|- candidate number||6029|
|- NTR Number||NTR1884|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-jun-2009|
|- Secondary IDs||05/002 METC AMC|
|- Public Title||Effect of different treatment modalities in colorectal surgery on postoperative gastrointestinal motility.|
|- Scientific Title||Influence of laparoscopy and/or fast track multimodal management on gastrointestinal motility in comparison to open surgery and/or standard care.|
|- hypothesis||It can be hypothesized that fast track care and/or laparoscopy are associated with less exaggerated inflammatory response during and after surgery resulting in faster recovery of postoperative gastrointestinal motility.|
|- Healt Condition(s) or Problem(s) studied||Postoperative ileus, Laparoscopy, Colorectal surgery, Open surgery, fast track care|
|- Inclusion criteria||The study population consists of patients eligible for segmental colectomy for malignant colorectal disease viz.
right and left colectomy and anterior resection.
Inclusion criteria are:|
1. Age between 40 and 80 years;
2. Colorectal cancer including colon and recto sigmoid cancers;
3. ASA I-III.
|- Exclusion criteria||1. Prior midline laparotomy;|
2. ASA IV;
3. Laparoscopic surgeon not available;
4. Emergency surgery;
5. Planned stoma.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2005|
|- planned closingdate||1-okt-2009|
|- Target number of participants||80|
|- Interventions||4 different treatment arms for patients eligible for segmental colectomy for malignant colorectal disease:|
1. Laparoscopic surgery + fast track care*;
2. Laparoscopic surgery + standard care;
3. Open surgery + fast track care*;
4. Open surgery + standard care.
*Multimodal fast track perioperative recovery program which focusses on shorter hospital stay and faster recovery.
|- Primary outcome||Postoperative gastrointestinal transit as measured by nuclear scintigraphy on POD1-3. |
|- Secondary outcome||Signs and symptoms of postoperative gastrointestinal motility during admission; e.g. time to first bowel movement and oral solid intake.
|- Timepoints||Postoperative day 1, 2,and 3 and for secondary outcomes every day untill discharge.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Sjoerd Bree, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Sjoerd Bree, van|
|- Sponsor/Initiator ||prof. dr. G.E.E. Boeckxstaens|
(Source(s) of Monetary or Material Support)
|prof. dr. G.E.E. Boeckxstaens|
|- Brief summary||Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay. Time untill recovery of gastrointestinal motility is the major determinant of length of hospital stay.
The randomized controlled LAFA-site study (LAparoscopy and/or FAst track multimodal management versus standard care) was conceived to determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care with regard to postoperative gastrointestinal motility.
Patients eligible for segmental colectomy for malignant colorectal disease will be randomized to either:|
1. Open colectomy with fast track;
2. Laparoscopic colectomy with standard care;
3. Laparoscopic surgery with fast track.
Primary outcome parameter is postoperative gastrointestinal transit. Secondary outcome parameters are signs and symptoms of postoperative gastrointestinal motility.
|- Main changes (audit trail)|
|- RECORD||26-jun-2009 - 6-okt-2009|