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

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 Overview

• Status: Recruiting
• Conditions: Rectal Surgery
• Intervention / Treatment: Procedure: Rectal resection

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Johannes Fritzmann, Dr.; Phone Number: +49 351 458 19477; Email: johannes.fritzmann@ukdd.de

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
      • Contact: Johannes Fritzmann, Dr.; Phone Number: +49 351 458 19477; Email: johannes.fritzmann@ukdd.de
      • Sub-Investigator: Fiona Kolbinger, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients undergoing rectal resection with total mesorectal excision

Description

Inclusion Criteria:

• Patients undergoing rectal resection with total mesorectal excision

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative hospital stay [days]	Postoperative day 1 until day of discharge	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	At day of discharge, assessed up to 90 days
Operating time [min]	Time from skin incision until placement of last skin staple/suture.	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	during surgery
Frequency of peri-operative morbidity after resection	Frequency of peri-operative complications after resection	90 days after surgery
Kind of peri-operative morbidity after resection	Kind of peri-operative complications after resection	90 days after surgery

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Principal Investigator: Johannes Fritzmann, Dr., Technische Universität Dresden

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Digestive System Surgical Procedures; Surgical Procedures, Colorectal; Proctectomy
• Other Study ID Numbers: VTG-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Following publication of study results, de-identified patient data will be made available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No