The objective of this trial is to compare time to gastrointestinal recovery after elective colorectal surgery between patients treated with a laxative versus patients treated with a placebo.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to gastrointestinal recovery, defined as time to first flatus and first
defecation.
Secondary outcome
Appreciation of the laxatives being used, overall hospital stay and incidence
of postoperative complications (anastomotic leakage, wound infection,
intra-abdominal abscess
Background summary
Postoperative ileus is a well-known consequence of abdominal surgery which
leads to prolonged hospital stay. Over the past years, the implementation of
ERAS programs have lead to a reduction in postoperative hospital stay. The use
of laxatives after colorectal surgery within these protocols is not yet
evidence based.
Study objective
The objective of this trial is to compare time to gastrointestinal recovery
after elective colorectal surgery between patients treated with a laxative
versus patients treated with a placebo.
Study design
A single center prospective randomized placebo controlled trial.
Intervention
The laxatives being used in this trial are magnesiumoxide and bisacodyl.
Patients will receive the laxative or the placebo for three days
postoperatively, twice daily starting on the evening of surgery.
Study burden and risks
Participation is not associated with risks.
Henri Dunantstraat 5
6419 PC
Nederland
Henri Dunantstraat 5
6419 PC
Nederland
Listed location countries
Age
Inclusion criteria
Patients planned for elective colorectal surgery will be included regardless of age, underlying pathology or co-morbidity. Procedures to be performed include right hemicolectomy, transversectomy, left hemicolectomy, sigmoid resection, low anterior resection, polypectomy, abdominoperineal resection, reconstruction ileostomy, reconstruction colostomy, laparoscopic right or left hemicolectomy
Exclusion criteria
Lacking informed consent, age <18 years, objection by treating physician, emergency procedures, contra-indications to the laxatives being used or the use of other types of laxatives than magnesiumoxide or bisacodyl.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-012700-53-NL |
| CCMO | NL28256.096.09 |
| OMON | NL-OMON26932 |