Cryotherapy for Post-Hemorrhoidectomy Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Milligan-Morgan Hemorrhoidectomy with Cryotherapy, Miligan-Morgan haemorroidectomy.
- Who it may be relevant to
- Registry conditions: Hemorrhoid, Hemorrhoidectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Cryotherapy on Postoperative Pain After Hemorrhoidectomy: A Randomized Controlled Trial
Overview
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.
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).
Interventions
- 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 anest - 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.
Primary outcome measures
- Pain at rest and after defecation at At day 1 postoperatively [Time frame: At day 1 postoperatively]
Secondary outcome measures (6)
- Number of participants requiring rescue analgesia within the first 24 hours postoperatively [Time frame: within the first 24 hours postoperatively]
- 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]
- Post operative urine retention [Time frame: Within 48 hours postoperatively]
- Number of participants with surgical site infection [Time frame: Up to 30 days postoperatively]
- Number of participants with Postoperative bleeding in both groups [Time frame: Up to 30 days postoperatively]
- Hospitalization period [Time frame: From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of medicine, Cairo University — Cairo
Identifiers
NCT: NCT07714122 · N-170-2026