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 |
| Protocol serial number | 01091998 |
| Sponsor | Charité - University Medicine Berlin (Germany) |
| Funder | Participating hospitals will cover their costs for this trial. The lead hospital is Charité Campus Mitte - University Medicine Berlin (Germany) |
- Submission date
- 15/07/2008
- Registration date
- 31/07/2008
- Last edited
- 31/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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 Wolfgang Schwenk
Scientific
Scientific
General, Visceral, Vascular and Thoracic Surgery
Charité - University Medicine Berlin
Campus Mitte
Charitéplatz 1
Berlin
10117
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, multicentre study |
| Secondary study design | Randomised controlled trial |
| 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(s) | Cancer-free survival 5 years after surgery |
| Key secondary outcome measure(s) | 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 |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1200 |
| 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
General, Visceral, Vascular and Thoracic Surgery
Berlin
10117
Germany
10117
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 |
