Circumcision
Conditions
Keywords
disposable circumcision device, Tissue adhesive, Open surgical circumcision, Minimally-invasive circumcision
Brief summary
To identify a minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.
Detailed description
Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV transmission. Currently, the most widely used VMMC technique in South Africa is open surgical circumcision. According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up. This randomized controlled trial compares the open surgical technique to an alternative minimally-invasive technique using a disposable Unicirc device with tissue adhesive. The investigators postulate that VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an easier technique to learn and perform, requires less intraoperative time, is safer for both surgeons and patients, heals quicker, and is more cost effective than other currently available techniques. The disposable nature of the device is an immense advantage as it eliminates the need to sterilize and can therefore be used in resource-limited settings. It also reduces the chances of infection caused by contaminated instruments. The study will randomly assign participants to one of two groups: * Unicirc device with tissue adhesive: 100 men * Open surgical circumcision: 50 men The participants will be evaluated during follow-up visits at 2 days, 7 days, 14 days, and 28 days after surgery.
Interventions
PROCEDUREOpen surgical circumcision
Open surgical circumcision using a technique approved by the WHO (dorsal slit)
DEVICEUnicirc device with tissue adhesive
Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive.
Sponsors
Simunye Primary Health Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy men at least 18 years of age requesting circumcision * No anatomical penile abnormalities or infections * Able to provide informed consent to participate * Willing to participate in follow-up visits
Exclusion criteria
* Current illness * Penile abnormality or infection which contraindicates or would complicate circumcision * History of bleeding disorder * Past reaction to local anesthetic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Duration | 1 hour | Amount of time from first manipulation of tissue under local anesthesia to dressing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Result | Within 6 weeks after surgery | Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance) |
| Difficulty in Learning and Performing Technique | 1 year | Evaluated by doctor survey based on 5 point Likert scale 1. Unicirc is much easier 2. Unicirc is easier 3. Neutral 4. Open surgical is easier 5. Open surgical is much easier |
| Pain Experienced | Within 2 days after surgery | Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain |
| Overall Patient Satisfaction | Within 6 weeks after surgery | Patient satisfaction evaluated with questionnaire using satisfaction scale 1. Very satisfied 2. Satisfied 3. Not satisfied |
| Number of Participants With Complete Wound Healing by Post-Surgery Week 4 | Within 4 weeks after surgery | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 1 year | Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection |
Countries
South Africa
Participant flow
Recruitment details
Recruitment occurred between 31 May, 2013 and 26 June, 2013. Participants were recruited via posters at two affiliated primary care clinics in Cape Town.
Pre-assignment details
Healthy, uncircumcised men who were at least 18 years of age were eligible to participate in the study. All those who were enrolled and who showed up for their procedure were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Open Surgical Circumcision The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common. | 50 |
| Unicirc Device With Tissue Adhesive Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training. | 100 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Open Surgical Circumcision | Unicirc Device With Tissue Adhesive | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 100 Participants | 149 Participants |
| Region of Enrollment South Africa | 50 participants | 100 participants | 150 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 50 Participants | 100 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 50 | 28 / 100 |
| serious Total, serious adverse events | 0 / 50 | 0 / 100 |
Outcome results
Primary
Intraoperative Duration
Amount of time from first manipulation of tissue under local anesthesia to dressing
Time frame: 1 hour
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Open Surgical Circumcision | Intraoperative Duration | Procedure without frenulectomy (n=44,96) | 22.6 minutes | Inter-Quartile Range 8.6 |
| Open Surgical Circumcision | Intraoperative Duration | Procedure with frenulectomy (n=6,4) | 25.0 minutes | — |
