Clinical trial · Interventional
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy
A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid
NCT00467922CI-TRIAL-00002725completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out if guided fluid administration with the esophageal monitor is superior to standard fluid administration and whether use of the hetastarch or lactated ringers offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Polyps | — | UNRESOLVED | — |
| Crohn's Disease | — | UNRESOLVED | — |
| Diverticulitis | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Polyps | — | UNRESOLVED | — |
| Ulcerative Colitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hextend | Drug | — | UNRESOLVED |
| Lactated Ringers | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the relative effects of a standard, colloid or crystalloid based strategy for hand-assisted laparoscopic colectomy surgery on decreasing length of stay
- timeFrame
- 90 days
Secondary outcomes (1)
- measure
- 1. Determine the effects of the three fluid management strategies on post-operative fluid requirements in colorectal surgery. on the incidence and severity of post-operative complications. on return of gastrointestinal function.
- timeFrame
- 90 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and chronic or subacute diverticulitis 2. Subjects who will undergo hand-assisted laparoscopic colectomy for benign or malignant pathology Exclusion Criteria: 1. Patients requiring stoma formation as part of the operative procedure 2. Patients undergoing loop ileostomy or colostomy closure thru the stomal site 3. Bowel obstruction, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values) 4. Congestive heart failure, unstable angina, or valvular heart disease with New York Heart Classification \>2
References
Publications (0)
Data not yet available
No reference posted for this study.