Bowel Preparation Before Hemorrhoidectomy

May 4, 2024 updated by: Bediye Öztaş, Saglik Bilimleri Universitesi

Effect of Two Different Bowel Preparation Methods on Outcomes After Hemorrhoidectomy

The purpose of this research; To evaluate the effect of preoperative bowel preparation on post-hemorrhoidectomy outcomes. Bowel preparation is a routine practice before surgery in anorectal diseases. This study aims to evaluate the effect of bowel preparation using laxatives or enemas on the patient postoperative pain, analgesic consumption amount, comfort, first defecation time and satisfaction, and to evaluate the satisfaction of the surgical team.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The study is planned as a semi-experimental. The effect of bowel preparation using laxatives or enemas on postoperative pain, analgesic consumption, comfort and satisfaction will be evaluated. Criteria for inclusion in the research; Being a patient who will undergo hemorrhoidectomy with spinal anesthesia and agreeing to participate in the study are the exclusion criteria; Refusal to participate in the research was determined as. Following the admission of the patient, who is planned to undergo hemorrhoidectomy, to the clinic, the patient will be interviewed, the purpose of the study will be explained and he/she will be invited to participate in the study. Written consent will be obtained from patients who agree to participate in the research.

Study Type

Interventional

Enrollment (Estimated)

60

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 Locations

  • Turkey
      • Ankara, Turkey, 06280
        • Sağlık Bilimleri Üniversitesi

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:

  • Being a patient who will undergo hemorrhoidectomy surgery with spinal anesthesia
  • Agreeing to participate in the study

Exclusion Criteria:

  • Not accepting participation in the study

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group that will undergo bowel preparation using laxatives (Two bowel X-M Solution 250 ml.)
Bowel preparation will be made using a laxative (Two bowel X-M Solution 250 ml.)
Drug: Group that will undergo bowel preparation using laxatives (Two bowel X-M Solution 250 ml.)
A laxatives (Two bowel X-M Solution 250 ml.) will be applied for bowel preparation before hemorrhoidectomy. The drug was given to the patient at 3 o'clock (p.m.)before the surgery by mixing it with 1500ml of water.
Experimental: Group that will undergo bowel preparation using enema (Two bowel E.S. Enema )
Bowel preparation will be made using enema (Two bowel E.S. Enema )
Drug: Group that will undergo bowel preparation using enema (Two bowel E.S. Enema )
An enema (Two bowel E.S. Enema ) will be applied for bowel preparation before hemorrhoidectomy.The drug was administered to the patient at 00 o'clock (a.m.) and 06 o'clock (a.m.) before the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: postoperative 2, 6, 10, 20, 24. hours and at the first defecation assessed up to 72 hours
To evaluate pain; A numerical rating scale will be used, numbered 0-10, 0: no pain, 10: unbearable pain (1-3 mild, 4-6 moderate, 7-10 severe).
postoperative 2, 6, 10, 20, 24. hours and at the first defecation assessed up to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic consumption amount
Time Frame: First 24 hours postoperatively
Total amount of analgesic used in the first 24 hours postoperatively
First 24 hours postoperatively
Comfort level
Time Frame: It will be evaluated once at the 24th postoperative hour.

To evaluate comfort; Perianesthesia comfort scale will be used.Perianesthesia Comfort Scale (PCS) consists of 24 items that reflect the individual's general thought process about the perianesthesia period and question his/her self-conception and feelings.

Each statement in the scale has a Likert-type scoring ranging from 1-6, from "strongly disagree" to "strongly agree".

The highest total score that can be obtained from the scale is 144, and the lowest total score is 24.

The average value is determined by dividing the total score obtained by the number of scale items and the result is stated in the 1-6 distribution.

A low score indicates poor comfort and a high score indicates good comfort.
It will be evaluated once at the 24th postoperative hour.
Satisfaction level of patients
Time Frame: It will be evaluated once at the 24th postoperative hour.
To evaluate the satisfaction of patients and the surgical team; A numerical evaluation scale (numbered between 0-10, 0: not at all satisfied, 10: very satisfied) will be used.
It will be evaluated once at the 24th postoperative hour.

Collaborators and Investigators

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

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: bediye oztas, phd, Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

April 20, 2024

First Submitted That Met QC Criteria

May 4, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 4, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 913715751

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing will be possible when the work is published.

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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