Prospective, randomised, multicentre trial to assess short- and long-term results after laparoscopic and conventional resection of colorectal carcinoma

ISRCTN	ISRCTN18106465
DOI	https://doi.org/10.1186/ISRCTN18106465
Secondary identifying numbers	01091998

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

Prof Wolfgang Schwenk
Scientific

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

Study design	Randomised, controlled, multicentre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	Lapkon II study
Study objectives	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)
Health condition(s) or problem(s) studied	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
Completion date	30/09/2004

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1,200
Key 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
Key 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
Date of first enrolment	01/09/1998
Date of final enrolment	30/09/2004

General, Visceral, Vascular and Thoracic Surgery

Berlin
10117
Germany

Charité - University Medicine Berlin (Germany)
University/education

Charitéplatz 1
Berlin
10117
Germany

Website	http://www.charite.de/en/charite/
"ROR"	https://ror.org/001w7jn25

Hospital/treatment centre

Participating hospitals will cover their costs for this trial. The lead hospital is Charité Campus Mitte - University Medicine Berlin (Germany)

No information available

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