NCT01909765

Brief Summary

To compare the effect of two different surgical techniques, the dorsal slit and double incision technique, on postoperative pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

July 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

July 29, 2013

Status Verified

July 1, 2013

Enrollment Period

1 month

First QC Date

July 18, 2013

Last Update Submit

July 26, 2013

Conditions

Postoperative Pain

Keywords

Circumcisionpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • To asses postoperative pain scores on Modified Objective Assessment Scale (MOAS)

    Postoperative first two hours

Study Arms (2)

Dorsal slite

ACTIVE COMPARATOR

Skin and mucosa insicion made together

Other: Dorsal slit

Double incision

EXPERIMENTAL

Skin and mucosa incision made separately

Other: Double incision

Interventions

Dorsal slitOTHER

Skin and mucosa incision made together

Dorsal slite
Double incisionOTHER

Skin and mucosa incision made separately

Also known as: Surgical technique
Double incision

Eligibility Criteria

Age2 Years - 14 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children

You may not qualify if:

  • Patients with any bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Education and Research Hospital

Ankara, 06610, Turkey (Türkiye)

Location

Related Publications (1)

  • Karakoyunlu N, Polat R, Aydin GB, Ergil J, Akkaya T, Ersoy H. Effect of two surgical circumcision procedures on postoperative pain: A prospective, randomized, double-blind study. J Pediatr Urol. 2015 Jun;11(3):124.e1-5. doi: 10.1016/j.jpurol.2015.01.002. Epub 2015 Mar 3.

    PMID: 25842991DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Wound Closure Techniques

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Reyhan Polat, MD

    Yildirim Beyazit Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 29, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

July 29, 2013

Record last verified: 2013-07

Locations

TU(1)