Cryotherapy for Post-Hemorrhoidectomy Pain

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Процедура 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 anest
• Процедура 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.

Первичные конечные точки

• Pain at rest and after defecation at At day 1 postoperatively [Срок оценки: At day 1 postoperatively]

Вторичные конечные точки (6)

• Number of participants requiring rescue analgesia within the first 24 hours postoperatively [Срок оценки: within the first 24 hours postoperatively]
• Pain during rest and after defecation at postoperative day 2,7,14 and 28 [Срок оценки: At day 2, day 7, day 14 and day 28 postoperatively]
• Post operative urine retention [Срок оценки: Within 48 hours postoperatively]
• Number of participants with surgical site infection [Срок оценки: Up to 30 days postoperatively]
• Number of participants with Postoperative bleeding in both groups [Срок оценки: Up to 30 days postoperatively]
• Hospitalization period [Срок оценки: From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of medicine, Cairo University — Cairo

Идентификаторы

NCT: NCT07714122 · N-170-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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