Transvaginal laparoscopic cholecystectomy versus standard laparoscopic cholecystectomy
| ISRCTN | ISRCTN14307590 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14307590 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/10/2008
- Registration date
- 30/12/2008
- Last edited
- 14/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Prof Klaus Gellert
Scientific
Scientific
Sana Klinikum Berlin Lichtenberg
Fanninger Str 32
Berlin
10365
Germany
Study information
| Study design | Prospective randomised controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | TV-CCE |
| Study objectives | H0: There is no reduction of pain (NRS >=1) while resting or while coughing on the day of operation, on the first postoperative or on the second postoperative day with a transvaginal assisted cholecystectomy compared to a laparoscopic cholecystectomy. H1: There is a reduction of pain (NRS>=1) while resting or while coughing on the day of operation, on the first postoperative or on the second postoperative day with a transvaginal assisted cholecystectomy compared to a laparoscopic cholecystectomy. Please note that as of 14/05/2013, the anticipated end date for this trial was updated from 01/06/2010 to 12/06/2012 |
| Ethics approval(s) | Ethics Committee of Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) approved in April 2008 (ref: EA1/035/08). |
| Health condition(s) or problem(s) studied | Cholecystolithiasis |
| Intervention | 1. Transvaginal cholecystectomy 2. Laparoscopic cholecystectomy |
| Intervention type | Other |
| Primary outcome measure | Reduction of pain, assessed with a numeric rating scale. All outcomes will be assessed on the 7th and 28th postoperative day and 1 year after surgery. |
| Secondary outcome measures | 1. Wound infections 2. Trokar herniation 3. Morbidity 4. Mortality 5. Complications 6. Fatigue 7. Costs 8. Quality of life, assessed by a tool developed by Eypasch et al (1995) and SF-36 Health Survey 9. Long-term outcome All outcomes will be assessed on the 7th and 28th postoperative day and 1 year after surgery. |
| Overall study start date | 01/06/2008 |
| Completion date | 12/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 88 |
| Key inclusion criteria | 1. Female 2. Full age (18 years or older) 3. Symptomatic cholecystolithiasis |
| Key exclusion criteria | 1. Male 2. <18 years 3. Patients desire for transvaginal/laparoscopic operation 4. Multiple adhesions 5. emergency 6. Acute cholecystitis 7. Choledocholithiasis 8. Malignoma 9. Acute vaginal infection 10. Gynaecological disease 11. Gravidity 12. Endometriosis 13. American Society of Anesthesiologists (ASA) IV 14. Liver disease (Child Pugh Criteria A, B, C) |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 12/06/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Sana Klinikum Berlin Lichtenberg
Berlin
10365
Germany
10365
Germany
Sponsor information
Sana Hospital Lichtenberg (Sana Klinikum Lichtenberg) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Fanninger Str 32
Berlin
10365
Germany
| Website | http://www.khl-berlin.de |
|---|---|
"ROR" |
https://ror.org/0071tdq26 |
Funders
Funder type
Hospital/treatment centre
Sana Hospital Lichtenberg (Sana Klinikum Lichtenberg) (Germany)
No information available
Olympus (Japan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
