Acupuncture for Postoperative Urinary Retention After Hemorrhoidectomy: a Randomized Controlled Trial

NCT ID: NCT05898919

Last Updated: 2023-07-10

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-07-06

Brief Summary

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The goal of this study is to examine the efficacy of acupuncture in the management of acute postoperative urinary retention.

Clinical question:

Is acupuncture efficacious for postoperative urinary retention after hemorrhoidectomy compared with sham acupuncture and neostigmine.

Study design:

The participants who undergo hemorrhoidectomy and report postoperative urinary retention will receive one session of acupuncture or sham acupuncture or one injection of 1-mg neostigmine. The primary outcome was the time to first urination after surgery.

Detailed Description

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Conditions

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Postoperative Complications Postoperative Urinary Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Acupuncture is a technique that inserts a needle into the acupuncture point to treat a condition. In this trial, we will use acupuncture to treat postoperative urinary retention.

Sham acupuncture

Group Type PLACEBO_COMPARATOR

Sham acupuncture

Intervention Type OTHER

Participants will receive sham acupuncture at sham points.

Neostigmine

Group Type ACTIVE_COMPARATOR

Neostigmine Injectable Product

Intervention Type DRUG

Neostigmine was injected once after postoperative urinary retention.

Interventions

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Acupuncture

Acupuncture is a technique that inserts a needle into the acupuncture point to treat a condition. In this trial, we will use acupuncture to treat postoperative urinary retention.

Intervention Type OTHER

Sham acupuncture

Participants will receive sham acupuncture at sham points.

Intervention Type OTHER

Neostigmine Injectable Product

Neostigmine was injected once after postoperative urinary retention.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged between 18 and 65 years
* Meets the diagnostic criteria of postoperative urinary retention
* Received milligan-morgan hemorrhoidectomy and general anesthesia

Exclusion Criteria

* Received Diuretic drugs
* Organic diseases that cause urinary retention
* Severe infection in the urinary tract
* Has a history of adverse reaction to neostigmine
* Cognitive dysfunction that affects outcome assessment
* Being pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hui Zheng

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital of Chengdu University of Traditional Chinese Medicine

Locations

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Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, , China

Site Status

Countries

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China

Other Identifiers

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HCDUTCM_2022056

Identifier Type: -

Identifier Source: org_study_id

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