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Comparison Study of the Effect of Enema in Anal Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05602987
Enrollment
282
Registered
2022-11-02
Start date
2022-11-14
Completion date
2023-10-31
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoids, Fistula

Brief summary

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

Detailed 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.

Interventions

PROCEDUREenema

receiving enema at the night before anal surgery

PROCEDUREno enema

no enema before anal surgery

Sponsors

Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain scoreOn postoperative day 0 to day 7record max pain score(visual analog scale:0-10) each day
Consumption of analgesicsOn postoperative day 0 to day 7daily consumption of oral analgesics from post-operative day 0 to day 7

Secondary

MeasureTime frameDescription
Incidence of surgical site infectionOn postoperative day 0-30Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.
Incidence of Urinary retentionOn postoperative day 0 to day 7patients requiring foley catheterization during hospital stay
First defecation after surgeryOn postoperative day 0 to day 7Time between first defecation and operation

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026