Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors

October 7, 2023 updated by: Jianbin Xiang, Huashan Hospital

Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors

To investigate the effects of intersphincteric resection (ISR) of ultra-low rectal tumor on the brain-rectoanal function of patients, and to precisely localize the cerebral functional regulatory regions for intervention targets of anorectal remodeling. Utilizing transcranial magnetic stimulation(TMS) technology to explore the functional remodeling of the "new" anorectal muscle groups and provide a theoretical basis for more research on the rehabilitation and mechanism of fecal incontinence.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a Single-center Phase II, Open, Three-Arm clinical trial. We prospectively enroll patients who undergo ISR for ultra-low rectal tumor in the department of General Surgery, Huashan Hospital, Fudan University. Patients with ileostomy closure are randomly divided into two groups (TMS group and false stimulation group), and healthy volunteers were recruited. The differences of task-state fMRI between healthy volunteers, and ISR patients (both preoperative and postoperative) are compared, combined with rectal function scores (Wexner score, LARS score) and quality of life scale (EORTC QLQ-C30, EORTC QLQ-CR38). Proctoanal manometry are used to find the precise location of the proctoanal motor function area in the cerebral cortex, and to evaluate the effect and value of TMS on postoperative anorectal motor function remodeling in patients with ISR.

Study Type

Interventional

Enrollment (Estimated)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital Affiliated to Fudan University
        • Contact:
          • Jianbin Xiang, doctor
          • Phone Number: 86-21-52887040
          • Email: 68875417@qq.com
        • Contact:
          • Minwei Zhou, doctor
          • Phone Number: 86-21-52887040
          • Email: zmwf1@126.com
        • Principal Investigator:
          • Jianbin Xiang, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primary ultra-low rectal tumor patient who is received intersphincteric resection and preventive ileostomy was performed.
  • Patient who is willing to participate in the study, and voluntarily sign informed consent.

Exclusion Criteria:

  • Anastomotic leakage or other serious complications occur after surgery.
  • Advanced tumor, tumor recurrence or metastasis.
  • Patients with contraindications of fMRI scanning, such as history of metal implants in the body, claustrophobia, etc.
  • Patients with contraindications for TMS treatment, such as intracranial metal implants, epilepsy history, heart disease with unstable heart function, retinal detachment, etc.
  • Combined with organic brain disease and drug abuse history.
  • Combined with other mental diseases.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Stimultion Group
Patients on the Sham stimulation group will be interfered with the stimulation coil perpendicular to the skull, so that they will hear the sound of machine without having therapeutic effects. The parameters will be the same as those in the stimulation group.
Device: Sham Transcranial magnetic stimulationt
The magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla. Patients on the Sham stimulation group will be interfered with the stimulation coil perpendicular to the skull, so that they will hear the sound of machine without having therapeutic effects. The parameters will be the same as those in the stimulation group.
Active Comparator: Pre-ileostomy-closure Stimultion Group
Patients on the Pre-ileostomy-closure group will be interfered with stimulation 3 weeks before the procedure of ileostomy closure.
Device: Transcranial magnetic stimulation
The magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla.Stimulation group: Intermittentpulse transcranial magnetic stimulation (iTBS) will be performed with : the cluster consists of 3 pulses, the intra-cluster frequency is 50Hz, the intercluster frequency is 5Hz, the interval is 8.2s for every stimulus. There are 20 cycles and a total of 600 pulses. Each intervention time is 3min11s, and the stimulation intensity is set as 80% resting state motion threshold. The intervention will be performed once a day for 2 weeks.
Active Comparator: Post-ileostomy-closure Stimultion Group
Patients on the Post-ileostomy-closure group will be interfered with stimulation 3 weeks after the procedure of ileostomy closure.
Device: Transcranial magnetic stimulation
The magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla.Stimulation group: Intermittentpulse transcranial magnetic stimulation (iTBS) will be performed with : the cluster consists of 3 pulses, the intra-cluster frequency is 50Hz, the intercluster frequency is 5Hz, the interval is 8.2s for every stimulus. There are 20 cycles and a total of 600 pulses. Each intervention time is 3min11s, and the stimulation intensity is set as 80% resting state motion threshold. The intervention will be performed once a day for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The differences of cortical activated areas in task-state fMRI in ISR patients.
Time Frame: pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure.
Cortical activated areas in BOLD sequence of patients in different time frame
pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure.
The differences of cortical activated areas in task-state fMRI between health volunteers and postoperative ISR patients.
Time Frame: 12 month after ileostomy closure。
Cortical activated areas in BOLD sequence of health volunteers and patients
12 month after ileostomy closure。
Rectal function scores (Wexner score)
Time Frame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
Wexner score of patients in different time frame
pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
Rectal function scores (LARS score)
Time Frame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
LARS score of patients in different time frame
pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
Quality of life Scale (EORTC QLQ-C30)
Time Frame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
EORTC QLQ-C30 of patients in different time frame
pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
Quality of life Scale (EORTC QLQ-CR38)
Time Frame: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
EORTC QLQ-CR38 of patients in different time frame
pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proctoanal manometry
Time Frame: pre-ISR，3 , 6, 12, 18, 24 month after ileostomy closure.
Proctoanal manometry of Patients in different time frame
pre-ISR，3 , 6, 12, 18, 24 month after ileostomy closure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Study Chair: Jianbin Xiang, PhD, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

October 7, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-087

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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