Clinical Research Directory

Reproducibility of Minimally Invasive Surgery for Grade III Hemorrhoids

Hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. Their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. In advanced cases (Goligher Grade III-IV), surgery is the only effective treatment. Open excisional hemorrhoidectomy (OEH), based on the Milligan-Morgan technique, is the standard procedure. Although effective in the long term, it causes severe postoperative pain. Minimally invasive surgery (MIS) employs enhanced visualization devices to improve surgical precision and reduce tissue damage. While widely used in specialties with small surgical fields, it has not yet been explored in anal surgery. Its advantages include reduced tissue injury and improved healing, although it presents a learning curve and an initially longer surgical time. The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. The IDEAL phase 2a is aimed at the optimization and technical definition of surgical innovation with a focus on continuous improvement based on real clinical practice, laying the foundation for broader and more rigorous subsequent studies. Since no previous studies on the application of MIS in OEH have been found, the investigators propose a study within Stage 2A of the IDEAL model to assess the reproducibility of this technique. The investigators believe its incorporation into open excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.

Acupuncture for Post-hemorrhoidectomy Pain Control

The goal of this clinical trial is to learn if acupuncture improves pain control after hemorrhoidectomy in patients with symptomatic hemorrhoids. It will also learn about the safety of using acupuncture in surgical patients. The main questions it aims to answer are: Does acupuncture lower the maximal pain intensity after hemorrhoidectomy? Does acupuncture reduce analgesics requirement, length of hospital stay and quality of recovery? Researchers will compare fully active acupuncture to a sham treatment (a look-alike procedure with minimum acupuncture stimulation) to see if active acupuncture works to improve pain control. Participants will: Receive acupuncture treatment for 7 times over first 5 days after surgery. Visit the clinic once 2 weeks after surgery for checkups and tests. Keep a diary of their symptoms and the number of times they take pain-killers.

The Impact of Methylene Blue on the Quality of Recovery in Patients Undergoing Hemorrhoidectomy

Classical hemorrhoidectomy is known to be linked with significant postoperative pain, which can result in patient discomfort, extended hospital stays, and increased costs. The Quality of Recovery (QOR) score serves as an objective measure of patient-centered general health status following surgery and anesthesia. The latest version, QOR-15, is known for its time-efficiency, high rate of response, and completion, and has been validated in patients undergoing a range of surgical procedures. Methylene blue (MB) is a water-soluble thiazine dye used to treat various conditions and has been found to have a unique analgesic property through the temporary disruption of anal sensory nerve terminals in patients. Studies conducted in Singapore and China have shown that perianal intradermal injection of MB provides temporary pain relief after hemorrhoidectomy and lateral anal sphincterotomy. However, there is limited published information regarding the impact of MB on the quality of recovery in anorectal surgery. This study aims to evaluate the effect of intradermal MB combined with ropivacaine injection on the quality of recovery for patients undergoing hemorrhoidectomy. Study population Patients with symptomatic third- and fourth-degree hemorrhoids who are undergoing hemorrhoidectomy under spinal anesthesia and are admitted to the hospitals (145 for each group) will be prospectively enrolled in this study. Before participating, all patients or their caregivers will provide written informed consent. The protocol for this study has been approved by the Ethical Committee of Qilu Hospital of Shandong University with the protocol number Kyll-202405-041-2. Intervention A standardized spinal anesthesia technique will be utilized, and between 7-9 mg of ropivacaine (Shijiazhuang Siyao Co., Ltd, 10ml:100mg) will be intrathecally injected between the L3 through L5 intervertebral spaces. All patients will undergo hemorrhoidectomy by colorectal surgeons with senior professional titles according to standard techniques. The postoperative analgesia regimen, with or without MB (Jichuan Pharmaceutical Group Co., LTD., 2ml: 20mg), will be determined at the discretion of the colorectal surgeon. Data collection Clinical data, including age, sex, acute complications and total hospitalization cost, will be collected from the enrolled patients. The QOR-15 score will be calculated for all patients. Over a 6-month follow-up period, complications and the Wexner score for postoperative fecal incontinence will be recorded through telephone interviews. Outcome measures The primary goal of this study is to evaluate the quality of recovery using the QOR-15 questionnaire, a comprehensive measure of recovery after surgery that assesses five dimensions: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11-point scale based on its frequency on the questionnaire (higher scores indicate greater frequency for positive items and less frequency for negative items). The total score ranges from 0 (poorest recovery quality) to 150 (best recovery quality). Patients will complete the QOR-15 questionnaire at three time points: the day before surgery, postoperative day 1, and postoperative day 2 (between 4 pm and 6 pm). The postoperative day 1 score is the primary outcome of interest. Additional assessments included the following: The study will collect data on the Visual Analogue Score of pain at multiple time points (postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 7, postoperative day 14), total hospitalization costs, dosage of analgesics three days and fourteen days after surgery, pain leading to unscheduled hospital returns or stay, and various complications such as urinary retention, fecal incontinence, itch and perianal paresthesia, secondary bleeding, perianal infection, poor wound healing at different postoperative time points (postoperative day 1, postoperative day, 1 month postoperative, 3 months postoperative, 6 months postoperative). Additionally, the Wexner score for postoperative fecal incontinence will be recorded at 1 month and 3 months postoperative.

Postoperative Pain in the Surgical Treatment of Hemorrhoids: Conventional Hemorrhoidectomy With a Monopolar Electric Scaler VS Bipolar Energy With Caiman® (Aesculap®)

To demonstrate that postoperative pain secondary to Milligan and Morgan hemorrhoidectomy with Caiman® (AESCULAP®) and subsequent oral conventional analgesia is at least not greater than that generated after hemorrhoidectomy with monopolar diathermy and intravenous analgesia with care home at discharge.