Randomized controlled trial to investigate the need for tamponde dressing after haemorrhoidectomy.

Not Applicable

• Conditions: K64.2; Third degree haemorrhoids

• Registration Number: DRKS00011590
• Lead Sponsor: St. Elisabeth Klinik

Brief Summary

Out of 950 patients screened, 754 were randomized and 725 received intervention (366 patients in the intervention and 359 patients in the control group). In the group with tamponade dressings, median pain intensity on the 0 to 10 scale was 6 (interquartile range (i.q.r.) 4-7). Patients without tamponade dressings reported significantly less pain (median 5 (i.q.r. 3-7), P < 0.001). In each group, five patients (1.4 per cent) experienced severe bleeding. The absolute difference for the severe bleeding rate was -0.03 per cent with the 90 per cent confidence interval ranging from -1.47 per cent to +1.41 per cent, in line with the non-inferiority aim. No significant between-group difference was found for secondary outcomes

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-12
• Study Completion: 2020-12-31
• Results First Posted: 2022-05-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 754

Inclusion Criteria

1. Haemorhhoides grad 3 and 4 with terminated surgical procedure.
2.greater than or equal 18 years
3.legal capacity
4.written consent form

Exclusion Criteria

1. pregnancy
2. non-compliance with the study process
3.Participation in other trials
4. Persons who have a dependent relationship to the investigator
5. Inflammatory diseases (anal) such as abscesses, fistula or gangrene

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Max. postoperative pain (elevated by NRS) within 48h after surgery<br>2. Post-operative bleeding of surgical revesion within 7 days after ectomy

Secondary Outcome Measures

Name	Time	Method
1. Measurement of pain at the time points 6, 12, 24, 48h,and on Visit 3 and 4.<br>2. Appllication of analgesics<br>3. lowest Haemoglobin value within 7 days<br>4. Query of Quality of life on Visit 1,3 and 4 (EQ5D questionnaire)<br>5. Query of patient satisfaction on Visit 4 (patient satisfaction questionnaire)