Haemorrhoidectomy With vs Without Lateral Internal Sphincterotomy

January 13, 2026 updated by: Alaa Alsalaumy, University of Baghdad

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq
        • University of baghdad collage of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemorrhoidectomy With LIS
Patients undergo open hemorrhoidectomy combined with lateral internal sphincterotomy to reduce postoperative pain and anal sphincter spasm.
Procedure: Hemorrhoidectomy With LIS
Open excisional hemorrhoidectomy combined with lateral internal sphincterotomy to reduce anal sphincter spasm and postoperative pain.
Active Comparator: Conventional Hemorrhoidectomy
Patients undergo standard open hemorrhoidectomy without lateral internal sphincterotomy.
Procedure: Conventional Hemorrhoidectomy
Standard open excisional hemorrhoidectomy without lateral internal sphincterotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Postoperative day 1, day 2, day 7, and day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative bleeding
Time Frame: Postoperative day 1, day 2, day 7, and day 14
Postoperative bleeding was recorded as the presence or absence of bleeding from the surgical site after hemorrhoidectomy.
Postoperative day 1, day 2, day 7, and day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Investigators

  • Principal Investigator: Alaa Alsalaumy, Master degree, University of baghdad, college of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLS-RCT-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the dataset contains confidential clinical information and there is no public data repository for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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