MedDataX Logo

Comparison Study of the Effect of Enema in Anal Surgery

NCT ID: NCT05602987

Last Updated: 2023-11-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

For patients undergoing anal surgery, some of them receive enema as doctors' preference before the surgery in consider to lower postoperative complications e.g. infection, while others do not. These choices are often determined by surgeons' personal preference according to their experiences due to lack of evidence from researches. Hemorrhoidectomy and fistulotomy are the most common two types of surgery in colon and rectal surgery division in Shuang Ho hospital, where top three quantities of hemorrhoidectomy in Taiwn have been performed.Therefore, we conducted a randomized controlled trial to evaluate the benefits of enema before anal surgery and possible waste of medical resources.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemorrhoids Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Group: enema

receiving enema at the night before anal surgery

Group Type EXPERIMENTAL

enema

Intervention Type PROCEDURE

receiving enema at the night before anal surgery

Control Group: no enema

no enema before anal surgery

Group Type ACTIVE_COMPARATOR

no enema

Intervention Type PROCEDURE

no enema before anal surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

enema

receiving enema at the night before anal surgery

Intervention Type PROCEDURE

no enema

no enema before anal surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy
* Patients who underwent fistulotomy or fistulectomy

Exclusion Criteria

* Emergency surgery
* Surgery other than circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy, e.g., rubber band ligation, injection treatment, and cryosurgery
* Complicated fistulectomy, e.g., requiring surgical drainage and seton placement
* Other types of anal surgery, e.g., anal fissure and colorectal cancer
* Liver cirrhosis
* Coagulation dysfunction
* Bedridden
* Human immunodeficiency virus infection
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tungcheng Chang, MD, PhD

Chief of Colorectal Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tung Cheng Chang, MD, PHD

Role: STUDY_DIRECTOR

Taipei Medical University Shuang Ho Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Medical University Shuang-Ho Hospital

New Taipei City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N202209016

Identifier Type: -

Identifier Source: org_study_id