Comparison of the Clinical Effects of Open, Closed, and Semi-close Hemorrhoidectomy.

Официальное название

Comparison of the Clinical Effects of Open, Closed, and Semi-close Hemorrhoidectomy: Study Protocol for a Single-center, Prospective, Open-label and Randomized Clinical Trial.

Обзор

This study compares three different ways surgeons close the wound after removing hemorrhoids (piles): leaving it completely open, stitching it completely closed, or stitching only half of it closed (semi-closed). The goal is to see which method leads to faster healing, less pain, fewer complications, and better long-term results. Patients undergoing hemorrhoidectomy will be randomly assigned to one of the three groups. All patients will receive standard post-operative care. Researchers will measure healing time, pain levels, need for pain medication, hospital stay, complications, and check if hemorrhoids come back within one year.

Подробное описание

Hemorrhoids are a very common condition, and when surgery is needed, there is no consensus on the best way to manage the surgical wound afterward. This single-center, prospective, randomized clinical trial aims to directly compare the clinical outcomes of the three primary wound management techniques: open, closed, and semi-closed hemorrhoidectomy.

A total of 378 patients will be randomly assigned to one of the three treatment groups. The primary focus is on comparing key short-term outcomes, including the time it takes for the wound to fully heal, the length of the hospital stay, and the rate of complications such as surgical site infection, bleeding, and urinary retention.

Secondary outcomes will provide a broader picture of patient recovery. Pain will be carefully assessed using a standardized pain scale (Visual Analog Scale) on multiple days after surgery and by tracking the total amount of pain medication required during hospitalization. Furthermore, to understand the long-term effectiveness of each technique, the study will follow patients for one year after surgery to assess their quality of life and monitor for any recurrence of hemorrhoids.

This is the first clinical trial to evaluate all three techniques within the same study. The results are expected to provide high-quality evidence to help surgeons choose the most effective wound management strategy, ultimately improving patient care and recovery after hemorrhoid surgery.

Вмешательства

• Процедура Open Hemorrhoidectomy
  Patients in this group undergo a hemorrhoidectomy procedure where, after external stripping and internal ligation, the surgical wound is left entirely open without sutures to heal by secondary intention. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection.
• Процедура Closed Hemorrhoidectomy (Ferguson Technique)
  Patients in this group undergo a hemorrhoidectomy procedure where, after achieving hemostasis, the entire surgical wound is closed primarily using interrupted non-absorbable sutures. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection.
• Процедура Semi-Closed Hemorrhoidectomy
  Patients in this group undergo a hemorrhoidectomy procedure where, after achieving hemostasis, the distal half of the incision (away from the anal canal) is closed with interrupted sutures, while the proximal half remains open. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection.

Первичные конечные точки

• Wound healing time [Срок оценки: Daily from postoperative Day 1 until complete epithelialization is achieved (assessed for up to 28 days post-surgery)]

Вторичные конечные точки (4)

• Postoperative pain intensity (NRS score) [Срок оценки: Baseline (preoperative), and on postoperative days 1, 2, 3, 5, 7, and 14 (±2 days).]
• Perianal edema severity [Срок оценки: Postoperative days 1, 2, 3, 5, 7, and 14 (±2 days).]
• Length of hospital stay [Срок оценки: From end of surgery until discharge (assessed up to 7 days postoperatively).]
• Complication incidence [Срок оценки: Within 30 days after surgery.]

Критерии участия

Критерии включения

• Patients aged 18 to 75 years.
• Clinical diagnosis of mixed hemorrhoids requiring surgical intervention.
• Scheduled to undergo hemorrhoidectomy with ligation of internal hemorrhoids and excision of external hemorrhoids.
• Willing and able to provide written informed consent.

Критерии исключения

• History of mental illness or cognitive impairment that may affect the ability to provide informed consent or comply with the study protocol.
• Diagnosis of diabetes mellitus.
• Planned concomitant procedures (e.g., radiofrequency ablation, sclerotherapy) in addition to hemorrhoidectomy.
• Inability or unwillingness to comply with scheduled follow-up visits.
• Presence of severe perioperative comorbidities that render the patient unsuitable for the planned surgical protocol or anesthesia (as determined by the attending anesthesiologist or surgeon).

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07196865 · AHPutianU 2025918

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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