NCT07874711

Brief Summary

There is still much to discover in the field of proctological postoperative care. There has already been some, albeit very little, research about its use post-haemorrhoidectomy as well as its possible effect on anal fissures, but no articles to date have been written about the use of bidets in the treatment of anal fistula or after surgery for fissures. This lack of research is evident in the guidelines written about proctological problems. The guidelines about wound rinsing after proctological surgery are based on expert opinion instead of on research and they don't mention the use of bidets at all.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
25mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Dec 2028

Study Start

First participant enrolled

October 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 15, 2026

Status Verified

September 1, 2026

Enrollment Period

2.2 years

First QC Date

October 5, 2026

Last Update Submit

October 9, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • mean difference between the 2 groups in comfort of the anal rinsing

    mean difference between the 2 groups in comfort of the anal rinsing using a 5-level Likert scale and the patient-reported pruritus on a 10-VAS-score

    From signing the ICF till 6 weeks after

  • mean difference between the 2 groups in ease of use

    The difference between the two groups in terms of ease of use of the bidet compared with conventional rinsing will be assessed using a self-developed questionnaire.

    From signing the ICF till 6 weeks after

  • mean difference between the 2 groups in perceived hygiene

    The difference between the two groups in terms of perceived hygiene of the bidet compared with conventional rinsing will be assessed using a self-developed questionnaire.

    From signing the ICF till 6 weeks after

Secondary Outcomes (2)

  • mean change in overall patient satisfaction

    time of singing the ICF till 6 weeks after

  • perceived quality of personal care

    time of singing the ICF till 6 weeks after

Study Arms (2)

standard water rinsing

PLACEBO COMPARATOR
Other: standard water rinsing

Electronic bidet

ACTIVE COMPARATOR
Device: Electronic bidet

Interventions

an electronic bidet will be used to rinse the postoperative anal wounds

Electronic bidet

standard water rinsing will be used to clean postoperative anal wounds

standard water rinsing

Eligibility Criteria

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

You may qualify if:

  • Patients will undergo fistulotomy or sphincter-sparing surgery for AF or haemorrhoidec-tomy for HD
  • years or older
  • Able to speak and read Dutch or French
  • Patients must have a power outlet within 3m of their toilet or they need to be able to use an extension cable

You may not qualify if:

  • Systemic diseases with perianal impact
  • Altered perianal sensation (to prevent burns because of the warm water)
  • Inflammatory bowel disease
  • Chronic dermatological conditions
  • AIDS
  • Hepatitis C
  • Patients under immunosuppression after a solid organ or stem cell transplantation
  • Heart failure
  • Kidney failure with eGFR under 60ml/min
  • Current malignancy
  • Pregnancy or breastfeeding
  • The use of a bidet at home before the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 40 patients that undergo surgery for haemorrhoidal disease or anal fistula will be divided into 2 groups. The first group will need to carry out the standard water rinsing with a showerhead to keep the postoperative anal wound clean. The second group will need to use an electronic bidet to clean their postoperative anal wound.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 15, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

October 15, 2026

Record last verified: 2026-09

Locations