Post Abdominal SurgeryNCT07808281
Association Between Preoperative Mediterranean Diet Adherence and Postoperative Bowel Motility
An observational study of Post Abdominal Surgery and Gastrointestinal Motility Disorder, run by Bahçeşehir University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Abdominal Surgery, Gastrointestinal Motility Disorder, Postoperative Ileus
- How many people
- 110 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 23 Jan 2026to 23 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Previous bowel surgery within the last 3 months.
- Short bowel syndrome or conditions requiring chronic parenteral nutrition.
- Severe systemic disease.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bahcesehir University
Istanbul
İnönü University Faculty of Medicine Hospital
Malatya
About this study
Official title: Association Between Preoperative Adherence to the Mediterranean Diet and Postoperative Bowel Motility: A Prospective Observational Cohort Study
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.
Read the detailed description
Postoperative bowel motility is one of the most important indicators of recovery following abdominal surgery. Delayed gastrointestinal motility is associated with postoperative ileus, prolonged hospital stay, delayed oral feeding, and increased healthcare costs. Several factors, including surgical stress, anesthesia, inflammation, and preoperative nutritional status, may influence the recovery of bowel function after surgery.
The Mediterranean diet is characterized by a high intake of vegetables, fruits, legumes, whole grains, olive oil, nuts, and fish, and a low intake of red and processed meat. This dietary pattern provides dietary fiber, unsaturated fatty acids, polyphenols, antioxidants, and other bioactive compounds that may improve gut microbiota composition, reduce inflammation, and support normal gastrointestinal function. Previous studies have demonstrated beneficial effects of the Mediterranean diet on gastrointestinal health; however, evidence regarding its association with postoperative bowel motility remains limited.
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 laparoscopic cholecystectomy. A total of 110 participants will be enrolled after ethics committee approval. Preoperative nutritional status, dietary intake, and adherence to the Mediterranean diet will be assessed using the Mediterranean Diet Adherence Screener (MEDAS), food frequency questionnaires, and three-day dietary records. Demographic, anthropometric, clinical, and perioperative data will also be collected.
Postoperative bowel function will be prospectively evaluated by recording the time to first bowel sound, first passage of flatus, first defecation, first oral intake, and hospital discharge. Dietary nutrient intake will be analyzed using a nutrition analysis software program. The association between Mediterranean diet adherence and postoperative bowel motility outcomes will be examined using appropriate statistical methods. The findings are expected to improve understanding of the role of preoperative dietary quality in postoperative gastrointestinal recovery and may contribute to optimizing perioperative nutritional management in patients undergoing abdominal surgery.
- Keywords
- Mediterranean diet, MEDAS, Abdominal surgery, Gastrointestinal motility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Time in hours from completion of surgery, defined as the recorded time of exit from the operating room, to the first patient-reported passage of flatus.
Measured: 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
Time in hours from completion of surgery, defined as the recorded time of exit from the operating room, to the first patient-reported postoperative defecation.
Measured: 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
Time in hours from completion of surgery, defined as the recorded time of exit from the operating room, to the first documented postoperative oral fluid intake. The time of oral fluid intake was obtained from hospital records.
Measured: 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
Time in hours from completion of surgery, defined as the recorded time of exit from the operating room, until hospital discharge. The time of discharge was obtained from hospital records.
Measured: From completion of surgery until hospital discharge, assessed up to 60 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start23 Jan 2026
- Primary completion23 Apr 2026
- Study completion23 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilayda Ozturk Altuncevahir, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808281
- Sponsor's protocol ID
- E-85646034-604.01-119105
- Status last verified
- Sep 2026
- First submitted
- 2 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29244059Muller 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.
PubMed 22987303Sofi 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.
PubMed 18786971Wattchow 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.
PubMed 33252179
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preoperative Adherence to the Mediterranean Diet and Postoperative Bowel Motility: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07808281
- Acronym / sponsor ID
- E-85646034-604.01-119105
- Keywords
- Mediterranean diet, MEDAS, Abdominal surgery, Gastrointestinal motility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 May 2026 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative bowel motility is one of the most important indicators of recovery following abdominal surgery. Delayed gastrointestinal motility is associated with postoperative ileus, prolonged hospital stay, delayed oral feeding, and increased healthcare costs. Several factors, including surgical stress, anesthesia, inflammation, and preoperative nutritional status, may influence the recovery of bowel function after surgery.
The Mediterranean diet is characterized by a high intake of vegetables, fruits, legumes, whole grains, olive oil, nuts, and fish, and a low intake of red and processed meat. This dietary pattern provides dietary fiber, unsaturated fatty acids, polyphenols, antioxidants, and other bioactive compounds that may improve gut microbiota composition, reduce inflammation, and support normal gastrointestinal function. Previous studies have demonstrated beneficial effects of the Mediterranean diet on gastrointestinal health; however, evidence regarding its association with postoperative bowel motility remains limited.
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 laparoscopic cholecystectomy. A total of 110 participants will be enrolled after ethics committee approval. Preoperative nutritional status, dietary intake, and adherence to the Mediterranean diet will be assessed using the Mediterranean Diet Adherence Screener (MEDAS), food frequency questionnaires, and three-day dietary records. Demographic, anthropometric, clinical, and perioperative data will also be collected.
Postoperative bowel function will be prospectively evaluated by recording the time to first bowel sound, first passage of flatus, first defecation, first oral intake, and hospital discharge. Dietary nutrient intake will be analyzed using a nutrition analysis software program. The association between Mediterranean diet adherence and postoperative bowel motility outcomes will be examined using appropriate statistical methods. The findings are expected to improve understanding of the role of preoperative dietary quality in postoperative gastrointestinal recovery and may contribute to optimizing perioperative nutritional management in patients undergoing abdominal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to first bowel sound
Time frame: From completion of surgery until the first documented bowel sound, assessed during the postoperative hospital stay (up to 48 hours postoperatively).
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.
4 secondary outcomes
Time to first flatus
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From completion of surgery until hospital discharge, assessed up to 60 days postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 29244059Tosti 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.
- Background: PubMed 22987303Muller 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.
- Background: PubMed 18786971Sofi 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.
- Background: PubMed 33252179Wattchow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Abdominal Surgery and Gastrointestinal Motility Disorder, run by Bahçeşehir University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first bowel sound (time frame: From completion of surgery until the first documented bowel sound, assessed during the postoperative hospital stay (up to 48 hours postoperatively).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808281, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.