Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision

• ClinicalTrials.gov Identifier: NCT04949646
• Recruitment Status: Recruiting
• First Posted: July 2, 2021
• Last Update Posted: March 13, 2024
• Sponsor: Larissa University Hospital
• Collaborators: General Hospital of Larissa; University of Thessaly
• Information provided by (Responsible Party): Perivoliotis Konstantinos, Larissa University Hospital

Study Description

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

Detailed Description:

The introduction of Total Mesorectal Excision (TME) resulted to the improvement of the overall survival and local recurrence rates of rectal cancer patients. However, the associated urogenital and anorectal functional deficit has a significant effect on the postoperative quality of life of the patient. More specifically, the postoperative rates of urogenital and sexual dysfunction that have been reported in the various series, are estimated at the levels of 70% and 90%, respectively. Additionally, TME is associated with the development of the low anterior syndrome (LARS). LARS is characterized by the onset of fecal incontinence, due to injury in the autonomic nerve plexuses that innervate the internal anal sphincter (IAS); who in turn is responsible for the 52-85% anal resting tone. According to a recent study, 38.8% and 33.7% of patients with normal preoperative urogenital function, developed postoperative stool and urine incontinence, respectively.

It becomes apparent that the incidence rates of these complications vary between the various series, mainly due to their small sample size, the lack of comparative data, the short follow up period, the use of non-validated tools and their retrospective design. Several predictive factors of these adverse events have been suggested in the literature, including old age, tumors located less than 12 cm from the anal verge, preoperative radiotherapy and injury to the pelvic autonomous nerves.

The clinical and functional anatomy of the pelvis are quite complex. The inferior hypogastric plexus is formed by the parasympathetic pelvic nerves, deriving from the I2-I4 and the sympathetic hypogastric nerve. It is a neural anatomic structure that carries organ-specific nerve fibers. Visual identification of the plexus is quite difficult, for various reasons, including the complexity of the nerve distribution, the narrow pelvis, the voluminous mesorectum, obesity, previous pelvic operations, neoadjuvant radiotherapy, locally advanced tumors, intraoperative bleeding and the extensive use of diathermy. According to the current literature, identification of the autonomous pelvic plexus is achievable in 72% of cases, whereas partial localization is possible only in 10.7% of patients.

Theoretically, intraoperative neuromonitoring of the pelvic autonomous nerves (pIONM), could quantify intraoperative nerve injuries, while in parallel, contribute to the improvement of the patients' postoperative quality of life. Several pIONM techniques have been described, including intra-urethral and intra-vesical pressure measurements. However, it was found that intermittent neuromonitoring objectifies the macroscopic integrity assessment of the sacral plexus. Recently, a promising technique, based on the simultaneous electromyography of the IAS and bladder manometry was developed, with encouraging results. During pIONM, the surgeon delivers electric stimuli to the autonomic nerve structures through a hand-held stimulator. At the same time, electromyogram changes of the IAS and the external anal sphincter (EAS), alongside intravesical pressure gradients are assessed.

Intraoperative neuromonitoring has been evaluated in several experimental studies. In a recent study, intraoperative simulation of the inferior hypogastric plexus with a bipolar stimulator resulted to the appearance of a measurable and repeatable electromyographic signal from the IAS.

Simultaneous signal processing from the IAS and urinary bladder, improves the, overall, diagnostic accuracy of these techniques. Stabilization of the electrodes outside the surgical field, has been, also, suggested by some researchers. Additionally, experimental studies evaluated the role of pIONM in the minimal invasive TME.

Moreover, the effectiveness of this technique has been a research subject in multiple clinical trials. In another study, where 85 patients underwent TME, after logistic regression, no use of pIONM and neoadjuvant radiotherapy, were identified as independent prognostic factors of postoperative urogenital deficit. Furthermore, the use of pIONM, was associated with a 100% sensitivity and a 96% specificity for the postoperative development of urogenital and anorectal functional complications.

The application of pIONM has been also suggested in the laparoscopic and robotic TME, using specially designed stimulators. In another trial, preservation of the plexus was achieved in 51.7% of patients submitted to a laparoscopic low anterior resection for rectal cancer. During one year follow-up, patients receiving pIONM, displayed a superiority in terms of postoperative urogenital function, as assessed by the IIEF, IPSS and FSFI questionnaires.

Study Design

• 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, 2026
• Estimated Study Completion Date: September 19, 2027

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Konstantinos Tepetes, Prof; 00302413502804; tepetesk@gmail.com

Contact: Konstantinos Perivoliotis, MD; 00302413501000; kperi19@gmail.com

Locations

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

• 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

More Information

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
• Last Update Posted: March 13, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plan to share individual patient data

• 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:

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases