Cryotherapy for Post-Hemorrhoidectomy Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with with third or fourth degree haemorrhoids for elective Haemorrhoidectomy and their age greater than 18 years old.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Milligan-Morgan Hemorrhoidectomy with Cryotherapy
Procedure/SurgeryV-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/SurgeryV-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.
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: Miligan-Morgan haemorroidectomy with CrytherapyExperimental treatment 1 intervention
Group B: Miligan-Morgan haemorroidectomyActive comparator 1 intervention
Trial outcomes
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})
Time frame
At day 1 postoperativelySecondary outcomes
1
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
Time frame
within the first 24 hours postoperatively2
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})
Time frame
At day 2, day 7, day 14 and day 28 postoperatively3
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).
Time frame
Within 48 hours postoperatively4
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.)
Time frame
Up to 30 days postoperativelySponsors and contacts
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Source ClinicalTrials.gov
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