No registrations found.
ID
Source
Brief title
Health condition
malignant colorectal disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Total postoperative hospital stay including readmission within 30 days;
2. Quality of life measured by validated questionnaires (SF-36/Gigli) at two and four weeks after surgery;
3. Medical and non medical costs.
Secondary outcome
1. Morbidity;
2. Patient satisfaction measured by standardised questionnaires;
3. Readmission percentage.
Background summary
Background: Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of fast track recovery multimodal programs. Both programs focus on faster recovery and shorter hospital stay.
Objectives: To determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease.
Patients and
Methods: double blinded, multicenter trial with a 2 x 2 balanced factorial design. Patients eligible for segmental colectomy for malignant colorectal disease viz. right and left colectomy and anterior resection will be randomised to either open or laparoscopic colectomy, and to either standard care or the fast track program. This factorial design produces four treatment groups (a) open colectomy with standard care (b) open colectomy with fast track program (c) laparoscopic colectomy with standard care and (d) laparoscopic surgery with fast track program. Primary outcome measure are length of postoperative hospital stay including readmission within 30 days, quality of life two weeks after surgery, overall hospital costs. Secondary outcome parameters are morbidity, patient satisfaction and readmission.
Data analysis: We anticipate a difference of 4 days between standard care and the fast track laparoscopic group. Based on a mean postoperative hospital stay of 9 +/- 2.5 days a group size of 400 patients (100 each arm) can reliably detect a minimum difference of 1 day between the four arms (alfa = 0.95, beta = 0.8). With 100 patients in each arm a difference of 10% in subscales of the SF-36 and social functioning can be detected.
Study objective
That laparoscopic surgery alone or in combination with fast track perioperative care is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease.
Intervention
Laparoscopic surgery and fast track perioperative care.
P.O. Box 22660
W.A. Bemelman
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
W.A.Bemelman@amc.uva.nl
P.O. Box 22660
W.A. Bemelman
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
W.A.Bemelman@amc.uva.nl
Inclusion criteria
1. Age between 40 and 80 years;
2. Colorectal cancer including colon and rectosigmoid cancers;
3. Informed consent.
Exclusion criteria
1. Prior midline laparotomy;
2. ASA IV;
3. Laparoscopic surgeon not available;
4. Prior upper and/or lower midline laparotomy;
5. Emergency colectomy;
6. Contraindications for epidural (coagulation disorders);
7. Planned stoma.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL185 |
| NTR-old | NTR222 |
| Other | : ZonMw projectnumber: 945-06-901 |
| ISRCTN | ISRCTN79588422 |