Comparison of shea butter and lidocaine gel for rectal examination: A non-inferiority trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202011687956222

Enrollment

152

Registered

2020-11-18

Start date

2021-01-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Interventions

shea lubricant group

Lidocaine gel group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All male and female patients, conscious, 18 years and above a digital rectal examination is indicated and consents to partake in the study

Exclusion criteria

Exclusion criteria: Patients who are too ill to communicate and consent painful anal conditions (anal fissures, thrombosed hemorrhoids, infiltrating anorectal cancers) rectal stricture Patients unwilling to participate.

Design outcomes

Primary

Measure	Time frame
the primary end point is difference in pain perception before, immediately and 30 minutes after procedure, with a non-inferiority limit set at - 0.72.	—

Secondary

Measure	Time frame
differences in complication rates including discomfort, urinary urgency, bowel urgency and perianal pruritus. The convenience or otherwise associated with the use of the lubricant will also be assessed.	—

Countries

Ghana

Contacts

Public ContactDavidson Iroko

Investigator and Public relations officer

iroko.dok@gmail.com+233503838996

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026