Condition category
Cancer
Date applied
15/07/2008
Date assigned
31/07/2008
Last edited
31/07/2008
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 Wolfgang Schwenk

ORCID ID

Contact details

General
Visceral
Vascular and Thoracic Surgery
Charité - University Medicine Berlin
Campus Mitte
Charitéplatz 1
Berlin
10117
Germany

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/1998

Overall trial end date

30/09/2004

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes