HEMORRHOIDECTOMYNCT06403774
Bowel Preparation Before Hemorrhoidectomy
A study testing 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 people with HEMORRHOIDECTOMY, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HEMORRHOIDECTOMY
- What is being tested?
- 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 )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a patient who will undergo hemorrhoidectomy surgery with spinal anesthesia
- Agreeing to participate in the study
Who cannot join
- Not accepting participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- HEMORRHOIDECTOMY
- Being tested
- 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 )
- Keywords
- HEMORRHOIDECTOMY, BOWEL PREPARATION, PAIN, COMFORT
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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 ) Receives: Drug: Group that will undergo bowel preparation using enema (Two bowel E.S. Enema ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: postoperative 2, 6, 10, 20, 24. hours and at the first defecation assessed up to 72 hours
Secondary outcomes (3)
Analgesic consumption amount
Total amount of analgesic used in the first 24 hours postoperatively
Measured: First 24 hours postoperatively
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.
Measured: It will be evaluated once at the 24th postoperative hour.
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.
Measured: It will be evaluated once at the 24th postoperative hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jul 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HEMORRHOIDECTOMYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TWO DIFFERENT BOWEL PREPARATION METHODS WILL BE COMPARED IN PATIENTS WHO WILL HAVE HEMORRHOIDECTOMY
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bediye Öztaş, Saglik Bilimleri Universitesi
- Investigators
- bediye oztas, phd, Principal investigator, nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403774
- Sponsor's protocol ID
- 913715751
- Status last verified
- May 2024
- First submitted
- 20 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing will be possible when the work is published.
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Bowel Preparation Methods on Outcomes After Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT06403774
- Acronym / sponsor ID
- 913715751
- Conditions
- HEMORRHOIDECTOMY
- Keywords
- HEMORRHOIDECTOMY, BOWEL PREPARATION, PAIN, COMFORT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- TWO DIFFERENT BOWEL PREPARATION METHODS WILL BE COMPARED IN PATIENTS WHO WILL HAVE HEMORRHOIDECTOMY
| Arm | Type | Receives |
|---|---|---|
| Group that will undergo bowel preparation using laxatives (Two bowel X-M Solution 250 ml.) | Experimental | Drug: 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.) |
| Group that will undergo bowel preparation using enema (Two bowel E.S. Enema ) | Experimental | Drug: 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 ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being a patient who will undergo hemorrhoidectomy surgery with spinal anesthesia
- Agreeing to participate in the study
Key exclusion criteria (1 listed)
- Not accepting participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | 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 )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. | Drug | Group that will undergo bowel preparation using enema (Two bowel E.S. Enema ) |
Primary outcome
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).
3 secondary outcomes
Analgesic consumption amount
Time frame: First 24 hours postoperatively
Comfort level
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background• De la Garza M.,.Counihan T.C. Complications of hemorrhoid surgery. Seminars in Colon and Rectal Surgery 24 (2013) 96-102
- Background: PubMed 27766395Sammour 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.
- Individual participant dataSharing planned: No. Sharing will be possible when the work is published.
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The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
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Laser Hemorrhoidoplasty Versus Open Hemorrhoidectomy for Postoperative Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bediye oztas, phd principal investigator
nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with HEMORRHOIDECTOMY, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: postoperative 2, 6, 10, 20, 24. hours and at the first defecation assessed up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403774, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.