Grade III and IV HemorrhoidsNCT07360912
Haemorrhoidectomy With vs Without Lateral Internal Sphincterotomy
A study testing Hemorrhoidectomy With LIS and Conventional Hemorrhoidectomy in people with Grade III and IV Hemorrhoids, run by University of Baghdad at 1 site in Iraq.
Trial summary
Hemorrhoids are a common anorectal condition that often require surgical treatment in advanced stages. Open hemorrhoidectomy is effective but is frequently associated with significant postoperative pain and early bleeding. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Grade III and IV Hemorrhoids
- What is being tested?
- Hemorrhoidectomy With LIS and Conventional Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- 1 Mar 2024to 30 Jul 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 70 years
- Patients diagnosed with grade III or IV hemorrhoids
- Patients scheduled for open hemorrhoidectomy
- Patients able to provide informed consent
Who cannot join
- Patients with inflammatory bowel disease
- Patients with anal fissure, fistula, or anorectal malignancy
- Patients with previous anorectal surgery
- Patients with bleeding or coagulation disorders
- Patients unfit for surgery or general or spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Haemorrhoidectomy Combined With Lateral Internal Sphincterotomy Versus Conventional Haemorrhoidectomy: A Prospective Randomized Comparative Study
Hemorrhoids are a common anorectal condition that often require surgical treatment in advanced stages. Open hemorrhoidectomy is effective but is frequently associated with significant postoperative pain and early bleeding. Increased anal sphincter spasm after surgery is believed to be a major contributor to these complications.
This study evaluates whether adding lateral internal sphincterotomy (LIS) to conventional open hemorrhoidectomy reduces postoperative pain and bleeding. A total of 120 adult patients with Grade III or IV hemorrhoids were randomized to undergo either open hemorrhoidectomy with LIS or open hemorrhoidectomy alone. Postoperative pain was assessed using a visual analogue scale, and postoperative bleeding was recorded at 24 hours, 48 hours, one week, and two weeks after surgery.
The results of this trial aim to determine whether the addition of LIS provides better short-term recovery and improved postoperative outcomes compared with standard hemorrhoidectomy.
Read the detailed description
This was a prospective, randomized, comparative clinical trial conducted at Baghdad Teaching Hospital, Iraq, between March 2024 and July 2025. Adult patients aged 18 to 70 years with symptomatic Grade III or IV hemorrhoids were eligible for inclusion. Patients with other anorectal diseases, previous anorectal surgery, inflammatory bowel disease, malignancy, or significant comorbidities were excluded.
A total of 120 patients were randomly assigned into two groups using sealed opaque envelopes. Group A underwent open hemorrhoidectomy combined with lateral internal sphincterotomy, while Group B underwent open hemorrhoidectomy alone. All procedures were performed under general anesthesia by the same experienced surgeon to maintain procedural consistency.
Postoperative pain was assessed using a visual analogue scale at 24 hours, 48 hours, one week, and two weeks after surgery. Postoperative bleeding was recorded at the same time points. Standard postoperative care, including analgesia and sitz baths, was provided to all patients.
The primary outcome was the proportion of patients who were pain-free at one week after surgery. Secondary outcomes included postoperative bleeding at all follow-up time points. The study aimed to evaluate whether the addition of lateral internal sphincterotomy improves early postoperative recovery compared with conventional hemorrhoidectomy alone.
- Conditions
- Grade III and IV Hemorrhoids
- Being tested
- Hemorrhoidectomy With LIS, Conventional Hemorrhoidectomy
- Keywords
- Hemorrhoids, Hemorrhoidectomy, Lateral Internal Sphincterotomy, Postoperative Pain, Postoperative Bleeding
- Medical subject headings
- Lymphoma, Follicular, Hemorrhoids, Pain, Postoperative, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemorrhoidectomy With LISProcedure or surgery
Open excisional hemorrhoidectomy combined with lateral internal sphincterotomy to reduce anal sphincter spasm and postoperative pain.
Conventional HemorrhoidectomyProcedure or surgery
Standard open excisional hemorrhoidectomy without lateral internal sphincterotomy.
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhoidectomy With LIS | Experimental | Patients undergo open hemorrhoidectomy combined with lateral internal sphincterotomy to reduce postoperative pain and anal sphincter spasm. Receives: Procedure: Hemorrhoidectomy With LIS |
| Conventional Hemorrhoidectomy | Active comparator | Patients undergo standard open hemorrhoidectomy without lateral internal sphincterotomy. Receives: Procedure: Conventional Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Pain intensity after hemorrhoidectomy measured using a Visual Analog Scale (VAS, 0-10).
Measured: Postoperative day 1, day 2, day 7, and day 14
Secondary outcomes (1)
Postoperative bleeding
Postoperative bleeding was recorded as the presence or absence of bleeding from the surgical site after hemorrhoidectomy.
Measured: Postoperative day 1, day 2, day 7, and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Mar 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
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 Grade III and IV HemorrhoidsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Alsalaumy, University of Baghdad
- Investigators
- Alaa Alsalaumy, Master degree, Principal investigator, University of baghdad, college of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360912
- Sponsor's protocol ID
- HLS-RCT-2024
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains confidential clinical information and there is no public data repository for this study.
Publications
Alsalaumy AHA. Open haemorrhoidectomy combined with lateral internal sphincterotomy versus conventional haemorrhoidectomy: a prospective randomized comparative study. BMC Surg. 2026 Apr 17;26(1):362. doi: 10.1186/s12893-026-03714-5.
