Transvaginal laparoscopic cholecystectomy versus standard laparoscopic cholecystectomy

ISRCTN	ISRCTN14307590
DOI	https://doi.org/10.1186/ISRCTN14307590
Protocol serial number	N/A
Sponsor	Sana Hospital Lichtenberg (Sana Klinikum Lichtenberg) (Germany)
Funders	Sana Hospital Lichtenberg (Sana Klinikum Lichtenberg) (Germany), Olympus (Japan)

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

Sana Klinikum Berlin Lichtenberg
Fanninger Str 32
Berlin
10365
Germany

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled multicentre trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	12/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

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