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Effect of different treatment modalities in colorectal surgery on postoperative gastrointestinal motility.


- candidate number6029
- NTR NumberNTR1884
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jun-2009
- Secondary IDs05/002 METC AMC
- Public TitleEffect of different treatment modalities in colorectal surgery on postoperative gastrointestinal motility.
- Scientific TitleInfluence of laparoscopy and/or fast track multimodal management on gastrointestinal motility in comparison to open surgery and/or standard care.
- ACRONYMLAFA-motility
- hypothesisIt 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) studiedPostoperative ileus, Laparoscopy, Colorectal surgery, Open surgery, fast track care
- Inclusion criteriaThe 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 criteria1. Prior midline laparotomy;
2. ASA IV;
3. Laparoscopic surgeon not available;
4. Emergency surgery;
5. Planned stoma.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate1-okt-2009
- Target number of participants80
- Interventions4 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 outcomePostoperative gastrointestinal transit as measured by nuclear scintigraphy on POD1-3.
- Secondary outcomeSigns and symptoms of postoperative gastrointestinal motility during admission; e.g. time to first bowel movement and oral solid intake.
- TimepointsPostoperative day 1, 2,and 3 and for secondary outcomes every day untill discharge.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Sjoerd Bree, van
- CONTACT for SCIENTIFIC QUERIESDr. Sjoerd Bree, van
- Sponsor/Initiator prof. dr. G.E.E. Boeckxstaens
- Funding
(Source(s) of Monetary or Material Support)
prof. dr. G.E.E. Boeckxstaens
- PublicationsN/A
- Brief summaryRecent 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)
- RECORD26-jun-2009 - 6-okt-2009


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