Clinical trial NCT06851312: Implementation of Minimally Invasive Surgery for Grade III Hemorrhoids
Official title: Prospective Observational Study to Assess the Implementation of Minimally Invasive Surgery in the Treatment of Grade III Hemorrhoids: Phase 1 of the IDEAL Framework
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemorrhoidectomy
Minimal Invasive Surgery
Keywords: hemorrhoids grade III-IV
Hemorrhoidectomy
Minimal Invasive Surgery
IDEAl Stage 1
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the Surgery Department of our Hospital

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Technical Feasibility of Surgery
timeFrame: From enrollment to the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Palma
country: Spain
facility: Hospital Son Llatzer
Study officials:
affiliation: Hospital Son Llatzer
name: Ignacio Fernandez Hurtado, Colorectal Surgeon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.