jun 2030, 111 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2022
First posted
Feb 25, 2022
StartActual
Mar 3, 2021
Primary completionEst.
Jun 30, 2030
CompletionEst.
Jun 30, 2030
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05257746
Responsible party
Sponsor
First posted
Feb 25, 2022
Start date
Mar 3, 2021
Primary completion
Jun 30, 2030 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Aug 27, 2026

Study contacts

Johannes Fritzmann, Dr.
Contact
johannes.fritzmann@ukdd.de
+49 351 458 19477
Johannes Fritzmann, Dr.
principal investigator · Technische Universität Dresden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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