Hemorrhoid, Hemorrhoidectomy
Conditions
Keywords
Hemorrhoidal Disease, Milligan-Morgan Hemorrhoidectomy, Cryotherapy
Brief summary
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
PROCEDUREMilligan-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.
PROCEDUREMiligan-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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at rest and after defecation at At day 1 postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants requiring rescue analgesia within the first 24 hours postoperatively | within the first 24 hours postoperatively | Number of participants requiring rescue analgesia within the first 24 hours postoperatively in both groups |
| Pain during rest and after defecation at postoperative day 2,7,14 and 28 | 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}) |
| Post operative urine retention | 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). |
| Number of participants with surgical site infection | 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.) |
| Number of participants with Postoperative bleeding in both groups | 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). |
| Hospitalization period | 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 |
Countries
Egypt
Contacts
CONTACTAhmed Mohamed Abdelaal, MD
STUDY_DIRECTORHaitham M. Azmy Basiouny, MD
Cairo University
Outcome results
None listed