Mesoglycan for Pain Control After Open Excisional HAEMOrrhoidectomy (MeHAEMO): An Observational Multicentre Study on Behalf of the Italian Society of Colorectal Surgery (SICCR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Changes in Post-operative Pain
研究概览
简要总结
Haemorrhoidal disease (HD) is the most common proctological disease, with a prevalence that can reach up to 39% of the population. Although I and II degree HD can be treated successfully with medical therapy or office-based procedures , excisional haemorrhoidectomy remains the gold standard technique in patients with III and IV degree HD, obtaining a much lower rate of recurrence than non-excisional methods, such as Doppler-guided haemorrhoidal artery ligation or stapled haemorrhoidopexy. However, both open and closed haemorrhoidectomies are associated with a significant rate of post-operative pain , which may be due to the incorporation of sensitive anal mucosa and fibres of the internal sphincters during the ligation of the vascular pedicle, post-operative scars, hygiene/social habits, hard stool, or oedema of the necessary mucocutaneous bridge.
Regarding the oedema/thrombosis of the mucocutaneous bridges, we strongly believe that it is the main cause of post-operative pain, and we have shown that the use of mesoglycan, a polysaccharide complex with antithrombotic and profibrinolytic properties, can reduce the rate of post-operative thrombosis and consequently post-operative pain 7-10 days after the procedures, improving patient quality of life and speeding up the recovery of daily activities.
Furthermore, its usefulness is also evident in the treatment of the acute phase of external haemorrhoidal thrombosis.
The aim of the study was to evaluate the efficacy of mesoglycan in the post-operative period of patients who underwent open excisional diathermy haemorrhoidectomy, confirming the previously obtained results
详细描述
This was a retrospective multicentre study and is reported according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement for cohort studies
Between September and December 2017, 206 patients with III and IV degree HD, according to Goligher classification, from sixteen colorectal referral centres belonging to SICCR (Società Italiana di Chirurgia Colorettale), who satisfied inclusion criteria underwent open excision haemorrhoidectomy.
The results obtained were compared with a homogeneous sample of 192 patients who underwent OEH in the same centres between April and July 2017 and who had received standard post-operative therapy without mesoglycan.
All patients received the standard post-operative therapy (a recommended oral dose of ketorolac tromethamine of 10 mg every 4-6 hours, not exceeding 40 mg per day and not exceeding 5 post-operative days according to the indications for short-term management of moderate/severe acute post-operative pain and stool softeners) plus mesoglycan (Prisma® 30 mg 2 vials i.m./day for the first 5 post-operative days and then Prisma® 50 mg 1 oral tablet twice/day for an additional 30 days, Mediolanum Farmaceutici, Milan, Italy).
In each referral centre, the procedures were carried out by an experienced surgeon who had performed more than 200 haemorrhoidectomies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •III and IV degree Hemorrhoidal Disease
- •Age > 18
- •Written Informed Consent
排除标准
- •Past or present history of:
- •Coagulopathy
- •Cardiac Diseases
- •Anticoagulant Therapies
- •Colorectal or Anal Neoplasms
- •Inflammatory Bowel Disease
- •Pelvic Radiotherapy
- •Anal Surgery
- •Allergy to Mesoglycan
- •Inability to return for post-operative control visits
结局指标
主要结局
Changes in Post-operative Pain
时间窗: Day 7, Day 20, Day 40
VAS
次要结局
- Changes in post-operative Bleeding(Day 7, Day 20, Day 40)
- Quality of Life (QoL)(pre- and post-operatively 90 days after the procedure)
- Changes in post-operative Thrombosis(Day 7, Day 20, Day 40)
- Changes in Surgical Wound Healing(Day 7, Day 20, Day 40)
- Changes Autonomy(Day 7, Day 20, Day 40)