Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
01091998
Study information
Scientific title
Acronym
Lapkon II study
Study hypothesis
Null hypothesis: The hypothesis of the randomised, controlled, multicentre study Lapkon II was that the rate of recurrence after five years is not higher after laparoscopic compared to conventional resection of colonic and upper rectal cancer.
Ethics approval(s)
Central Ethical Committee of Charité - University Medicine Berlin. Date of approval: 24/07/1998 (ref: 565/96)
Study design
Randomised, controlled, multicentre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Colonic and upper rectal cancer
Intervention
Laparoscopic vs conventional resection of colorectal carcinoma
After initial diagnostic laparoscopy, the result of the randomisation was intraoperatively revealed and the resection was carried out with either the laparoscopic or open technique.
Intervention type
Other
Primary outcome measure
Cancer-free survival 5 years after surgery
Secondary outcome measures
1. Short-term overall, general and local morbidity
2. Intraoperative complications
3. Duration of surgery
4. Length of the specimen
5. Number of lymphnodes removed
6. Status of resection margins
7. Postoperative hospital stay
Overall study start date
01/09/1998
Overall study end date
30/09/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females
2. Tumour located in the upper rectum (above 12 cm from the anal verge) or the colon
3. Scheduled for right hemicolectomy, sigmoidectomy, or anterior rectal resection
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
1,200
Participant exclusion criteria
1. Adenocarcinoma of the transverse colon or the colonic flexures necessitating extended left or right 2. Hemicolectomy or subtotal colectomy
3. Distant metastasis (i.e. liver or lung)
4. Contraindications to pneumoperitoneum
5. Acute intestinal obstruction
6. Perforation
7. Abscess
8. Malignant disease in the past 5 years (excluding skin basiloma or carcinoma in situ of the cervix)
9. Synchronous adenocarcinoma of the colorectum
10. Pregnancy
11. Age below 18 years
12. Unwilling to consent
Recruitment start date
01/09/1998
Recruitment end date
30/09/2004
Locations
Countries of recruitment
Germany
Study participating centre
General, Visceral, Vascular and Thoracic Surgery
Berlin
10117
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Germany)
Sponsor details
Charitéplatz 1
Berlin
10117
Germany
Sponsor type
University/education
Website
http://www.charite.de/en/charite/
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Participating hospitals will cover their costs for this trial. The lead hospital is Charité Campus Mitte - University Medicine Berlin (Germany)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|