Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

August 1, 2018

Primary Completion Date

July 1, 2020

Study Completion Date

July 1, 2020

Conditions
Hemorrhoids, Internal
Interventions
DRUG

Polidocanol Injectable Foam

"Two distinct periods were considered: intervention and follow-up. During the intervention period patients were observed at 3-week intervals (minimum of 3 weeks and maximum of 9 weeks depending on the number of instrumental treatments performed). The required number of sessions of any of the office-based treatments (maximum of 3 sessions) was determined by clinical and anoscopy response (if after the treatment the participant scored zero points in the Sodergren scale or the anoscopy did not reveal significant hemorrhoidal disease, there was no place for additional instrumental therapy and the patient started the follow-up period.~If there was therapeutic failure at the end of the third session or if there was a significant complication (moderate or severe) the patient's participation in the study ended and he was referred for treatment with other type of office-based procedure or surgery."

DEVICE

Rubber band ligation

"Two distinct periods were considered: intervention and follow-up. During the intervention period patients were observed at 3-week intervals (minimum of 3 weeks and maximum of 9 weeks depending on the number of instrumental treatments performed). The required number of sessions of any of the office-based treatments (maximum of 3 sessions) was determined by clinical and anoscopy response (if after the treatment the participant scored zero points in the Sodergren scale or the anoscopy did not reveal significant hemorrhoidal disease, there was no place for additional instrumental therapy and the patient started the follow-up period.~If there was therapeutic failure at the end of the third session or if there was a significant complication (moderate or severe) the patient's participation in the study ended and he was referred for treatment with other type of office-based procedure or surgery."

Trial Locations (1)

4050-000

Centro Hospitalar Universitário do Porto, Porto

All Listed Sponsors
lead

Universidade do Porto

OTHER

NCT04091763 - Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease | Biotech Hunter | Biotech Hunter