NCT07808281

Brief Summary

Postoperative bowel motility is an important indicator of recovery after abdominal surgery and may be influenced by preoperative nutritional status. Adherence to the Mediterranean diet has been associated with favorable gastrointestinal function because of its high content of dietary fiber, unsaturated fatty acids, polyphenols, and other bioactive compounds. This prospective observational cohort study aims to investigate the association between preoperative adherence to the Mediterranean diet and postoperative bowel motility in adults undergoing elective abdominal surgery. A total of 110 participants will be assessed for Mediterranean diet adherence using the Mediterranean Diet Adherence Screener (MEDAS). Nutritional status, dietary intake, and perioperative characteristics will be recorded. Postoperative bowel motility outcomes, including time to first bowel sound, first flatus, first defecation, oral intake, and hospital discharge, will be prospectively monitored. The findings are expected to improve understanding of the relationship between preoperative dietary patterns and postoperative gastrointestinal recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

August 2, 2026

Last Update Submit

September 7, 2026

Conditions

Keywords

Mediterranean dietMEDASAbdominal surgeryGastrointestinal motility

Outcome Measures

Primary Outcomes (1)

  • Time to first bowel sound

    Time in hours from completion of surgery, defined as the record time of exit from the operating room, to the first documented bowel sound. Bowel sounds were assessed hourly by surgical residents and recorded on a standardised monitoring form.

    From completion of surgery until the first documented bowel sound, assessed during the postoperative hospital stay (up to 48 hours postoperatively).

Secondary Outcomes (4)

  • Time to first flatus

    From completion of surgery until the first patient-reported passage of flatus, assessed during the postoperative hospital stay (up to 48 hours postoperatively).

  • Time to first defecation

    From completion of surgery until the first patient-reported postoperative defecation, assessed during the postoperative hospital stay (up to 48 hours postoperatively).

  • Time to first oral fluid intake

    From completion of surgery until the first documented oral fluid intake, assessed during the postoperative hospital stay (up to 48 hours postoperatively).

  • Postoperative Length of Hospital Stay

    From completion of surgery until hospital discharge, assessed up to 60 days postoperatively.

Study Arms (1)

Adults Undergoing Elective Laparoscopic Cholecystectomy

Adults undergoing elective laparoscopic cholecystectomy who were enrolled in this prospective observational cohort study. Preoperative nutritional status and adherence to the Mediterranean diet were assessed before surgery. Participants were not assigned to exposure groups; subgroup analyses according to Mediterranean Diet Adherence Screener (MEDAS) scores were performed during statistical analysis. Postoperative bowel motility outcomes were prospectively recorded for all participants.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adults undergoing elective laparoscopic cholecystectomy at the General Surgery Clinic of İnönü University Faculty of Medicine Hospital. Participants were enrolled prospectively between February and April 2026. Preoperative nutritional status and adherence to the Mediterranean diet were assessed before surgery, and postoperative bowel motility outcomes were prospectively monitored during hospitalization.

You may qualify if:

  • Adults aged 18 years or older and younger than 70 years.
  • Scheduled to undergo elective laparoscopic cholecystectomy.
  • Able to provide written informed consent.
  • Able to complete the preoperative Food Frequency Questionnaire (FFQ) and 3-day dietary record.
  • Able to complete all study assessments and postoperative follow-up.

You may not qualify if:

  • Cesarean section (obstetric surgery).
  • Emergency abdominal surgery.
  • Structural bowel obstruction following bowel resection or presence of a temporary ileostomy or colostomy.
  • Active inflammatory bowel disease (Crohn's disease or ulcerative colitis) during the preoperative period.
  • Impaired consciousness or inability to provide informed consent.
  • Pregnancy.
  • Previous bowel surgery within the last 3 months.
  • Short bowel syndrome or conditions requiring chronic parenteral nutrition.
  • Severe systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bahcesehir University

Istanbul, Turkey (Türkiye)

Location

İnönü University Faculty of Medicine Hospital

Malatya, Turkey (Türkiye)

Location

Related Publications (4)

  • Tosti V, Bertozzi B, Fontana L. Health Benefits of the Mediterranean Diet: Metabolic and Molecular Mechanisms. J Gerontol A Biol Sci Med Sci. 2018 Mar 2;73(3):318-326. doi: 10.1093/gerona/glx227.

    PMID: 29244059BACKGROUND
  • Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14.

    PMID: 22987303BACKGROUND
  • Sofi F, Cesari F, Abbate R, Gensini GF, Casini A. Adherence to Mediterranean diet and health status: meta-analysis. BMJ. 2008 Sep 11;337:a1344. doi: 10.1136/bmj.a1344.

    PMID: 18786971BACKGROUND
  • Wattchow D, Heitmann P, Smolilo D, Spencer NJ, Parker D, Hibberd T, Brookes SSJ, Dinning PG, Costa M. Postoperative ileus-An ongoing conundrum. Neurogastroenterol Motil. 2021 May;33(5):e14046. doi: 10.1111/nmo.14046. Epub 2020 Nov 30.

    PMID: 33252179BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

August 2, 2026

First Posted

September 8, 2026

Study Start

January 23, 2026

Primary Completion

April 23, 2026

Study Completion

May 23, 2026

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations