Bowel Preparation Before Hemorrhoidectomy

NCT06403774 | Enrolling By Invitation

• 1 other identifier: 913715751
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HEMORRHOIDECTOMY

Keywords

HEMORRHOIDECTOMY; BOWEL PREPARATION; PAIN; COMFORT

Outcome Measures

Primary Outcomes (1)

• Pain level

  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 Outcomes (3)

• Analgesic consumption amount

  First 24 hours postoperatively

• Comfort level

  It will be evaluated once at the 24th postoperative hour.

• Satisfaction level of patients

  It will be evaluated once at the 24th postoperative hour.

Study Arms (2)

Group that will undergo bowel preparation using laxatives (Two bowel X-M Solution 250 ml.)

EXPERIMENTAL

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.)

Group that will undergo bowel preparation using enema (Two bowel E.S. Enema )

EXPERIMENTAL

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 )

Interventions

Group that will undergo bowel preparation using laxatives (Two bowel X-M Solution 250 ml.) DRUG

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.

Group that will undergo bowel preparation using laxatives (Two bowel X-M Solution 250 ml.)

Group that will undergo bowel preparation using enema (Two bowel E.S. Enema ) DRUG

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.

Group that will undergo bowel preparation using enema (Two bowel E.S. Enema )

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not accepting participation in the study

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Ankara, 06280, Turkey (Türkiye)

Location

Related Publications (2)

• • De la Garza M.,.Counihan T.C. Complications of hemorrhoid surgery. Seminars in Colon and Rectal Surgery 24 (2013) 96-102

  BACKGROUND

• Sammour T, Barazanchi AW, Hill AG; PROSPECT group (Collaborators). Evidence-Based Management of Pain After Excisional Haemorrhoidectomy Surgery: A PROSPECT Review Update. World J Surg. 2017 Feb;41(2):603-614. doi: 10.1007/s00268-016-3737-1.

  PMID: 27766395 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• bediye oztas, phd

  nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: TWO DIFFERENT BOWEL PREPARATION METHODS WILL BE COMPARED IN PATIENTS WHO WILL HAVE HEMORRHOIDECTOMY

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: May 8, 2024
• Study Start: July 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)