Amatyakul 2001.
Methods | A prospective randomised controlled study in a single institution. Participants were randomised by using consecutively‐numbered, sealed, opaque envelopes according to the list generated from a random number table. Power calculation was performed a priori. Number of participants randomised: 106 Number of participants analysed: 106 (53 in the early group, 53 in the delayed feeding group) Analysis: Full intention‐to‐treat analysis | |
Participants | Inclusion criteria: Women scheduled for major abdominal gynaecologic surgery; mean age: 40.8 years (early group), 41.1 years (delayed feeding group) No significant difference in baseline characteristics between the two groups including age, weight, prior abdominal surgery, procedure, type of anaesthesia, operative time, estimated blood loss, and need for blood transfusion. Location: Chiang Mai University hospital, Chiang Mai, Thailand Enrolment period: September 1998 to January 1999 Exclusion criteria: Pregnancy, postoperative intensive care unit admission, endotracheal or nasogastric intubations in the immediate postoperative period, coincidental bowel surgery (excluding appendectomy), history of gastrointestinal diseases or gastrointestinal surgery (excluding appendectomy), history of pelvic or abdominal radiation, preoperative diagnosis of bowel obstruction or preoperative vomiting, preoperative bowel preparation, and history of peritonitis | |
Interventions | Early group: Participants were allowed to have sips of water within 8 hours after surgery. They were started on a soft diet in the morning of the 1st postoperative day and proceeded to a regular solid diet on the 2nd postoperative day
Delayed feeding group: Participants received nothing by mouth until at least 2 of the following signs of return of bowel function were present: 1) presence of bowel sounds; 2) passage of stool or flatus; 3) subjective hunger, in the morning of the first postoperative day. They were then allowed to have sips of water, and advanced to a liquid diet in the evening of the same day. Participants were given a soft diet in the morning of the 2nd postoperative day and were started on a regular solid diet on the 3rd postoperative day. Discharge criteria included the tolerance of a solid diet, passing flatus, and the discontinuance of intravenous fluids and medications. Participants were not required to have had a bowel movement. |
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Outcomes | Hospital stay Gastrointestinal information Morbidity (vomiting, abdominal distention) Postoperative intervals (presence of bowel sounds, passage of flatus, passage of stool, start of regular diet) |
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Notes | Funding source: self‐funded Conflicts of interest: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomised by using consecutively numbered, sealed, opaque envelopes according to the list generated from a random number table." Comment: Random number table |
Allocation concealment (selection bias) | Low risk | Quote: "Patients were randomised by using consecutively numbered, sealed, opaque envelopes according to the list generated from a random number table." Comment: Sequentially numbered, opaque, sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Because of the study's context, the participants could not be blinded. The physicians taking care of the participants were aware of their study allocation (information from the study's author). It is possible that some outcomes (hospital stay and subjective intestinal morbidities) were influenced by the lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: The outcome assessors were aware of participants' study allocation (information from the study's author). However, the influence of the lack of blinding to study outcomes was unclear. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no missing outcome data. |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not published in a protocol registry. However, the report included expected outcomes. |