PubMed 41992176
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Haemorrhoidectomy Combined With Lateral Internal Sphincterotomy Versus Conventional Haemorrhoidectomy: A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07360912
- Acronym / sponsor ID
- HLS-RCT-2024
- Conditions
- Grade III and IV Hemorrhoids
- Keywords
- Hemorrhoids, Hemorrhoidectomy, Lateral Internal Sphincterotomy, Postoperative Pain, Postoperative Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 22 Jan 2026 (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.
Hemorrhoids are a common anorectal condition that often require surgical treatment in advanced stages. Open hemorrhoidectomy is effective but is frequently associated with significant postoperative pain and early bleeding. Increased anal sphincter spasm after surgery is believed to be a major contributor to these complications.
This study evaluates whether adding lateral internal sphincterotomy (LIS) to conventional open hemorrhoidectomy reduces postoperative pain and bleeding. A total of 120 adult patients with Grade III or IV hemorrhoids were randomized to undergo either open hemorrhoidectomy with LIS or open hemorrhoidectomy alone. Postoperative pain was assessed using a visual analogue scale, and postoperative bleeding was recorded at 24 hours, 48 hours, one week, and two weeks after surgery.
The results of this trial aim to determine whether the addition of LIS provides better short-term recovery and improved postoperative outcomes compared with standard hemorrhoidectomy.
Detailed description
This was a prospective, randomized, comparative clinical trial conducted at Baghdad Teaching Hospital, Iraq, between March 2024 and July 2025. Adult patients aged 18 to 70 years with symptomatic Grade III or IV hemorrhoids were eligible for inclusion. Patients with other anorectal diseases, previous anorectal surgery, inflammatory bowel disease, malignancy, or significant comorbidities were excluded.
A total of 120 patients were randomly assigned into two groups using sealed opaque envelopes. Group A underwent open hemorrhoidectomy combined with lateral internal sphincterotomy, while Group B underwent open hemorrhoidectomy alone. All procedures were performed under general anesthesia by the same experienced surgeon to maintain procedural consistency.
Postoperative pain was assessed using a visual analogue scale at 24 hours, 48 hours, one week, and two weeks after surgery. Postoperative bleeding was recorded at the same time points. Standard postoperative care, including analgesia and sitz baths, was provided to all patients.
The primary outcome was the proportion of patients who were pain-free at one week after surgery. Secondary outcomes included postoperative bleeding at all follow-up time points. The study aimed to evaluate whether the addition of lateral internal sphincterotomy improves early postoperative recovery compared with conventional hemorrhoidectomy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemorrhoidectomy With LIS | Experimental | Procedure: Hemorrhoidectomy With LISPatients undergo open hemorrhoidectomy combined with lateral internal sphincterotomy to reduce postoperative pain and anal sphincter spasm. |
| Conventional Hemorrhoidectomy | Active comparator | Procedure: Conventional HemorrhoidectomyPatients undergo standard open hemorrhoidectomy without lateral internal sphincterotomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 70 years
Key exclusion criteria (5 listed)
- Patients with inflammatory bowel disease
- Patients with anal fissure, fistula, or anorectal malignancy
- Patients with previous anorectal surgery
- Patients with bleeding or coagulation disorders
- Patients unfit for surgery or general or spinal anesthesia
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 |
|---|---|---|
| Hemorrhoidectomy With LISOpen excisional hemorrhoidectomy combined with lateral internal sphincterotomy to reduce anal sphincter spasm and postoperative pain. | Procedure or surgery | Hemorrhoidectomy With LIS |
| Conventional HemorrhoidectomyStandard open excisional hemorrhoidectomy without lateral internal sphincterotomy. | Procedure or surgery | Conventional Hemorrhoidectomy |
Primary outcome
Postoperative Pain
Time frame: Postoperative day 1, day 2, day 7, and day 14
Pain intensity after hemorrhoidectomy measured using a Visual Analog Scale (VAS, 0-10).
1 secondary outcome
Postoperative bleeding
Time frame: Postoperative day 1, day 2, day 7, and day 14
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 22 Jan 2026.
- Derived from this study: PubMed 41992176Alsalaumy AHA. Open haemorrhoidectomy combined with lateral internal sphincterotomy versus conventional haemorrhoidectomy: a prospective randomized comparative study. BMC Surg. 2026 Apr 17;26(1):362. doi: 10.1186/s12893-026-03714-5.
- ClinicalTrials.gov study recordLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains confidential clinical information and there is no public data repository for this study.
Related trials for Grade III and IV Hemorrhoids
Active, not recruiting
Argon Plasma Coagulation in Open Excisional Hemorrhoidectomy
Hemorrhoidal Disease, Hemorrhoid Pain
Not yet recruiting
Low Excision and High Suspension Hemorrhoidectomy Versus Conventional Milligan-Morgan Hemorrhoidectomy for Grade III-IV Mixed Hemorrhoids
Mixed Hemorrhoids
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.
Alaa Alsalaumy, Master degree principal investigator
University of baghdad, college of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemorrhoidectomy With LIS and Conventional Hemorrhoidectomy in people with Grade III and IV Hemorrhoids, run by University of Baghdad at 1 site in Iraq.
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 4 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 22 Jan 2026. 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 Iraq. 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?
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?
Postoperative Pain (time frame: Postoperative day 1, day 2, day 7, and day 14). 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 NCT07360912, 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 22 Jan 2026.