Cryotherapy for Post-Hemorrhoidectomy Pain

NCT07714122 | Not Yet Recruiting

• 1 other identifier: N-170-2026
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, patient-blinded randomized controlled trial will be conducted at Kasr Al-Ainy Hospital, Cairo University. Adult patients with grade III or IV hemorrhoids undergoing elective surgery will be randomized (1:1) to either conventional hemorrhoidectomy or hemorrhoidectomy followed by intra-anal cryotherapy. All patients will undergo standardized preoperative assessment and receive the same postoperative analgesia and care. Postoperative pain will be assessed using the Visual Analogue Scale (VAS), with follow-up at postoperative day 2 and at 1, 2, 3, and 4 weeks.

Conditions

Hemorrhoid; Hemorrhoidectomy

Keywords

Hemorrhoidal Disease; Milligan-Morgan Hemorrhoidectomy; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Pain at rest and after defecation at At day 1 postoperatively

  Assessment of pain at rest and after defecation at postoperative day 1 in both treatment groups using Visual Analogue Scale (Visual Analogue Scale for Pain: ranges from 0 to 10 . Higher scores indicate a worse outcome {greater pain intensity})

  At day 1 postoperatively

Secondary Outcomes (6)

• Number of participants requiring rescue analgesia within the first 24 hours postoperatively

  within the first 24 hours postoperatively

• Pain during rest and after defecation at postoperative day 2,7,14 and 28

  At day 2, day 7, day 14 and day 28 postoperatively

• Post operative urine retention

  Within 48 hours postoperatively

• Number of participants with surgical site infection

  Up to 30 days postoperatively

• Number of participants with Postoperative bleeding in both groups

  Up to 30 days postoperatively

Study Arms (2)

Miligan-Morgan haemorroidectomy with Crytherapy

EXPERIMENTAL

Patients will be conducted to Miligan-Morgan haemorroidectomy with intraoperative Crytherapy

Procedure: Milligan-Morgan Hemorrhoidectomy with Cryotherapy

Miligan-Morgan haemorroidectomy

ACTIVE COMPARATOR

Patients will be conducted to Milligan-Morgan Hemorrhoidectomy

Procedure: Miligan-Morgan haemorroidectomy

Interventions

Miligan-Morgan haemorroidectomy PROCEDURE

V-shaped incision around the hemorrhoidal base. The hemorrhoid will be dissected in the submucosal plane to the pedicle, which will be double ligated with a 2/0 Vicryl suture before excision. The procedure will be repeated for all affected hemorrhoids while preserving adequate skin bridges to prevent anal stenosis. Hemostasis will be achieved using cautery, the wounds will be left open, and a gauze dressing will be applied.

Miligan-Morgan haemorroidectomy

Milligan-Morgan Hemorrhoidectomy with Cryotherapy PROCEDURE

V-shaped incision around the hemorrhoidal base. The hemorrhoid will be dissected in the submucosal plane to the pedicle, which will be double ligated with a 2/0 Vicryl suture before excision. The procedure will be repeated for all affected hemorrhoids while preserving adequate skin bridges to prevent anal stenosis. Hemostasis will be achieved using cautery.Then, The surgeon will insert the ice pack transanally to the proximal anal canal for 1 minute while the patient remained under general anesthesia.

Miligan-Morgan haemorroidectomy with Crytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with with third or fourth degree haemorrhoids for elective Haemorrhoidectomy and their age greater than 18 years old.

You may not qualify if:

• Concurrent anal pathology (e.g., anal fissure, fistula, )
• Patients planned for synchronous procedures
• Patients with inflammatory bowel disease
• Patients with impaired anal sphincter function or fecal incontinence

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, Al-Manial, Cairo, Egypt, 11451, Egypt

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Haitham M. Azmy Basiouny, MD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Mohamed Abdelaal, MD

CONTACT

01118732767; drabdelaal90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): August 4, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)