The Necessity of Preoperative Bowel Preparation

Pain, Postoperative Clinical Trial

Official title:

The Necessity of Preoperative Bowel Preparation for Hemorrhoidectomy: A Single-Center Retrospective Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053542
• Other study ID #: N202009024
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: May 10, 2021

Study information

• Verified date: August 2021
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Hemorrhoidectomy is an effective treatment for high-grade hemorrhoids and is recommended in patients with grade III-IV hemorrhoids. Common hemorrhoidectomy approaches include stapled hemorrhoidopexy and conventional procedures, such as Ferguson hemorrhoidectomy and Milligan-Morgan hemorrhoidectomy. Conventional techniques produce a lower recurrence rate, whereas stapled hemorrhoidopexy is associated with fewer postoperative complications and shorter recovery time.

Common complications after hemorrhoidectomy include urinary retention, pain, and delayed hemorrhage. Surgical site infection is a rare complication after hemorrhoid excision. Traditional opinions held that preoperative bowel preparation (PBP) reduces fecal mass and bacterial count in the bowel lumen, minimizing the risk of infective and anastomotic complications. However, a study that evaluated intramucosal bacterial count demonstrated that PBP does not reduce the colon bacterial count. A randomized control trial (RCT) evaluating the effect of PBP before colorectal surgery suggested that the procedure can be omitted. However, another RCT with 79 participants revealed that bowel preparation before anorectal surgery can result in less pain during the first postoperative defecation. A meta-analysis with 36 studies concluded that PBP before elective colorectal surgery does not affect the postoperative complication rate. On the contrary, the necessity of PBP before anorectal surgeries remains unreported. The choice of whether PBP has to be performed is often the surgeon's preference. It may be challenging for physicians to determine the appropriate decision of PBP before hemorrhoidectomy to reduce postoperative complications while minimizing patient discomfort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: May 10, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients underwent hemorrhoidectomy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative

Intervention

Procedure:
• Enema
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.

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	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
Primary	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