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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05602987
Other study ID # N202209016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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