The Necessity of Preoperative Bowel Preparation

NCT05053542 | Completed

• 1 other identifier: N202009024
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

Hemorrhoidectomy is an common treatment for high-grade hemorrhoids. The necessity of preoperative bowel preparation (PBP) in hemorrhoidectomy is inconclusive. This study aims to evaluate the benefit and safety of PBP in hemorrhoidectomy.

Conditions

Pain, Postoperative; Analgesia

Outcome Measures

Primary Outcomes (2)

• Post-operative pain and

  A numerical rating scale (NRS) was used for measuring daily postoperative pain, where 0 represented no pain and 10 represented the worst pain ever experienced.

  4 weeks

• Post-operative oral analgesic use.

  The daily dose of oral analgesics was recorded to represent patients' dependence on medicine for postoperative pain control.

  4 weeks

Study Arms (1)

With or without enema before operation

Patients who had received pre-operative bowel preparation(PBP) were identified using electronic medical records. Patients prescribed an enema solution (EVAC enema 118 mL/bot, Purzer Pharmaceutical Co., Ltd) before surgery were allocated to the PBP group. Patients who received no PBP were allocated to none PBP group.

Procedure: Enema

Interventions

Enema PROCEDURE

Patients in the PBP group underwent a cleansing enema procedure with a solution of monosodium phosphate and disodium phosphate (EVAC enema 118 mL/bot, Purzer Pharmaceutical Co., Ltd) before hemorrhoidectomy, whereas patients in the non-PBP group skipped the procedure.

With or without enema before operation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient underwent hemorrhoidectomy in Taipei Medical University Shuang-Ho Hospital.

You may qualify if:

• Patients underwent hemorrhoidectomy

You may not qualify if:

• Patients who had received emergent or other anorectal surgery, such as fistulectomy, were excluded.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang-Ho Hospital

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Enema

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 22, 2021
• Study Start: March 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: May 10, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-08

Locations

TW (1)