A randomised controlled trial of outpatient hysteroscopy looking at the effects of temperature and pressure
| ISRCTN | ISRCTN62284430 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62284430 |
| Protocol serial number | N0256159467 |
| Sponsor | Department of Health |
| Funder | The Royal Free Hampstead NHS Trust (UK) NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 18/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Adam L Magos
Scientific
Scientific
University Department Of Obstetrics and 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 |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial of outpatient hysteroscopy looking at the effects of temperature and pressure |
| Study objectives | To determine whether women who undergo hysteroscopy experience more discomfort when there is a change in pressure and temperature of the saline used to distend the endometrial cavity |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Hysteroscopy |
| Intervention | Randomised controlled trial: 1. Normal saline, 37degree celsius, 150 mmHg 2. Normal saline, room temperature 100mmHg 3. Normal saline, room temperature, 200 mmHg 4. Saline, room temperature, 150 mmHg |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Service outcome development |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/07/2004 |
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 | 15/07/2003 |
| Date of final enrolment | 15/07/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Department Of Obstetrics and 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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/10/2017: No publications found in PubMed, verifying study status with principal investigator.
