Hemorrhoidectomy, Minimal Invasive Surgery
Conditions
Keywords
hemorrhoids grade III-IV, Minimal Invasive Surgery, IDEAL stage 1, Closed hemorrhoidectomy
Brief summary
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. Excisional hemorrhoidectomy is the standard procedure. There are two main options: without wound closure (Milligan-Morgan technique) and with wound closure (Ferguson technique). Both options are effective in the long term and cause severe postoperative pain, although comparative studies between Milligan-Morgan and Ferguson hemorrhoidectomy have shown that the Ferguson technique is associated with less postoperative pain and better early wound healing, while maintaining similar long-term efficacy. 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 scarcely been explored in anal surgery. Its potential advantages include reduced tissue injury and improved healing, although it entails a learning curve and may initially prolong operative time. The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. IDEAL phase 2a focuses on the optimization and technical definition of a surgical innovation, emphasizing continuous improvement based on real clinical practice and laying the foundation for broader and more rigorous subsequent studies. Since no previous studies on the application of MIS in closed Ferguson hemorrhoidectomy have been identified, the investigators propose a phase 2a IDEAL study to assess the reproducibility of this minimally invasive adaptation. The investigators hypothesize that incorporating MIS into the Ferguson technique could further reduce postoperative pain and accelerate recovery, while preserving the well-established effectiveness of closed hemorrhoidectomy in advanced hemorrhoidal disease.
Interventions
PROCEDUREMinimal invasive closed hemorrhoidectomy
We propose applying minimally invasive surgery to closed Ferguson excisional hemorrhoidectomy, the most effective technique for treating advanced hemorrhoidal disease. We believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of excisional hemorrhoidectomy. Our hypothesis is based on reduced tissue trauma, the increased precision provided by minimally invasive surgery, and secure tissue closure.
Sponsors
Hospital Son Llatzer
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years * Grade III-IV hemorrhoids * Indication for excisional hemorrhoidectomy surgery * Signed written informed consent
Exclusion criteria
* Acute hemorrhoidal disease (thrombosis) * Previous hemorrhoid surgery * Coexistence of anal fissure * Coexistence of perianal fistula * Coexistence of rectal or anal prolapse * Active inflammatory bowel disease * Active anal or colorectal cancer * Language barrier or difficulty in oral and/or written comprehension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Reproducibility of Surgery | 30 postoperative days | Since no studies using this approach were found in the literature, the investigators propose a study to assess the reproducibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 2A. The measurement tool will be the systematic documentation of technical modifications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events in treated patients | 30 postoperative days | Collect the adverse effects that occur during the operative period and within the first 30 postoperative days. Filter those attributable to the use of the minimally invasive approach. Analyze the causes and the technical steps that should be performed or omitted to avoid them. As measurement tools, the Clavien-Dindo scale and the Comprehensive Complication Index (CCI) will be used. The CCI is an index that uses the Clavien-Dindo scale and is calculated with a mathematical formula available at www.assessurgery.com |
| Total number of postoperative analgesics | 14 postoperative days | The total number of analgesic doses taken by the patient during the first 14 postoperative days will be recorded as a numeric variable |
| Postoperative pain | The first 14 postoperative days | Postoperative pain will be evaluated using the Visual Analogue Scale (VAS), a validated tool ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will self-assess their baseline pain and pain following defecation at predefined intervals: postoperative days 4, 7, and 14. |
| Short Health Scale in hemorrhoidal disease | One year postoperative | A subjective scale which defines symptom intensity, the patient's worrying and the role in impairment of daily activity. Score 4 to 28. Higher scores mean a worse outcome. |
| Hemorrhoidal disease symptom score | one postoperative year | A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome. |
| Hemorrhoidal Clinical Fail Rate | One postoperative year | It is a pragmatic composite endpoint. It is determined by assessing changes in haemorrhoidal symptoms according to the HDSS and haemorrhoidal disease-related quality of life according to the SHS-HD, comparing baseline and 1-year values. The change in haemorrhoidal symptoms is calculated using the following formula: (baseline HDSS-postoperative HDSS)/baseline HDSS×100. The change in haemorrhoidal disease-related quality of life is calculated using the following formula: (baseline SHS-HD-postoperative SHS-HD)/baseline SHS-HD×100. CFR is positive when both criteria show a reduction of at least 50%. |
Countries
Spain
Contacts
CONTACTIgnacio Fernandez_Hurtado, MD
PRINCIPAL_INVESTIGATORIgnacio Fernandez-Hurtado, MD
Hospital Son Llatzer
Outcome results
None listed