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Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04949646
Recruitment Status : Recruiting
First Posted : July 2, 2021
Last Update Posted : December 28, 2022
Sponsor:
Collaborators:
General Hospital of Larissa
University of Thessaly
Information provided by (Responsible Party):
Perivoliotis Konstantinos, Larissa University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Other: Pelvic Intraoperative Neuromonitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will employ a prospective, parallel randomized-controlled design
Masking: Single (Participant)
Masking Description: The patient will be blinded regarding the allocation group. Blinding will not exist at the level of the surgeon, the anaesthesiologist, and the investigator responsible for the data recording
Primary Purpose: Treatment
Official Title: Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision
Actual Study Start Date : September 19, 2021
Estimated Primary Completion Date : September 19, 2024
Estimated Study Completion Date : September 19, 2025

Arm Intervention/treatment
Experimental: pIONM

In the experimental group pIONM will be performed intraoperatively. For the implementation of pIONM, a special device, that allows simultaneous monitoring of sphincter signals and bladder manometry, will be introduced. This device will employ the placement of a bipolar electrode in the internal and external anal sphincter. Moreover, another electrode will be placed on the surrounding tissues. For bladder manometry, the catheter will be connected to the pressure sensor, and subsequently to the pIONM monitor. Intraoperatively, depending on the approach (open or laparoscopic), the respective bipolar stimulator will be used.

Prior to the initiation of pIONM, urinary bladder will be drained and filled with 200 ml R/L. The pIONM parameters will be the following: 1-25 milliampere current, 30 Hz frequency and 200 μs monophasic pulses.

Other: Pelvic Intraoperative Neuromonitoring
Pelvic Intraoperative Neuromonitoring (pIONM) allows mapping of the pelvic autonomous plexus during total mesorectal excision (TME).

No Intervention: Control
In the control group pIONM will not be performed intraoperatively



Primary Outcome Measures :
  1. Change in the quality of life of the patient at 3 months postoperatively, based on the SF-36 questionnaire [ Time Frame: Preoperatively, 3 months postoperatively ]
    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


Secondary Outcome Measures :
  1. Operative time [ Time Frame: Intraoperative period ]
    The total operative time will be recorded. Measurement unit: minutes

  2. Intraoperative bleeding [ Time Frame: Intraoperative period ]
    The total intraoperative blood loss volume will be recorded. Measurement unit: mL

  3. Postoperative discharge time [ Time Frame: Maximum time frame 15 days postoperatively ]
    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

  4. Postoperative complications [ Time Frame: 1 month postoperatively ]
    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'

  5. Negative resection margin [ Time Frame: 1 month postoperatively ]
    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'

  6. Local recurrence [ Time Frame: 1 year postoperatively ]
    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'

  7. Bladder capacity [ Time Frame: Preoperatively and 2 months postoperatively ]
    Urodynamic assessment. Evaluation of bladder capacity. Measurement unit: ml

  8. Bladder compliance [ Time Frame: Preoperatively and 2 months postoperatively ]
    Urodynamic assessment. Evaluation of bladder compliance. Measurement unit: ml/cm H2O

  9. Detrusor pressure at maximum flow [ Time Frame: Preoperatively and 2 months postoperatively ]
    Urodynamic assessment. Evaluation of detrusor pressure at maximum flow. Measurement unit: cm H2O

  10. Maximum urinary flow rate [ Time Frame: Preoperatively and 2 months postoperatively ]
    Urodynamic assessment. Evaluation of maximum urinary flow rate. Measurement unit: ml/s

  11. Voiding volume [ Time Frame: Preoperatively and 2 months postoperatively ]
    Urodynamic assessment. Evaluation of voiding volume. Measurement unit: ml

  12. Post-void residual [ Time Frame: Preoperatively and 2 months postoperatively ]
    Urodynamic assessment. Evaluation of post-void residual. Measurement unit: ml

  13. Anal canal resting phase pressure [ Time Frame: Preoperatively and 2 months postoperatively ]
    High-resolution Anorectal Manometry assessment. Evaluation of anal canal resting phase pressure. Measurement unit: mmHg

  14. Sphincter zone length [ Time Frame: Preoperatively and 2 months postoperatively ]
    High-resolution Anorectal Manometry assessment. Evaluation of sphincter zone length. Measurement unit: cm

  15. Short squeeze test [ Time Frame: Preoperatively and 2 months postoperatively ]
    High-resolution Anorectal Manometry assessment. Evaluation of short squeeze (5sec) pressure. Measurement unit: mmHg

  16. Long squeeze test [ Time Frame: Preoperatively and 2 months postoperatively ]
    High-resolution Anorectal Manometry assessment. Evaluation of long squeeze (30sec) pressure. Measurement unit: mmHg

  17. Cough test [ Time Frame: Preoperatively and 2 months postoperatively ]
    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'

  18. Push test [ Time Frame: Preoperatively and 2 months postoperatively ]
    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'

  19. RAIR test [ Time Frame: Preoperatively and 2 months postoperatively ]
    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'

  20. Difference in the quality of life of the patient, based on the SF-36 questionnaire [ Time Frame: Preoperatively, 6, 12, 24 months postoperatively ]
    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

  21. Difference in the erectile function of the patient, based on the IIEF questionnaire [ Time Frame: Preoperatively, 3, 6, 12, 24 months postoperatively ]
    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

  22. Difference in the sexual function of the patient, based on the FSFI questionnaire [ Time Frame: Preoperatively, 3, 6, 12, 24 months postoperatively ]
    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

  23. Difference in the prostate symptoms of the patient, based on the IPSS questionnaire [ Time Frame: Preoperatively, 3, 6, 12, 24 months postoperatively ]
    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

  24. Difference in the low anterior syndrome symptoms of the patient, based on the LARS questionnaire [ Time Frame: Preoperatively, 3, 6, 12, 24 months postoperatively ]
    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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04949646


Contacts
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Contact: Konstantinos Tepetes, Prof 00302413502804 tepetesk@gmail.com
Contact: Konstantinos Perivoliotis, MD 00302413501000 kperi19@gmail.com

Locations
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Greece
University Hospital of Larissa Recruiting
Larissa, Greece, 41110
Contact: Konstantinos Tepetes, Prof    00302413502804    tepetesk@gmail.com   
Sub-Investigator: Anastasios Manolakis, PhD         
Sub-Investigator: Michael Samarinas, PhD         
Sub-Investigator: Aikaterini Tsiogga, MSc         
Sponsors and Collaborators
Larissa University Hospital
General Hospital of Larissa
University of Thessaly
Investigators
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Study Director: Konstantinos Tepetes, Prof Department of Surgery, University Hospital of Larissa
Principal Investigator: Konstantinos Perivoliotis, MD Department of Surgery, University Hospital of Larissa
  Study Documents (Full-Text)

Documents provided by Perivoliotis Konstantinos, Larissa University Hospital:
Study Protocol  [PDF] June 29, 2021
Informed Consent Form  [PDF] June 29, 2021

Publications:

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Responsible Party: Perivoliotis Konstantinos, Perivoliotis Konstantinos, Principal Investigator, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT04949646    
Other Study ID Numbers: PelIONM
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: December 28, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual patient data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Perivoliotis Konstantinos, Larissa University Hospital:
intraoperative
neuromonitoring
pelvic
autonomous
total
mesorectal
excision
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases