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NCT Number: NCT07714122

Cryotherapy for Post-Hemorrhoidectomy Pain

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.

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Key information

Conditions

Hemorrhoid Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoidectomy Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Cairo University

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

Location contact

Ahmed Mohamed Abdelaal, MD

CONTACT

[email protected]

+201118732767

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

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.

Primary outcomes

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

    Time frame: 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})

Secondary outcomes

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

    Time frame: within the first 24 hours postoperatively

    Number of participants requiring rescue analgesia within the first 24 hours postoperatively in both groups

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

    Time frame: At day 2, day 7, day 14 and day 28 postoperatively

    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})

  3. Post operative urine retention

    Time frame: Within 48 hours postoperatively

    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).

  4. Number of participants with surgical site infection

    Time frame: Up to 30 days postoperatively

    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.)

  5. Number of participants with Postoperative bleeding in both groups

    Time frame: Up to 30 days postoperatively

    Postoperative Bleeding will be assessed clinically and categorized as mild (self-limited), moderate (requiring medical treatment), or severe (requiring surgical intervention or blood transfusion).

  6. Hospitalization period

    Time frame: From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery

    Compare how many days patients stay in hospital in both groups

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed Abdelaal, MD

CONTACT

[email protected]

01118732767

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 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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