Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate whether oral nifedipine reduces postoperative pain and improves wound healing after hemorrhoidectomy in adult patients aged 18-65 years undergoing elective surgery for grade III or IV hemorrhoids in Sana'a, Yemen.
The main questions it aims to answer are:
Researchers will compare the nifedipine group to the placebo group to see if there is a significant reduction in pain scores, faster wound healing, lower analgesic consumption, and fewer complications.
Participants will:
Hemorrhoidal disease affects approximately 4.4% of the global population and is one of the most common anorectal conditions. Post-hemorrhoidectomy pain remains the most significant complaint and barrier to recovery, often exceeding patient expectations and delaying return to daily activities. The pathophysiology involves tissue trauma, inflammation, and internal anal sphincter spasm, which creates a cycle of pain and impaired healing. Calcium channel blockers such as nifedipine reduce smooth muscle tone and improve local microcirculation, suggesting benefit in this context. While topical calcium channel blockers have been studied, oral nifedipine offers advantages in compliance, predictable systemic delivery, and suitability for resource-limited settings such as Yemen. This trial addresses a specific gap in evidence for oral nifedipine after hemorrhoidectomy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine 20 mg oral capsules | Experimental | Oral nifedipine 20 mg capsule twice daily (every 12 hours) for 14 consecutive days. First dose administered 6 hours after surgery. |
|
| Placebo oral capsules | Placebo Comparator | Identical-appearing placebo capsule (same color, size, taste, and packaging) twice daily for 14 days, starting 6 hours after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine 20 Mg | Drug | Nifedipine 20 mg immediate-release oral capsule, twice daily for 14 days. First dose 6 hours after surgery. L-type calcium channel blocker causing internal anal sphincter smooth-muscle relaxation, reduced resting pressure, improved local blood flow, and potential anti-inflammatory/analgesic effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score | Pain intensity measured on a 0-10 Visual Analogue Scale. Higher scores indicate worse pain. Assessed at rest and with defecation. | Day 1, Day 2, Day 3, Day 7, Day 14, Day 28 |
| Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) Score | Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) score. Range 0-15; lower scores indicate better healing. | Day 7, Day 14, Day 28 |
| Time to Complete Wound Healing | Number of days from surgery until complete epithelialization of all surgical wounds confirmed by clinical examination. | Up to Day 28 (censored if not healed by Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Analgesic Consumption | Total number of paracetamol and diclofenac doses consumed during the 14-day study period. | Day 0 through Day 14 |
| Postoperative Complications | Incidence of bleeding, infection, urinary retention, and anal stenosis. Binary (yes/no) for each. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kholood Ahmed AL-Subari, M.B.B.Ch | Contact | +967772729669 | drkholooda@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Yasser Abdurabo Obadiel, Associate Professor | Faculty of Medicine and Health Sciences, Sana'a University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Jumhouri Teaching Hospital | Sanaa | Yemen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25389477 | Background | Golfam F, Golfam P, Golfam B, Pahlevani P. Comparison of topical nifedipine with oral nifedipine for treatment of anal fissure: a randomized controlled trial. Iran Red Crescent Med J. 2014 Aug;16(8):e13592. doi: 10.5812/ircmj.13592. Epub 2014 Aug 5. | |
| 36357803 | Background | Jin J, Unasa H, Bahl P, Mauiliu-Wallis M, Svirskis D, Hill A. Can Targeting Sphincter Spasm Reduce Post-Haemorrhoidectomy Pain? A Systematic Review and Meta-Analysis. World J Surg. 2023 Feb;47(2):520-533. doi: 10.1007/s00268-022-06807-3. Epub 2022 Nov 10. |
Not provided
Not provided
The study team does not plan to share individual participant data with other researchers. This is a single-center thesis study with limited data management infrastructure, and the dataset contains identifiable clinical information that cannot be sufficiently de-identified for broad sharing under local ethical guidelines.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Parallel assignment with 1:1 allocation. Participants randomized to either oral nifedipine 20 mg twice daily or identical placebo for 14 days post-hemorrhoidectomy. No crossover. Block randomization (block size 4, variable) with sequentially numbered opaque sealed envelopes (SNOSE) for allocation concealment.
Not provided
Not provided
In addition to the four checked roles, the independent statistician performing data analysis and the independent pharmacist preparing study capsules are also masked to treatment allocation.
|
| Placebo | Drug | Inert placebo capsule matched to nifedipine in color, size, taste, and packaging. Administered twice daily for 14 days, starting 6 hours after surgery. |
|
| Day 7, Day 14, Day 28 |
| Return to Normal Daily Activities | Number of days until patient reports return to normal daily activities (self-reported). | Day 28 |
| Return to Work | Number of days until return to employment or usual occupational duties (self-reported). | Day 28 |
| Patient Satisfaction | Overall satisfaction with pain management and recovery, measured on a Likert scale or binary satisfied/dissatisfied. | Day 28 |
| Adverse Events - Cardiovascular | Incidence of hypotension (systolic blood pressure [SBP] < 90 mmHg), dizziness, flushing, headache, tachycardia. | Throughout 14-day treatment and Day 28 |
| Adverse Events - General | Incidence of any serious or non-serious adverse event, including allergic reactions, gastrointestinal symptoms. | Throughout 14-day treatment and Day 28 |
| 20100408 | Background | Perrotti P, Dominici P, Grossi E, Cerutti R, Antropoli C. Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre, prospective, randomized, double-blind study. Can J Surg. 2010 Feb;53(1):17-24. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |