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Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision

ConditionRectal Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorLarissa University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Histologically confirmed rectal cancer

Surgical resection with TME

<90 years old

Signed informed consent

Disqualifiers

Emergency operation

Presence of pacemaker

Partial mesorectal excision

Sepsis or systematic infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pelvic Intraoperative Neuromonitoring

    Other intervention

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

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: pIONMExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Preoperatively, 3 months postoperatively

Secondary outcomes

1

Operative time

The total operative time will be recorded. Measurement unit: minutes

Time frame
Intraoperative period
2

Intraoperative bleeding

The total intraoperative blood loss volume will be recorded. Measurement unit: mL

Time frame
Intraoperative period
3

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

Time frame
Maximum time frame 15 days postoperatively
4

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'

Time frame
1 month postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Larissa University Hospital

Lead sponsor

General Hospital of Larissa

Collaborator

University of Thessaly

Collaborator

Source ClinicalTrials.gov
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