The Necessity of Preoperative Bowel Preparation

NCT ID: NCT05053542

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 273 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-05-10

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.

Detailed 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.

Conditions

Pain, Postoperative; Analgesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Enema

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients underwent hemorrhoidectomy

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical University Shuang-Ho Hospital

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

N202009024

Identifier Type: -

Identifier Source: org_study_id