Implementation of Minimally Invasive Surgery for Grade III Hemorrhoids

NCT06851312 — Completed, 5 participants, Hospital Son Llatzer

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Prospective Observational Study to Assess the Implementation of Minimally Invasive Surgery in the Treatment of Grade III Hemorrhoids: Phase 1 of the IDEAL Framework

Registry	NCT06851312
Status	Completed
Study type	Observational
Enrollment	5 (Actual)
Sponsor	Hospital Son Llatzer (Other)
Conditions	Hemorrhoidectomy, Minimal Invasive Surgery
Interventions	Minimal invasive hemorrhoidectomy (Procedure)
Dates	start 2025-05-01, primary completion 2025-07-01, completion 2025-08-01, first posted 2025-02-28, last updated 2026-08-13
Locations	1 site in Spain

-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. 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. In Stage 1, the first application in humans is documented, analyzing outcomes and feasibility.

Since no previous studies on the application of MIS in OEH have been found, the investigators propose a study within Stage 1 of the IDEAL model to assess the feasibility of this technique. The investigators believe its incorporation into open excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.

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+Arms and interventions

Arm	Type	Interventions	Description
Grade III Hemorrhoids		Procedure: Minimal invasive hemorrhoidectomy	Patients with symptomatic grade III hemorrhoids who consent to surgical intervention

Minimal invasive hemorrhoidectomy (Procedure): We propose applying minimally invasive surgery in open 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 OEH. Our hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery.

+Outcome measures

Primary outcomes

Technical Feasibility of Surgery [From enrollment to the surgical procedure]: Since no studies using this approach were found in the literature, the investigators propose a study to assess the feasibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 1. The measurement tool will be the number of patients in whom the technique could be performed

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

INCLUSION CRITERIA

* Age over 18 years
* Grade III hemorrhoids
* BMI below 30
* Indication for OEH 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

+Locations (1)

Facility	City	Country	Status
Hospital Son Llatzer	Palma	Spain

+Publications

Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, Rovers M, Blencowe N, Pennell C, Quinn T, Rogers W, Cook J, Kolias AG, Agha R, Dahm P, Sedrakyan A, McCulloch P. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019 Feb;269(2):211-220. doi: 10.1097/SLA.0000000000002794. PMID 29697448
McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8. PMID 19782876

+Investigators

Ignacio Fernandez Hurtado, Colorectal Surgeon, Principal investigator, Hospital Son Llatzer