Comparison Study of the Effect of Enema in Anal Surgery

Taipei Medical University

Status: Completed

Conditions: Fistula; Hemorrhoids

Treatments: Procedure: enema; Procedure: no enema

Study type: Interventional

Funder types: Other

Identifiers

NCT05602987

N202209016

Details and patient eligibility

About

To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.

Full description

For patients undergoing anal surgery, some of them receive enema as doctors' preference before the surgery in consider to lower postoperative complications e.g. infection, while others do not. These choices are often determined by surgeons' personal preference according to their experiences due to lack of evidence from researches. Hemorrhoidectomy and fistulotomy are the most common two types of surgery in colon and rectal surgery division in Shuang Ho hospital, where top three quantities of hemorrhoidectomy in Taiwn have been performed.Therefore, we conducted a randomized controlled trial to evaluate the benefits of enema before anal surgery and possible waste of medical resources.

Enrollment: 282 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy
• Patients who underwent fistulotomy or fistulectomy

Exclusion criteria

• Emergency surgery
• Surgery other than circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy, e.g., rubber band ligation, injection treatment, and cryosurgery
• Complicated fistulectomy, e.g., requiring surgical drainage and seton placement
• Other types of anal surgery, e.g., anal fissure and colorectal cancer
• Liver cirrhosis
• Coagulation dysfunction
• Bedridden
• Human immunodeficiency virus infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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282 participants in 2 patient groups

Study Group: enema

Experimental group

Description:

receiving enema at the night before anal surgery

Treatment:

Procedure: enema

Control Group: no enema

Active Comparator group

Description:

no enema before anal surgery

Treatment:

Procedure: no enema