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Functional Outcome of Organ Preservation After Neo-adjuvant Chemo Radiation for Rectal Cancer

NCT02278653 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-09-18

No results posted yet for this study

Summary

The primary objective is to describe the functional outcome of patients that choose for organ saving treatment.

Conditions

  • Rectal Neoplasms

Interventions

OTHER

Questionnaires for the evaluation of Quality of Life

1. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score 2. Short Form (36) health survey 3. EORTC CR38 4. Vaizey score 5. Low Anterior Resection Syndrome (LARS) score 6. International Index of Erectile Function for men 7. International Prostate Symptom Score for men 8. Female Sexual Function Index for women

OTHER

Manometry

Manometry is a tool to measure the anal sphincter function. Patients do not need any bowel preparation before this procedure. During the examination a catheter tip will be positioned in the rectum above the sphincter and a small balloon will be inflated. This balloon is connected to a device that registers the measurements. Patients will receive instructions; e.g. squeeze, push, and cough. The procedure takes approximately 10 minutes and is not experienced as painful. Several parameters will be measured: the mean basal pressure, the maximum squeeze pressure, first sensation, first urge to defecate and the maximum tolerable volume. The manometric measurement will take place on the same day as the endoscopy and MRI (standard follow-up).

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Geerard L Beets, MD, PhD · Surgery, MUMC+

  • Rianne CJ Beckers, MD, MSc · Surgery/Radiology MUMC+

  • Miriam M van Heeswijk, MD, MSc · Surgery/Radiology MUMC+

  • Monique Maas, MD, PhD · Radiology, MUMC+

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-10-31
Completion
2022-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02278653 on ClinicalTrials.gov