Inflammatory Bowel DiseasesNCT06216223
Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients
A study testing treatment of anal diseases in inflammatory bowel patients, Laser and traditional surgery in people with Inflammatory Bowel Diseases and Anal Fissure, run by Zagazig University at 1 site in Egypt.
Trial summary
This is a randomized comparative clinical trial carried out to compare between laser ablation and surgery in treating anal diseases in inflammatory bowel diseases patients and find out if one is superior to the other. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Anal Fissure, Hemorrhoids
- What is being tested?
- treatment of anal diseases in inflammatory bowel patients, Laser and traditional surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2023to 5 Apr 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with history of inflammatory bowel disease ( non specific colitis, crohn's disease, ulcerative colitis).
- Patients who accidently discovered to have inflammatory bowel disease.
- Age group between 18 to 60 years old
Who cannot join
- Informed consent refusal.
- Proved malignancy in inflammatory bowel disease patients
- Patients less than 18 years old or more than 60 years old
- Contraindications to general and spinal anesthesia
- other types of colitis as ischemic colitis, pseudo-membranous colitis, infective colitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgery Versus Laser Ablation of Anal Diseases in Inflammatory Bowel Disease Patients
This is a randomized comparative clinical trial carried out to compare between laser ablation and surgery in treating anal diseases in inflammatory bowel diseases patients and find out if one is superior to the other.
Inflammatory bowel diseases patients with anal problems were divided into 2 groups, one group had traditional surgery and the other had laser ablation for anal diseases and results were compared between the 2 groups.
- Conditions
- Inflammatory Bowel Diseases, Anal Fissure, Hemorrhoids
- Being tested
- treatment of anal diseases in inflammatory bowel patients, Laser, traditional surgery
- Keywords
- anal fissure, hemorrhoids, inflammatory bowel disease, crohn's disease, ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Fissure in Ano, Hemorrhoids, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment of anal diseases in inflammatory bowel patientsProcedure or surgery
treatment of anal diseases in inflammatory bowel patients
LaserDevice
laser
traditional surgeryProcedure or surgery
traditional surgery
| Study group | Role | What they receive |
|---|---|---|
| laser | Active comparator | laser ablation of anal diseases in inflammatory bowel patients Receives: Procedure: treatment of anal diseases in inflammatory bowel patients; Device: Laser |
| traditional surgery | Sham comparator | traditional surgery for anal diseases in inflammatory bowel patients Receives: Procedure: treatment of anal diseases in inflammatory bowel patients; Procedure: traditional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
operation time in minutes was studied between the 2 groups
Measured: Intraoperative (from skin incision to wound dressing.)
operative bleeding
bleeding in cc was calculated between the 2 groups
Measured: Intraoperative to 2 weeks after operation.
post operative anal discharge
presence of post operative anal discharge was detected in the 2 groups
Measured: from incision to 2 weeks after operation.
pain score with visual analogue scale
pain score with visual analogue scale was studied between the 2 groups,minimum score is 0 which means painless and maximum score is 10 which means very painful
Measured: from the 1st day to 2 weeks postoperatively
Healing time
time for complete healing after operation was studied between the 2 groups
Measured: healing time was studies from the 1st day to 3 months after operation
Return to work
Return to work after operation was studied between the 2 groups
Measured: Return to work was assessed from one day to 2 months after surgery
patient satisfaction score
patient satisfaction score among patients in the 2 groups was studied using customer satisfaction score, minimum score is 1 means very dissatisfied and maximum score is 10 means very satisfied
Measured: from one day to 3 months after operation
Recurrence
recurrence between 2 groups was assessed
Measured: detection of recurrence from 3 to 6 months after operation
Fistula occurence
fistula occurence studied between the 2 groups
Measured: from 2 weeks to 2 months after operation
Stenosis
post operative stenosis between the 2 groups was studied
Measured: stenosis was detected from wound healing to 6 months later
Discharge from hospital
hospital stay studied between the 2 groups
Measured: from one day post operative to one week
Secondary outcomes (3)
age
age in the 2 groups was studied
Measured: age of participants was recorded for one year duration of the study
sex
sex was studied in the 2 groups
Measured: sex of participants was recorded for one year duration of the study
specific disease
diagnosis of crohn's disease, ulcerative colitis, non specific colitis by colonoscopy and biopsy was done in the 2 groups
Measured: diagnosis of diseases known 2 days before surgery from history
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start5 Sep 2023
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
- Investigators
- Reham Zakaria, PhD, Principal investigator, faculty of medicine Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216223
- Sponsor's protocol ID
- #101080-5-9-2023
- Status last verified
- May 2024
- First submitted
- 27 Dec 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zakaria R, Amin MM, Abo-Alella HA, Hegab YH. Laser hemorrhoidoplasty versus hemorrhoidectomy in the treatment of surgically indicated hemorrhoids in inflammatory bowel patients: a randomized comparative clinical study. Surg Endosc. 2025 Jan;39(1):249-258. doi: 10.1007/s00464-024-11351-3. Epub 2024 Nov 7.
