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OpenTrials
Completed

NCT Number: NCT07360912

Haemorrhoidectomy With vs Without Lateral Internal Sphincterotomy

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.

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Key information

Conditions

Grade III and IV Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhoids Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Rectal Diseases Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of baghdad collage of medicine

Baghdad, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemorrhoidectomy With LIS

Procedure

Open excisional hemorrhoidectomy combined with lateral internal sphincterotomy to reduce anal sphincter spasm and postoperative pain.

Conventional Hemorrhoidectomy

Procedure

Standard open excisional hemorrhoidectomy without lateral internal sphincterotomy.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Open Haemorrhoidectomy Combined With Lateral Internal Sphincterotomy Versus Conventional Haemorrhoidectomy: A Prospective Randomized Comparative Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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