| Unicirc Device With Tissue Adhesive | Intraoperative Duration | Procedure without frenulectomy (n=44,96) | 13.0 minutes | Inter-Quartile Range 4.5 |
| Unicirc Device With Tissue Adhesive | Intraoperative Duration | Procedure with frenulectomy (n=6,4) | 28.6 minutes | — |
Secondary
Cosmetic Result
Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance)
Time frame: Within 6 weeks after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Surgical Circumcision | Cosmetic Result | Regular | 20 participants |
| Open Surgical Circumcision | Cosmetic Result | Irregular | 8 participants |
| Open Surgical Circumcision | Cosmetic Result | Scalloped | 22 participants |
| Unicirc Device With Tissue Adhesive | Cosmetic Result | Regular | 79 participants |
| Unicirc Device With Tissue Adhesive | Cosmetic Result | Irregular | 12 participants |
| Unicirc Device With Tissue Adhesive | Cosmetic Result | Scalloped | 7 participants |
Secondary
Difficulty in Learning and Performing Technique
Evaluated by doctor survey based on 5 point Likert scale 1. Unicirc is much easier 2. Unicirc is easier 3. Neutral 4. Open surgical is easier 5. Open surgical is much easier
Time frame: 1 year
Population: The four physicians that participated in this study performed both procedures (i.e. open surgical and Unicirc) on study participants. Three physicians had significant previous (non-study) experience performing open surgical circumcisions. All four had no to very limited previous experience performing Unicirc circumcisions.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Open Surgical Circumcision | Difficulty in Learning and Performing Technique | 2 units on Likert scale |
Secondary
Number of Participants With Complete Wound Healing by Post-Surgery Week 4
Time frame: Within 4 weeks after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open Surgical Circumcision | Number of Participants With Complete Wound Healing by Post-Surgery Week 4 | 49 participants |
| Unicirc Device With Tissue Adhesive | Number of Participants With Complete Wound Healing by Post-Surgery Week 4 | 89 participants |
Secondary
Overall Patient Satisfaction
Patient satisfaction evaluated with questionnaire using satisfaction scale 1. Very satisfied 2. Satisfied 3. Not satisfied
Time frame: Within 6 weeks after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Surgical Circumcision | Overall Patient Satisfaction | Very satisfied | 40 participants |
| Open Surgical Circumcision | Overall Patient Satisfaction | Satisfied | 8 participants |
| Open Surgical Circumcision | Overall Patient Satisfaction | Not satisfied | 2 participants |
| Unicirc Device With Tissue Adhesive | Overall Patient Satisfaction | Very satisfied | 78 participants |
| Unicirc Device With Tissue Adhesive | Overall Patient Satisfaction | Satisfied | 15 participants |
| Unicirc Device With Tissue Adhesive | Overall Patient Satisfaction | Not satisfied | 5 participants |
Secondary
Pain Experienced
Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain
Time frame: Within 2 days after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Surgical Circumcision | Pain Experienced | Pain in first 24 hours post-op | 3.1 units on a 10-point pain scale | Standard Deviation 2.4 |
| Open Surgical Circumcision | Pain Experienced | Pain at 48 hours post-op | 1.2 units on a 10-point pain scale | Standard Deviation 2 |
| Unicirc Device With Tissue Adhesive | Pain Experienced | Pain in first 24 hours post-op | 4.2 units on a 10-point pain scale | Standard Deviation 2.7 |
| Unicirc Device With Tissue Adhesive | Pain Experienced | Pain at 48 hours post-op | 0.7 units on a 10-point pain scale | Standard Deviation 1.6 |
Other Pre-specified
Number of Participants With Adverse Events
Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Surgical Circumcision | Number of Participants With Adverse Events | Mild bleeding | 1 participants |
| Open Surgical Circumcision | Number of Participants With Adverse Events | Moderate bleeding (suturing required) | 2 participants |
| Open Surgical Circumcision | Number of Participants With Adverse Events | Hematoma | 0 participants |
| Open Surgical Circumcision | Number of Participants With Adverse Events | Infection (antibiotic required) | 6 participants |
| Unicirc Device With Tissue Adhesive | Number of Participants With Adverse Events | Infection (antibiotic required) | 10 participants |
| Unicirc Device With Tissue Adhesive | Number of Participants With Adverse Events | Mild bleeding | 4 participants |
| Unicirc Device With Tissue Adhesive | Number of Participants With Adverse Events | Hematoma | 4 participants |
| Unicirc Device With Tissue Adhesive | Number of Participants With Adverse Events | Moderate bleeding (suturing required) | 10 participants |