Perioperative Ketotifen as treatment for postoperative ileus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25410

Enrollment

Registered

2008-02-26

Start date

2008-05-26

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative ileus Postoperatieve ileus

Interventions

Patients will be randomized to receive: 1) Ketotifen PO perioperatively (2 and 6 mg on the day before operation and 2 x 6 mg on the day of operation), and 12 mg ketotifen IP at the beginning and end

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gynaecological operation 2. 18-80 years of age 3. Median laparotomy

Exclusion criteria

Exclusion criteria: 1. Preoperative therapeutic abdominal radiation 2. Evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory test results, including abscess or cholecystitis) 3. Use of anti-allergic drugs 4. Use of laxatives, prokinetic or anti-inflammatory drugs during the first 3 postoperative days 5. American Society of Anesthesiologists physical-health status classification (ASA-PS) >3 6. Poorly regulated diabetes (>200 mg/dl (=11mmol/l)) 7. Colostomy or ileostomy, or intestinal resection as part of the surgical procedure 8. History of epileptic seizures 9. Functional constipation (Rome III criteria)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1) Colonic transit: a) Scintigraphic determination of Geometrical Centre (GC) of postprandial intra-colonic mass 48 and 72 h postoperatively b) 24 h colonic transit (i.e. delta GC between 24 h and 48 h after ingestion of 111In-DTPA labeled water) c) Ä colonic transit (before and 72 h after operation). 2) Postoperative symptoms and signs: a) time until ready for discharge b) time until first flatus in h after surgery c) time until first bowel movement in h after surgery d) reinsertion of nasogastric tube e) degree of postoperative pain, nausea, vomiting and abdominal cramping during the first 5 postoperative days	—

Measure

Time frame

1) Colonic transit: a) Scintigraphic determination of Geometrical Centre (GC) of postprandial intra-colonic mass 48 and 72 h postoperatively b) 24 h colonic transit (i.e. delta GC between 24 h and 48 h after ingestion of 111In-DTPA labeled water) c) Ä colonic transit (before and 72 h after operation). 2) Postoperative symptoms and signs: a) time until ready for discharge b) time until first flatus in h after surgery c) time until first bowel movement in h after surgery d) reinsertion of nasogastric tube e) degree of postoperative pain, nausea, vomiting and abdominal cramping during the first 5 postoperative days

—

Contacts

Public ContactSjoerd Bree, van

Meibergdreef 9

s.h.vanbree@amc.uva.020-5662061

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)