Bowel Preparation Before Hemorrhoidectomy

HEMORRHOIDECTOMY Clinical Trial

Official title:

Effect of Two Different Bowel Preparation Methods on Outcomes After Hemorrhoidectomy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06403774
• Other study ID #: 913715751
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HEMORRHOIDECTOMY

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Üniversitesi	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analgesic consumption amount	Total amount of analgesic used in the first 24 hours postoperatively	First 24 hours postoperatively
Secondary	Comfort level	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.
Secondary	Satisfaction level of patients	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.