CClinicalTrials.gg
Enrolling by invitationNCT06403774Updated May 8, 2024

Bowel Preparation Before Hemorrhoidectomy

An interventional study of Group that will undergo bowel preparation using laxatives (Two bowel X-M Solution 250 ml.) and Group that will undergo bowel preparation using enema (Two bowel E.S. Enema ) in HEMORRHOIDECTOMY, sponsored by Saglik Bilimleri Universitesi. Enrolling by invitation at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 4 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 9 months after the study started (first participant enrolled Jul 2023, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HEMORRHOIDECTOMY

Keywords

  • HEMORRHOIDECTOMY
  • BOWEL PREPARATION
  • PAIN
  • COMFORT
03

In context

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not accepting participation in the study
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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.)

  • 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 )

Interventions

  • DrugGroup 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.

  • DrugGroup 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.

06

What researchers measure

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).

    Time frame: postoperative 2, 6, 10, 20, 24. hours and at the first defecation assessed up to 72 hours

Secondary outcomes

  1. Analgesic consumption amount

    Total amount of analgesic used in the first 24 hours postoperatively

    Time frame: First 24 hours postoperatively

  2. 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.

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

  3. 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.

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

07

Study locations

1 site
  • Sağlık Bilimleri Üniversitesi
    Ankara, 06280, Turkey
08

References and documents

Publications

  • • 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. PubMed 27766395 ↗

Individual participant data

Plan to share: No — Sharing will be possible when the work is published.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06403774
Lead sponsor
Saglik Bilimleri Universitesi
Responsible party
Bediye Öztaş (Principal investigator, Saglik Bilimleri Universitesi) — Principal investigator
First posted
May 8, 2024
Start date
Jul 1, 2023
Primary completion
May 30, 2024 (estimated)
Completion
May 30, 2024 (estimated)
Last update
May 8, 2024

Study contacts

bediye oztas, phd
principal investigator · nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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