Clinical trial · Interventional
Early Alimentation Following Colorectal Surgery
Prospective, Multicentric, Randomized Phase III Study Comparing Early Oral Alimentation to Nil Per Os Diet After Colorectal Surgery
NCT00290524CI-TRIAL-00000320unknownPhase 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)
This study wants to address the question of whether or not oral alimentation should be begun early in patients following colorectal surgery compared to the classical diet which depends on reappearance of functional intestinal transit. Early oral alimentation following colorectal surgery may decrease hospitalisation stay duration.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Crohn Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral alimentation started 12 hours after colorectal surgery | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Hospitalisation stay measured in days
Secondary outcomes (3)
- measure
- Gastro-intestinal signs and symptoms
- measure
- Treatment of gastro-intestinal signs and symptoms
- measure
- Post-surgery complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient 18 years old or more * Class ASA (American Society of AnaesthesioIogy) I, II or III, +/- E * Patient willing to participate in the study * Patient who understands and accepts to sign the informed consent form * Patient who will undergo elective or urgent colic resection using laparoscopy or opened surgery defined in section B Section B: patient must meet one of the following inclusion criterion: * segmental or total colorectal resection with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy * ileal resection in continuity with total or a segment of the colon with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy * Closing of a terminal or loop colostomy Exclusion Criteria: * Class ASA IV or V patient * Documented problem of gastro-intestinal motility * Pregnancy * Any acute or recent (\<10 days) septic event * Chemotherapy during the 4 weeks preceding surgery * Previous irradiation surrounding the planned anastomosis location * Small intestine iatrogenic transparietal laceration done during surgery * Small intestine synchrone resection without continuity with the colon * Intra-peritoneal chemotherapy administered during or following surgery * Presence of residual peritoneal carcinosis at the end of surgery * Colic surgery associated with another major intra-abdominal surgery * Creation of a colo-anal or ileo-anal anastomosis * Any per-surgery discovery which requires the use of a gastric drainage procedure following surgery * Any post-surgery change in patient condition which requires naso-gastric tube holding after surgery
References
Publications (32)
- BACKGROUNDHabib AS, Gan TJ. Evidence-based management of postoperative nausea and vomiting: a review. Can J Anaesth. 2004 Apr;51(4):326-41. doi: 10.1007/BF03018236. PMID 15064261
- BACKGROUNDOlesen KL, Birch M, Bardram L, Burcharth F. Value of nasogastric tube after colorectal surgery. Acta Chir Scand. 1984;150(3):251-3. PMID 6464626
- BACKGROUNDNathan BN, Pain JA. Nasogastric suction after elective abdominal surgery: a randomised study. Ann R Coll Surg Engl. 1991 Sep;73(5):291-4. PMID 1929130
- BACKGROUNDSavassi-Rocha PR, Conceicao SA, Ferreira JT, Diniz MT, Campos IC, Fernandes VA, Garavini D, Castro LP. Evaluation of the routine use of the nasogastric tube in digestive operation by a prospective controlled study. Surg Gynecol Obstet. 1992 Apr;174(4):317-20. PMID 1553612
- BACKGROUNDPetrelli NJ, Stulc JP, Rodriguez-Bigas M, Blumenson L. Nasogastric decompression following elective colorectal surgery: a prospective randomized study. Am Surg. 1993 Oct;59(10):632-5. PMID 8214960
- BACKGROUNDPearl ML, Valea FA, Fischer M, Chalas E. A randomized controlled trial of postoperative nasogastric tube decompression in gynecologic oncology patients undergoing intra-abdominal surgery. Obstet Gynecol. 1996 Sep;88(3):399-402. doi: 10.1016/0029-7844(96)00183-4. PMID 8752247
- BACKGROUNDCheatham ML, Chapman WC, Key SP, Sawyers JL. A meta-analysis of selective versus routine nasogastric decompression after elective laparotomy. Ann Surg. 1995 May;221(5):469-76; discussion 476-8. doi: 10.1097/00000658-199505000-00004. PMID 7748028
- BACKGROUNDWolff BG, Pembeton JH, van Heerden JA, Beart RW Jr, Nivatvongs S, Devine RM, Dozois RR, Ilstrup DM. Elective colon and rectal surgery without nasogastric decompression. A prospective, randomized trial. Ann Surg. 1989 Jun;209(6):670-3; discussion 673-5. doi: 10.1097/00000658-198906000-00003.