Condition category
Surgery
Date applied
03/10/2005
Date assigned
18/01/2006
Last edited
16/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Khosro Ayazi

ORCID ID

Contact details

General Surgery Department
Imam Hossein University Hospital
Shaheed Madani St
Tehran
16179
Iran

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/2001

Overall trial end date

01/03/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Being a candidate for GI anastomosis
2. Being a volunteer for participation

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

01/03/2001

Recruitment end date

01/03/2003

Locations

Countries of recruitment

Iran

Trial participating centre

General Surgery Department
Tehran
16179
Iran

Sponsor information

Organisation

Imam Hossein University Hospital (Iran)

Sponsor details

Shaheed Madani St
Tehran
16179
Iran

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

It is an internally funded project by the General Surgery Department of Imam Hossein University Hospital (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes