Perioperative Ketotifen as treatment for postoperative ileus
- Conditions
- Postoperative ileusPostoperatieve ileus
- Registration Number
- NL-OMON25410
- Lead Sponsor
- G.E.E. BoeckxstaensMeibergdreef 91105 AZ Amsterdamthe Netherlands020-5667375g.e.boeckxstaens@amc.uva.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 58
Inclusion Criteria
1. Gynaecological operation
2. 18-80 years of age
Exclusion Criteria
1. Preoperative therapeutic abdominal radiation
2. Evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory test results, including abscess or cholecystitis)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The predefined primary endpoint of efficacy is Delta (Ä) stomach retention (before and 24 h after operation). Stomach retention is formulated as the percentage of Technetium present in the stomach 2 h after the intake of a Technetium labeled pancake.
- Secondary Outcome Measures
Name Time Method 1) Colonic transit:<br /><br>a) Scintigraphic determination of Geometrical Centre (GC) of postprandial intra-colonic mass 48 and 72 h postoperatively<br /><br>b) 24 h colonic transit (i.e. delta GC between 24 h and 48 h after ingestion of 111In-DTPA labeled water) <br /><br>c) Ä colonic transit (before and 72 h after operation).<br /><br>2) Postoperative symptoms and signs: <br /><br>a) time until ready for discharge<br /><br>b) time until first flatus in h after surgery<br /><br>c) time until first bowel movement in h after surgery <br /><br>d) reinsertion of nasogastric tube<br /><br>e) degree of postoperative pain, nausea, vomiting and abdominal cramping during the first 5 postoperative days <br>