Haemorrhoidectomy With vs Without Lateral Internal Sphincterotomy

University of Baghdad

Status: Completed

Conditions: Grade III and IV Hemorrhoids

Treatments: Procedure: Hemorrhoidectomy With LIS; Procedure: Conventional Hemorrhoidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07360912

HLS-RCT-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Hemorrhoidectomy With LIS

Experimental group

Description:

Patients undergo open hemorrhoidectomy combined with lateral internal sphincterotomy to reduce postoperative pain and anal sphincter spasm.

Treatment:

Procedure: Hemorrhoidectomy With LIS

Conventional Hemorrhoidectomy

Active Comparator group

Description:

Patients undergo standard open hemorrhoidectomy without lateral internal sphincterotomy.

Treatment:

Procedure: Conventional Hemorrhoidectomy