PubMed 39511001
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Versus Laser Ablation of Anal Diseases in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT06216223
- Acronym / sponsor ID
- #101080-5-9-2023
- Conditions
- Inflammatory Bowel Diseases, Anal Fissure, Hemorrhoids
- Keywords
- anal fissure, hemorrhoids, inflammatory bowel disease, crohn's disease, ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 22 Jan 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.
This is a randomized comparative clinical trial carried out to compare between laser ablation and surgery in treating anal diseases in inflammatory bowel diseases patients and find out if one is superior to the other.
Inflammatory bowel diseases patients with anal problems were divided into 2 groups, one group had traditional surgery and the other had laser ablation for anal diseases and results were compared between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser | Active comparator | Procedure: treatment of anal diseases in inflammatory bowel patients, Device: Laserlaser ablation of anal diseases in inflammatory bowel patients |
| traditional surgery | Sham comparator | Procedure: treatment of anal diseases in inflammatory bowel patients, Procedure: traditional surgerytraditional surgery for anal diseases in inflammatory bowel patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with history of inflammatory bowel disease ( non specific colitis, crohn's disease, ulcerative colitis).
- Patients who accidently discovered to have inflammatory bowel disease.
- Age group between 18 to 60 years old
Key exclusion criteria (5 listed)
- Informed consent refusal.
- Proved malignancy in inflammatory bowel disease patients
- Patients less than 18 years old or more than 60 years old
- Contraindications to general and spinal anesthesia
- other types of colitis as ischemic colitis, pseudo-membranous colitis, infective colitis
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 |
|---|---|---|
| treatment of anal diseases in inflammatory bowel patientstreatment of anal diseases in inflammatory bowel patients | Procedure or surgery | laser, traditional surgery |
| Laserlaser | Device | laser |
| traditional surgerytraditional surgery | Procedure or surgery | traditional surgery |
Primary outcome
Operation time
Time frame: Intraoperative (from skin incision to wound dressing.)
operation time in minutes was studied between the 2 groups
operative bleeding
Time frame: Intraoperative to 2 weeks after operation.
bleeding in cc was calculated between the 2 groups
post operative anal discharge
Time frame: from incision to 2 weeks after operation.
presence of post operative anal discharge was detected in the 2 groups
pain score with visual analogue scale
Time frame: from the 1st day to 2 weeks postoperatively
pain score with visual analogue scale was studied between the 2 groups,minimum score is 0 which means painless and maximum score is 10 which means very painful
Healing time
Time frame: healing time was studies from the 1st day to 3 months after operation
time for complete healing after operation was studied between the 2 groups
Return to work
Time frame: Return to work was assessed from one day to 2 months after surgery
Return to work after operation was studied between the 2 groups
patient satisfaction score
Time frame: from one day to 3 months after operation
patient satisfaction score among patients in the 2 groups was studied using customer satisfaction score, minimum score is 1 means very dissatisfied and maximum score is 10 means very satisfied
Recurrence
Time frame: detection of recurrence from 3 to 6 months after operation
recurrence between 2 groups was assessed
Fistula occurence
Time frame: from 2 weeks to 2 months after operation
fistula occurence studied between the 2 groups
Stenosis
Time frame: stenosis was detected from wound healing to 6 months later
post operative stenosis between the 2 groups was studied
Discharge from hospital
Time frame: from one day post operative to one week
hospital stay studied between the 2 groups
3 secondary outcomes
age
Time frame: age of participants was recorded for one year duration of the study
sex
Time frame: sex of participants was recorded for one year duration of the study
specific disease
Time frame: diagnosis of diseases known 2 days before surgery from history
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 39511001Zakaria R, Amin MM, Abo-Alella HA, Hegab YH. Laser hemorrhoidoplasty versus hemorrhoidectomy in the treatment of surgically indicated hemorrhoids in inflammatory bowel patients: a randomized comparative clinical study. Surg Endosc. 2025 Jan;39(1):249-258. doi: 10.1007/s00464-024-11351-3. Epub 2024 Nov 7.
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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.
Reham Zakaria, PhD principal investigator
faculty of medicine Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment of anal diseases in inflammatory bowel patients, Laser and traditional surgery in people with Inflammatory Bowel Diseases and Anal Fissure, run by Zagazig University at 1 site in Egypt.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Operation time (time frame: Intraoperative (from skin incision to wound dressing.)). The study lists 11 primary outcomes in all. 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 NCT06216223, which also lists 1 linked publication.
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 14 May 2024.