A prospective randomised controlled trial of traditional hysteroscopy or "no touch" hysteroscopy comparing patient discomfort and time taken to perform each procedure
| ISRCTN | ISRCTN49078427 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49078427 |
| Protocol serial number | N0256130918 |
| Sponsor | Department of Health |
| Funder | The Royal Free Hampstead NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 13/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Adam L Magos
Scientific
Scientific
University Department of Obstetrics & Gynaecology
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine whether women who undergo traditional hysteroscopy experience more discomfort during hysteroscopy compared to women who undergo no touch hysteroscopy |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Not Applicable: Hysteroscopy |
| Intervention | Women were randomised to undergo either traditional saline hysteroscopy requiring the use of a speculum and tenaculum, or a 'no-touch' vaginoscopic hysteroscopy which does not require a speculum or tenaculum. Each group was further subdivided to have hysteroscopy with either a 2.9-mm or 4-mm hysteroscope. Patients were asked to complete pre- and postprocedure questionnaires ranking pain scores. |
| Intervention type | Other |
| Primary outcome measure(s) |
Service outcome development |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 120 |
| Key inclusion criteria | 120 patients |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 21/10/2003 |
| Date of final enrolment | 31/10/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Department of Obstetrics & Gynaecology
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2005 | Yes | No |
