Rectal Neoplasms Clinical Trial
Official title:
Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision
The purpose of this research protocol is the evaluation of the improvement of the anorectal and urogenital urinary function, alongside the postoperative quality of life after the application of pIONM in patients submitted to TME for rectal cancer.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | September 19, 2027 |
Est. primary completion date | September 19, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Histologically confirmed rectal cancer - Surgical resection with TME - <90 years old - Signed informed consent Exclusion Criteria: - Emergency operation - Presence of pacemaker - Partial mesorectal excision - Sepsis or systematic infection - Physical or mental impairment - Pregnancy or nursing - Insufficient preoperative data for the urogenital/ anorectal function - Lack of compliance with the research process |
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Larissa | Larissa |
Lead Sponsor | Collaborator |
---|---|
Larissa University Hospital | General Hospital of Larissa, University of Thessaly |
Greece,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the quality of life of the patient at 3 months postoperatively, based on the SF-36 questionnaire | Change in the quality of life of the patient, at 3 months postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire SF-36: Short Form Survey Minimum Value: 0 Maximum Value: 100 Higher scores indicate a better outcome | Preoperatively, 3 months postoperatively | |
Secondary | Operative time | The total operative time will be recorded. Measurement unit: minutes | Intraoperative period | |
Secondary | Intraoperative bleeding | The total intraoperative blood loss volume will be recorded. Measurement unit: mL | Intraoperative period | |
Secondary | Postoperative discharge time | Postoperative time that the patient can be safely discharged. Measurement unit: hours. The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfil the Clinical Discharge Criteria. More specifically, the patient should meet the following : steady vital signs, be oriented, without nausea or vomiting, mobilized with a steady gait, without a significant bleeding | Maximum time frame 15 days postoperatively | |
Secondary | Postoperative complications | Occurrence of postoperative complications (based on Clavien-Dindo classification). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 1 month postoperatively | |
Secondary | Negative resection margin | Occurrence of negative resection margin. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 1 month postoperatively | |
Secondary | Local recurrence | Occurrence of local recurrence. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 1 year postoperatively | |
Secondary | Bladder capacity | Urodynamic assessment. Evaluation of bladder capacity. Measurement unit: ml | Preoperatively and 2 months postoperatively | |
Secondary | Bladder compliance | Urodynamic assessment. Evaluation of bladder compliance. Measurement unit: ml/cm H2O | Preoperatively and 2 months postoperatively | |
Secondary | Detrusor pressure at maximum flow | Urodynamic assessment. Evaluation of detrusor pressure at maximum flow. Measurement unit: cm H2O | Preoperatively and 2 months postoperatively | |
Secondary | Maximum urinary flow rate | Urodynamic assessment. Evaluation of maximum urinary flow rate. Measurement unit: ml/s | Preoperatively and 2 months postoperatively | |
Secondary | Voiding volume | Urodynamic assessment. Evaluation of voiding volume. Measurement unit: ml | Preoperatively and 2 months postoperatively | |
Secondary | Post-void residual | Urodynamic assessment. Evaluation of post-void residual. Measurement unit: ml | Preoperatively and 2 months postoperatively | |
Secondary | Anal canal resting phase pressure | High-resolution Anorectal Manometry assessment. Evaluation of anal canal resting phase pressure. Measurement unit: mmHg | Preoperatively and 2 months postoperatively | |
Secondary | Sphincter zone length | High-resolution Anorectal Manometry assessment. Evaluation of sphincter zone length. Measurement unit: cm | Preoperatively and 2 months postoperatively | |
Secondary | Short squeeze test | High-resolution Anorectal Manometry assessment. Evaluation of short squeeze (5sec) pressure. Measurement unit: mmHg | Preoperatively and 2 months postoperatively | |
Secondary | Long squeeze test | High-resolution Anorectal Manometry assessment. Evaluation of long squeeze (30sec) pressure. Measurement unit: mmHg | Preoperatively and 2 months postoperatively | |
Secondary | Cough test | High-resolution Anorectal Manometry assessment. Evaluation of cough test (0 and 50 ml). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | Preoperatively and 2 months postoperatively | |
Secondary | Push test | High-resolution Anorectal Manometry assessment. Evaluation of push test (0 and 50 ml). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | Preoperatively and 2 months postoperatively | |
Secondary | RAIR test | High-resolution Anorectal Manometry assessment. Evaluation of rectoanal inhibitory reflex (RAIR) test (20 and 50 ml). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | Preoperatively and 2 months postoperatively | |
Secondary | Difference in the quality of life of the patient, based on the SF-36 questionnaire | Difference in the quality of life of the patient, at 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire SF-36: Short Form Survey Minimum Value: 0 Maximum Value: 100 Higher scores indicate a better outcome | Preoperatively, 6, 12, 24 months postoperatively | |
Secondary | Difference in the erectile function of the patient, based on the IIEF questionnaire | Difference in the erectile function of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the International Index of Erectile Function (IIEF) questionnaire IIEF: International Index of Erectile Function Minimum Value: 0 Maximum Value: 5 Higher scores indicate a better outcome | Preoperatively, 3, 6, 12, 24 months postoperatively | |
Secondary | Difference in the sexual function of the patient, based on the FSFI questionnaire | Difference in the sexual function of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the Female Sexual Function Index (FSFI) questionnaire FSFI: Female Sexual Function Index Minimum Value: 2 Maximum Value: 36 Higher scores indicate a better outcome | Preoperatively, 3, 6, 12, 24 months postoperatively | |
Secondary | Difference in the prostate symptoms of the patient, based on the IPSS questionnaire | Difference in the prostate symptoms of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the International Prostate Symptom Score (IPSS) questionnaire IPSS: International Prostate Symptom Score Minimum Value: 0 Maximum Value: 35 Higher scores indicate a worse outcome | Preoperatively, 3, 6, 12, 24 months postoperatively | |
Secondary | Difference in the low anterior syndrome symptoms of the patient, based on the LARS questionnaire | Difference in the low anterior syndrome symptoms of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the Low Anterior Resection Syndrome (LARS) questionnaire LARS: Low Anterior Resection Syndrome Minimum Value: 0 Maximum Value: 42 Higher scores indicate a worse outcome | Preoperatively, 3, 6, 12, 24 months postoperatively |
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