Effect of Pelvic Floor Muscle Electrophysiologic Therapy on Enhanced Recovery After Gynecologic Surgery

NCT ID: NCT03524807

Last Updated: 2018-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-12-31

Brief Summary

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This study is to evaluate the effect of pelvic floor muscle electrophysiologic therapy on enhanced recovery after gynecologic surgery,to solve muscle soreness and retention of urine after laparoscopy, and endometrial repair after electrosurgical resection of intrauterine adhesions.

Detailed Description

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Pelvic floor muscle electrophysiologic therapy is widely used in the treatment of pelvic floor dysfunction diseases at home and abroad. Electrical stimulation can also relieve depression and anxiety and play a sedative effect. In recent years, some studies have shown that pelvic floor electrophysiological therapy can improve the intimal blood flow resistance index of thin endometrium. Therefore, whether or not the pelvic floor electrophysiological therapy can relieve the muscle soreness caused by carbon dioxide retention after endoscopic surgery, reduce the postoperative urinary retention, shorten the postoperative anus exhaust time, and repair the endometrium after the intrauterine adhesion. we expect this electrophysiologic therapy can solve some common postoperative complications and difficult problems, such solve muscle soreness and retention of urine after laparoscopy, and endometrial repair after electrosurgical resection of intrauterine adhesions. Hope to help patients recover quickly after surgery.

Conditions

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Pelvic Floor Muscle Electrophysiologic Therapy Fast-Track Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electrophysiologic therapy group

apply electrophysiologic therapy after surgery

Group Type EXPERIMENTAL

Electrophysiologic therapy

Intervention Type DEVICE

Pelvic floor electrophysiological therapy is used after common gynecologic surgery to record anal exhaust time and micturition time after surgery and endometrium recovery of intrauterine adhesions.For intrauterine adhesions patients, Drug: Aspirin(low dose of Aspirin after operation)Device: intrauterine balloon (insert intrauterine balloon after operation)

non-electrophysiologic therapy group

do not apply electrophysiologic therapy after surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electrophysiologic therapy

Pelvic floor electrophysiological therapy is used after common gynecologic surgery to record anal exhaust time and micturition time after surgery and endometrium recovery of intrauterine adhesions.For intrauterine adhesions patients, Drug: Aspirin(low dose of Aspirin after operation)Device: intrauterine balloon (insert intrauterine balloon after operation)

Intervention Type DEVICE

Other Intervention Names

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pelvic floor muscle electrophysiologic therapy

Eligibility Criteria

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Inclusion Criteria

.After electrocision of intrauterine adhesions;

.Or after common gynecologic laparoscopic surgery,patients occurred muscle pain or patients occurred urinary retention.

Exclusion Criteria

* Pregnancy;
* Suspected acute inflammation of the genitourinary system;
* Postoperative persistent vaginal bleeding;
* Patients have vaginal stenosis;
* Patients have implantation of a pacemaker with a cardiac pacemaker;
* Patients have a malignant pelvic organ tumor; .Patients have nervous system disease (dementia or unstable seizures),who cannot actively cooperate with the treatment.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Yuqing Chen

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuqing Chen, Chief

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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the First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yaling Guo, Master

Role: CONTACT

15622327162

Yuqing Chen, Chief

Role: CONTACT

13724067575

Facility Contacts

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Yaling Guo, Master

Role: primary

15622327162

Yuqing Chen, Chief

Role: backup

13724067575

Other Identifiers

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electrophysiologic treatment

Identifier Type: -

Identifier Source: org_study_id

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