Evaluation of Hemorrhoidectomy Techniques: Scalpel and Electrosurgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pain at rest and during defecation
研究概览
简要总结
The goal of this prospective clinical trial is to compare the outcomes of several technical options of open hemorrhoidectomy in patients with symptomatic hemorrhoids. Randomly allocated participants will undergo surgical treatment for hemorrhoids with one technical option of open hemorrhoidecomy: with 'cold' scalpel or electrosurgical instruments. All information to evaluate outcomes between the groups will be collected before surgery and 1 week and 30 days after surgery.
详细描述
This is a single-center prospective randomized controlled study will be conducted on the basis of the surgical department. Patients with symptomatic hemorrhoids and who will be intended for surgical treatment (open hemorrhoidectomy) will be randomly allocated to one of the group. Prior to surgery the demographic and clinical data will be collected. Open hemorrhoidectomy under spinal anesthesia will be performed with one of the technical options according to the patient's group:
- hemorrhoidectomy with 'cold' scalpel for cutting the perianal skin and anal mucose
- hemorrhoidectomy with electrosurgical scalpel for cutting the perianal skin and anal mucose.
Intraoperative and postoperative data will be collected during first week after surgery and 30 days after surgery. Then the primary and secondary outcomes are evaluated between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Before the operation, all patients are scheduled to perform an open hemorrhoidectomy, which includes radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Patients are not informed about which instrument will be used.
All collected information will be stored in electronic databases, where patient names and group numbers are anonymized and encrypted. Thus, during the statistical calculation, a person will not know about the name of the group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Diagnosed symptomatic hemorrhoidal disease
- •Planned surgery - open hemorrhoidectomy
- •Absence of other anarectal diseases
- •I, II class of anesthetic risk according to ASA classification
- •Voluntary signing by the participant of an informed consent for surgical treatment and participation in a clinical trial.
排除标准
- •Chronic or prolonged use of medications, including narcotic drugs, with analgesic effect for other diseases.
- •Patients who have contraindications or technical impossibility of performing subarachnoid anesthesia or the full standard volume of surgery for the corresponding disease.
- •Patients who refused to participate at any time before the end of the study, as well as patients who did not pass the final postoperative monitoring (1 month after the intervention).
- •Pregnant women
- •Complicated course of the postoperative period due to exacerbation of concomitant diseases
结局指标
主要结局
Pain at rest and during defecation
时间窗: during 10 days after surgery
The pain was assessed using a visual analogue scale (VAS uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end)
次要结局
- Readmission rate(30 days after surgery)
- Complication rate(within 30 days after surgery)
- The life quality rate(7 and 30 days)
- Rate of prescribing opioid analgesics(3 days after surgery)
- Other medications use(10 days after surgery)
- Residual symptoms(30 days after surgery)