Effect of Pre-operative Carbohydrate Loading on Return of Bowel Function After Reversal of Ileostomy

NCT07684755 | Completed DMC

• 1 other identifier: IHHN_IRB_2025_06_017
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

An ileostomy is a common surgery in which part of the small intestine is brought to the surface of the abdomen to allow waste to leave the body. When it is no longer needed, another operation is performed to reconnect the intestine (ileostomy reversal). Although ileostomy reversal is usually a straightforward procedure, some patients experience a temporary slowing or stopping of bowel function after surgery, called post-operative ileus. This can affect up to 3 out of every 10 patients. Symptoms may include nausea, vomiting, bloating, difficulty eating, and not passing gas or stool. Post-operative ileus occurs because surgery, anesthesia, inflammation, and fluid shifts can temporarily affect how the intestines work. When bowel function takes longer than expected to return, patients may need to stay in the hospital longer and may experience additional stress and discomfort. Enhanced Recovery After Surgery (ERAS) programs are designed to help patients recover more quickly after surgery. One important part of these programs is pre-operative carbohydrate loading, where patients drink a carbohydrate-rich beverage before surgery. Research suggests that this may improve the body's response to surgery, reduce nausea and vomiting, and help bowel function return sooner. At Indus Hospital Karachi, ileostomy reversals are commonly performed, particularly in young and middle-aged patients. Finding ways to reduce post-operative ileus could shorten hospital stays, help patients return to their normal activities sooner, and reduce pressure on healthcare resources.

Conditions

Ileostomy

Keywords

Carbohydrate loading; Ileostomy Reversal; Preoperative

Outcome Measures

Primary Outcomes (2)

• Episodes of nausea, vomiting

  Patients will be assessed post-operatively, for the presence of nausea or vomiting on the 1st, 2nd, 3rd day and 4rth day of surgery. The outcome will be measured by the resident in the ward and via questionnaire

  Post operative day 1st, 2nd, 3rd, 4rth day

• Interval of hours between end of surgery and passing of flatus, audible gut sounds, tolerance to semi-solid food

  Interval of hours between end of surgery and passage of flatus, audible gut sounds, tolerance to semi-solid food will be measured at 12, 24, 36, 48 and 72 hours after surgery. Passage of flatus will documented after asking the patient. Gut sounds will auscultated with the help of Pittman 3 stethoscope by the resident on ward duty. Tolerance to semi solid food will be assessed on the 3rd to 4rth post operative day once the primary surgeon has allowed to do so. All of the data will be entered in a questionnaire to assess the outcome measure.

  12, 24, 36, 48, 72 hours

Study Arms (2)

Experimental

EXPERIMENTAL

Participants receiving carbohydrate drink pre- operatively

Dietary Supplement: Carbohydrate drink

Coontrol

PLACEBO COMPARATOR

Participants receiving lemon drink as placebo pre-operatively

Other: Placebo

Interventions

Carbohydrate drink DIETARY_SUPPLEMENT

Pre-operative carbohydrate drink will be given to participants in experimental/ interventional arm

Experimental

Placebo OTHER

Control group receiving placebo

Coontrol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• ASA class 2 and below

You may not qualify if:

• · Evidence of chronic/active intestinal disease
• Post-operative complication/morbidity besides postoperative ileus
• Failure of conservative management at more than 72 hours

Sponsors & Collaborators

• Indus Hospital and Health Network: lead

Study Sites (1)

Indus Hospital and Health Network

Karachi, Sindh, 45500, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate trainee

Model Details: Patients will be randomly assigned to either the test or control group using a computer-based or envelope method. Those in the test group will receive 200 ml of a carbohydrate-rich drink, while patients in the control group will be given 200 ml of a sugar-free lemon-flavored beverage. To minimize identification, the drinks will be served by staff using opaque jugs on the evening before surgery. An additional 200 ml of the respective drink will be administered by nursing staff at 06:00 on the morning of surgery, ensuring a minimum preoperative fasting period of two hours. Post-operatively, the interval (in hours) will be noted between the end of surgery and passing of flatus. Patient will be examined for audible gut sounds at 12, 24,36,48,60 and 72 hours post operatively by a 3rd year General surgery (and above) with the help of Littmans stethoscope. Patient will also be assessed for nausea and vomiting at the said hours. He/she will also have their serum electrolytes checked on a daily

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: July 6, 2026
• Study Start: November 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 15, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

PA (1)