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.
ID
Bron
Verkorte titel
Aandoening
-postoperative ileus
-postoperative motility/transit
-colorectal surgery
-laparoscopic surgery
-open surgery
-standard care
-fast track care
In Dutch:
-postoperatieve ileus
-postoperatieve gastrointestinale motiliteit/transit
-maag darm motoriek
-colorectale chirurgie
-laparoscopische chirurgie
-open chirurgie
-traditioneel herstel programma
-fast track herstel programma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Postoperative gastrointestinal transit as measured by nuclear scintigraphy on POD1-3.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Postoperative day 1, 2,and 3 and for secondary outcomes every day untill discharge.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Prior midline laparotomy;
2. ASA IV;
3. Laparoscopic surgeon not available;
4. Emergency surgery;
5. Planned stoma.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1774 |
NTR-old | NTR1884 |
Ander register | METC AMC : 05/002 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |