NCT07142382

Brief Summary

Perianal abscess is a purulent infection of the tissues surrounding the anal canal and rectum. The postoperative wound is prone to infection, and the literature indicates that hip bathing is helpful to prevent infection, reduce edema, and promote healing. Therefore, patients need to use a bidet for medical sitz bath to avoid infection and contamination. The bidet on the market is divided into ordinary type and rinse type (manual or electric). There are no high-quality studies comparing the effects of these sitz baths. A prospective randomized controlled trial was designed to investigate the effects of regular sitz bath, manual irrigation, and electric irrigation. A total of 102 patients with perianal abscess in the Affiliated Hospital of Putian University were included in the study. The patients were 18-75 years old and underwent surgical treatment. Patients with recurrent abscess, anal fistula, mental disease, pregnant or lactating women, and diabetes were excluded. The patients were divided into general group, manual group and electric group by random number table method, with 34 cases in each group. All patients received hip bathing with 0.02% potassium permanganate solution at 41-43 ° C three times a day for 10-15 minutes each time after surgery.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

August 13, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

August 13, 2025

Last Update Submit

September 13, 2025

Conditions

Keywords

sitz bathperianal absecessWound healing

Outcome Measures

Primary Outcomes (1)

  • Wound healing time

    The effectiveness of different sitbath methods in promoting recovery after perianal abscess was demonstrated by the healing time of the patient's surgical wound.

    Daily from Day 1 until complete epithelialization (max 60 days post-op)

Secondary Outcomes (2)

  • Complication incidence

    Time Frame: Within 30 days postoperatively

  • pain and swelling

    Day 1, 3, 5, 7, and Day 14±2

Study Arms (3)

conventional group

NO INTERVENTION

Patients in the conventional group were advised to use a regular bidet without a flusher after surgery. The patient was treated with potassium permanganate sitz bath from the first postoperative day. The concentration of potassium permanganate solution used in the sitz bath was 0.02%. The patient had a sitz bath three times a day (9:00, 13:00, and 17:00) and the perianal area was scrubbed through a cotton cloth. Each sitz bath lasts 10-15 minutes and the water temperature is 41-43 ° C.

Manual group

EXPERIMENTAL

Patients in the manual group were advised to use a manual flushing bidet with an irrigator after surgery. The patient was treated with potassium permanganate sitz bath from the first postoperative day. The concentration of potassium permanganate solution used in the sitz bath was 0.02%. The patients were advised to have a sitz bath three times a day (9:00, 13:00, 17:00). By manually pressing the airbag, the potassium permanganate solution in the bidet was sprayed with the rinsing device to achieve the purpose of cleaning the perianal area. The duration of each sitz bath was 10-15 minutes, and the water temperature was 41-43 ° C.

Behavioral: Ordinary sitz bath, manual flushing sitz bath, electric flushing sitz bath

electric group

EXPERIMENTAL

Patients in the electric group were advised to use an electric flushing bidet with an irrigator after surgery. The patient was treated with potassium permanganate sitz bath from the first postoperative day. The concentration of potassium permanganate solution used in the sitz bath was 0.02%. The patients were advised to take a sitz bath three times a day (9:00, 13:00, 17:00), and spray potassium permanganate solution in the bidet through an electric douche to achieve the purpose of cleaning the perianal area. The duration of each sitz bath was 10-15 minutes, and the water temperature was 41-43 ° C.

Behavioral: Ordinary sitz bath, manual flushing sitz bath, electric flushing sitz bath

Interventions

Ordinary sitz bath, manual flushing sitz bath, electric flushing sitz bath

Manual groupelectric group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 18 and 75 years
  • Patients were diagnosed with perianal abscess
  • Underwent perianal abscess treatment
  • Underwent sitz bath after surgery

You may not qualify if:

  • Patients with recurrent perianal abscesses or those with concurrent formation of anal fistulas;
  • Patients with Crohn's disease;
  • Patients with mental disorders;
  • Pregnant or lactating women;
  • Patients with diabetes;
  • Patients with a history of malignant tumor treatment within the past 5 years. ; -Patients who are using immunosuppressants or steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Putian University Affiliated Hospital

Putian, China

Location

Central Study Contacts

Meifen MF Chen, Bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 26, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

August 14, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations