Cryotherapy for Post-Hemorrhoidectomy Pain

Effect of Cryotherapy on Postoperative Pain After Hemorrhoidectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhoidectomy; Hemorrhoid
• Intervention / Treatment: Procedure: Miligan-Morgan haemorroidectomy; Procedure: Milligan-Morgan Hemorrhoidectomy with Cryotherapy

Detailed Description

This prospective, patient-blinded randomized controlled trial will be conducted at the General Surgery Department, Kasr Al-Ainy Hospital, Cairo University. Adult patients (≥18 years) with grade III or IV hemorrhoids who are scheduled for elective surgery will be enrolled. Patients with concomitant anorectal pathology, inflammatory bowel disease, impaired continence, or those requiring synchronous procedures will be excluded.

Following informed consent, all patients will undergo standardized preoperative clinical assessment and routine laboratory investigations, with colonoscopy performed when clinically indicated. Participants will be randomized in a 1:1 ratio using computer-generated randomization with allocation concealment by sequentially numbered, opaque, sealed envelopes into either conventional Milligan-Morgan hemorrhoidectomy (control group) or Milligan-Morgan hemorrhoidectomy followed by intra-anal cryotherapy (cryotherapy group). In the cryotherapy group, a sterile ice pack will be inserted into the anal canal for 1 minute immediately after completion of hemorrhoidectomy.

Postoperative management will be standardized in both groups, including analgesia, local care, antibiotics, and laxatives. Postoperative Pain will be assessed using the Visual Analogue Scale (VAS).

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Mohamed Abdelaal, MD; Phone Number: 01118732767; Email: drabdelaal90@gmail.com

Study Locations

• Egypt
  • Al-Manial, Cairo, Egypt
    • Cairo, Al-Manial, Cairo, Egypt, Egypt, 11451
      • Faculty of medicine, Cairo University
      • Contact: Ahmed Mohamed Abdelaal, MD; Phone Number: +201118732767; Email: drabdelaal90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Miligan-Morgan haemorroidectomy with Crytherapy; Patients will be conducted to Miligan-Morgan haemorroidectomy with intraoperative Crytherapy	Procedure: Milligan-Morgan Hemorrhoidectomy with Cryotherapy; 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.
Active Comparator: Miligan-Morgan haemorroidectomy; Patients will be conducted to Milligan-Morgan Hemorrhoidectomy	Procedure: Miligan-Morgan haemorroidectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization period	Compare how many days patients stay in hospital in both groups	From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery
Number of participants requiring rescue analgesia within the first 24 hours postoperatively	Number of participants requiring rescue analgesia within the first 24 hours postoperatively in both groups	within the first 24 hours postoperatively
Pain during rest and after defecation at postoperative day 2,7,14 and 28	Assessment of Pain during rest and after defecation at postoperative day 2,7,14 and 28 in both 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 2, day 7, day 14 and day 28 postoperatively
Number of participants with surgical site infection	compare surgical site infection in both groups (surgical site infection: infection at or near a surgical incision within 30 days post-surgery, marked by redness, swelling, or pus.)	Up to 30 days postoperatively
Number of participants with Postoperative bleeding in both groups	Postoperative Bleeding will be assessed clinically and categorized as mild (self-limited), moderate (requiring medical treatment), or severe (requiring surgical intervention or blood transfusion).	Up to 30 days postoperatively
Post operative urine retention	compare incidence of postoperative urine retention in both groups. (Postoperative urinary retention: inability to void spontaneously after surgery with a bladder volume ≥500 mL on bladder ultrasound).	Within 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Haitham M. Azmy Basiouny, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 4, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cryotherapy; Hemorrhoidal Disease; Milligan-Morgan Hemorrhoidectomy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Hemorrhoids; Therapeutics; Cryotherapy
• Other Study ID Numbers: N-170-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because this is a small surgical trial with a limited number of participants, and sharing raw data could lead to identification of participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No