Early oral feeding versus traditional route in patients with gastrointestinal (GI) anastomosis: a randomised controlled trial
| ISRCTN | ISRCTN32134673 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32134673 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/10/2005
- Registration date
- 18/01/2006
- Last edited
- 16/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Khosro Ayazi
Scientific
Scientific
General Surgery Department
Imam Hossein University Hospital
Shaheed Madani St
Tehran
16179
Iran
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | A period of starvation 'nil by mouth' is a common practice after GI anastomosis. The stomach is decompressed with a nasogastric tube and intravenous fluid is administrated. Then oral feeding begins after gastric dysmotility is resolved. The rational of 'nil by mouth' is to prevent postoperative nausea and vomiting, in addition to providing the anastomosis some time before being stressed by food. In another words, patients are nil per os ('NPO') to prevent early complications (nausea and vomiting) and late complications of an anastomosis such as peritonitis, abscess and sepsis due to leakages of intestinal fluids into peritoneal cavity. Contrary to the above opinion, there is evidence suggesting early feeding is beneficial. It has been shown in animals that the 'NPO' period reduces the collagen content in anastomosed tissue and diminishes the quality of healing. Whereas feeding reverses mucosal atrophy induced by starvation and increases collagen deposition and strength of the site of anastomosis. Since a great number of GI surgeries are undertaken in malnourished patients, providing them with a chance to increase their depleted collagen storage after surgery is wise. Moreover, there are clinical investigations showing that early feeding is associated with improved wound healing and reduces septic morbidity after abdominal trauma and peritonitis. Some other studies suppose that early feeding minimizes the length of hospitalization. Additionally there are studies suggesting no significant difference in any feeding routes. Most of the studies are surgical site specific. But this study takes all GI anastomosis into consideration, which might lead to a more general comment. Considering the lack of data from Iran health providers on the matter, the study may also provide some help to choose more appropriate routes for our patients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Different gastrointestinal pathologies lead to GI surgeries. |
| Intervention | Nasogastric tubes were removed immediately after surgery in both groups. In group I (early feeding) patients, oral feeding began on the first postoperative day with liquid diet and gradually changed to normal diet as tolerated. In group II (traditional route) feeding began with the same diet after resolution of ileus. That was defined by audible bowel sound plus no abdominal distension or vomiting. In the case of vomiting more than twice, the nasogastric tube was reinserted in both groups. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Decreasing the early and late complications as below: 1. Early complications (inability to tolerate oral feeding, presented with nausea and vomiting) 2. Delayed complications (due to leakage from anastomosis, such as peritonitis, abscess and sepsis, in addition to fistula and death) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2001 |
| Completion date | 01/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Being a candidate for GI anastomosis 2. Being a volunteer for participation |
| Key exclusion criteria | 1. Peritonitis 2. Albumin level <3 mg/dl 3. Age <4 years old 4. Previous history of autoimmune disease such as rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE) 5. Previous abdominal surgery 6. History of endocrine disease 7. Diabetes mellitus 8. Heart valve diseases or atherosclerosis 9. History of surgery due to abdominal trauma |
| Date of first enrolment | 01/03/2001 |
| Date of final enrolment | 01/03/2003 |
Locations
Countries of recruitment
- Iran
Study participating centre
General Surgery Department
Tehran
16179
Iran
16179
Iran
Sponsor information
Imam Hossein University Hospital (Iran)
Hospital/treatment centre
Hospital/treatment centre
Shaheed Madani St
Tehran
16179
Iran
"ROR" |
https://ror.org/04esb6v42 |
|---|
Funders
Funder type
Hospital/treatment centre
It is an internally funded project by the General Surgery Department of Imam Hossein University Hospital (Iran)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
