Implementation of Minimally Invasive Surgery for Grade III Hemorrhoids

NCT ID: NCT06851312

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-08-01

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.

Conditions

Hemorrhoidectomy; Minimal Invasive Surgery

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Grade III Hemorrhoids

Patients with symptomatic grade III hemorrhoids who consent to surgical intervention

Minimal invasive hemorrhoidectomy

Intervention Type: 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.

Interventions

Minimal invasive hemorrhoidectomy

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Son Llatzer

OTHER

Sponsor Role: lead

Responsible Party

Ignacio Fernandez Hurtado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ignacio Fernandez Hurtado, Colorectal Surgeon

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Llatzer

Locations

Hospital Son Llatzer

Palma, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 29697448 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19782876 (View on PubMed)

Other Identifiers

HEM IDEAL1

Identifier Type: -

Identifier Source: org_study_id