Comparison Study of the Effect of Enema in Anal Surgery

Hemorrhoids Clinical Trial

Official title:

The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05602987
• Other study ID #: N202209016
• Status: Completed
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: October 31, 2023
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Hemorrhoids

Intervention

Procedure:
• enema
receiving enema at the night before anal surgery
• no enema
no enema before anal surgery

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang-Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	record max pain score(visual analog scale:0-10) each day	On postoperative day 0 to day 7
Primary	Consumption of analgesics	daily consumption of oral analgesics from post-operative day 0 to day 7	On postoperative day 0 to day 7
Secondary	Incidence of surgical site infection	Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.	On postoperative day 0-30
Secondary	Incidence of Urinary retention	patients requiring foley catheterization during hospital stay	On postoperative day 0 to day 7
Secondary	First defecation after surgery	Time between first defecation and operation	On postoperative day 0 to day 7