Condition category
Digestive System
Date applied
10/10/2008
Date assigned
30/12/2008
Last edited
14/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Klaus Gellert

ORCID ID

Contact details

Sana Klinikum Berlin Lichtenberg
Fanninger Str 32
Berlin
10365
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TV-CCE

Study hypothesis

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

Ethics Committee of Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) approved in April 2008 (ref: EA1/035/08).

Study design

Prospective randomised controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cholecystolithiasis

Intervention

1. Transvaginal cholecystectomy
2. Laparoscopic cholecystectomy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/06/2008

Overall trial end date

12/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Full age (18 years or older)
3. Symptomatic cholecystolithiasis

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

88

Participant 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)

Recruitment start date

01/06/2008

Recruitment end date

12/06/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Sana Klinikum Berlin Lichtenberg
Berlin
10365
Germany

Sponsor information

Organisation

Sana Hospital Lichtenberg (Sana Klinikum Lichtenberg) (Germany)

Sponsor details

Fanninger Str 32
Berlin
10365
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.khl-berlin.de

Funders

Funder type

Hospital/treatment centre

Funder name

Sana Hospital Lichtenberg (Sana Klinikum Lichtenberg) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Olympus (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes