Minimally Invasive Surgical ProceduresNCT07756450
Impact of Obesity on Textbook Outcome Achievement in Minimally Invasive Colorectal Cancer Surgery
An observational study of Minimally Invasive Surgical Procedures and Colo-rectal Cancer, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Textbook Outcome (TO) is a composite quality measure that integrates multiple perioperative endpoints to provide a comprehensive assessment of surgical quality. Although obesity has been associated with adverse outcomes after colorectal surgery, its impact on achieving TO remains unclear, particularly in the era of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimally Invasive Surgical Procedures, Colo-rectal Cancer
- How many people
- 305 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 15 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent minimally invasive colorectal surgery between 2021 and 2025
Who may be able to join
- Patients who underwent curative minimally invasive colorectal cancer resection at a single tertiary referral center between 2021 and 2025 were retrospectively reviewed. All patients were ≥18 years of age.
Who cannot join
- Patients undergoing metastatic resections, abdominoperineal resection (APR), Hartmann's procedure, multisegmental or total colectomy, transanal minimally invasive surgery (TAMIS), or palliative procedures were excluded from the analysis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Training and Research Hospital, University of Health Sciences
Istanbul, Bakirköy, 34147
About this study
Textbook Outcome (TO) is a composite quality measure that integrates multiple perioperative endpoints to provide a comprehensive assessment of surgical quality. Although obesity has been associated with adverse outcomes after colorectal surgery, its impact on achieving TO remains unclear, particularly in the era of minimally invasive surgery. This study aimed to evaluate the association between body mass index (BMI) and TO achievement in patients undergoing minimally invasive colorectal cancer surgery.
Read the detailed description
This retrospective observational study aims to evaluate the association between body mass index (BMI) and achievement of Textbook Outcome (TO) in patients undergoing minimally invasive colorectal cancer surgery. Patients who underwent curative minimally invasive colorectal cancer resection at a single tertiary referral center between 2021 and 2025 will be retrospectively evaluated. Patients will be categorized according to BMI as non-obese (BMI <30 kg/m²) and obese (BMI ≥30 kg/m²). Textbook Outcome will be assessed as a composite measure including R0 resection, retrieval of at least 12 lymph nodes, absence of major postoperative complications (Clavien-Dindo grade ≥IIIa), hospital stay ≤14 days, absence of 30-day readmission, and absence of 30-day mortality. The study will investigate whether BMI is associated with failure to achieve Textbook Outcome and will evaluate independent predictors of TO failure using multivariable logistic regression analysis.
- Keywords
- minimal invasive colorectal surgery, obesity, body mass index, textbook outcome
- Medical subject headings
- Colonic Neoplasms, Obesity
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 |
|---|---|---|
| non-obese grup | BMI <30 kg/m² | |
| obese group | BMI ≥30 kg/m² |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic, clinical, and perioperative characteristics
Age, sex, comorbidity burden assessed by the age-adjusted Charlson Comorbidity Index (CCI) , ASA score , tumor location, neoadjuvant therapy, surgical approach, or postoperative complication rates
Measured: 30 days
Secondary outcomes (1)
Textbook Outcome
R0 resection, LN retrieval (≥12), Major Complication (CD≥3), LOS<14 days, No readmission, No mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Jan 2021
- Primary completion31 Dec 2025
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Minimally Invasive Surgical ProceduresStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756450
- Sponsor's protocol ID
- obemics
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lara-Romero C, Vilches A, Caunedo-Alvarez A, Hergueta-Delgado P, Lavin-Castejon I, Andrade-Bellido R, Alcain-Martinez G. Better recurrence-free survival after stent bridge to surgery compared to emergency surgery for obstructive left-sided colonic cancer in patients with stage III status of the American Joint Committee on Cancer (AJCC): a bicentric retrospective study. Int J Colorectal Dis. 2019 Jul;34(7):1241-1250. doi: 10.1007/s00384-019-03318-x. Epub 2019 May 25.
PubMed 31129696Hirata Y, Agnes A, Arvide EM, Robinson KA, To C, Griffith HL, LaRose MD, Munder KM, Mansfield P, Badgwell BD, Ikoma N. Short-Term and Textbook Surgical Outcomes During the Implementation of a Robotic Gastrectomy Program. J Gastrointest Surg. 2023 Jun;27(6):1089-1097. doi: 10.1007/s11605-023-05627-7. Epub 2023 Mar 14.
PubMed 36917404Roh CK, Lee S, Son SY, Hur H, Han SU. Textbook outcome and survival of robotic versus laparoscopic total gastrectomy for gastric cancer: a propensity score matched cohort study. Sci Rep. 2021 Jul 28;11(1):15394. doi: 10.1038/s41598-021-95017-3.
PubMed 34321568Bolger JC, Al Azzawi M, Whooley J, Bolger EM, Trench L, Allen J, Kelly ME, Brosnan C, Arumugasamy M, Robb WB. Surgery by a minimally invasive approach is associated with improved textbook outcomes in oesophageal and gastric cancer. Eur J Surg Oncol. 2021 Sep;47(9):2332-2339. doi: 10.1016/j.ejso.2021.03.240. Epub 2021 Mar 17.
PubMed 33766456Busweiler LA, Schouwenburg MG, van Berge Henegouwen MI, Kolfschoten NE, de Jong PC, Rozema T, Wijnhoven BP, van Hillegersberg R, Wouters MW, van Sandick JW; Dutch Upper Gastrointestinal Cancer Audit (DUCA) group. Textbook outcome as a composite measure in oesophagogastric cancer surgery. Br J Surg. 2017 May;104(6):742-750. doi: 10.1002/bjs.10486. Epub 2017 Feb 27.
PubMed 28240357
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obesity on Textbook Outcome Achievement in Minimally Invasive Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07756450
- Acronym / sponsor ID
- obemics
- Keywords
- minimal invasive colorectal surgery, obesity, body mass index, textbook outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 10 Aug 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.
Textbook Outcome (TO) is a composite quality measure that integrates multiple perioperative endpoints to provide a comprehensive assessment of surgical quality. Although obesity has been associated with adverse outcomes after colorectal surgery, its impact on achieving TO remains unclear, particularly in the era of minimally invasive surgery. This study aimed to evaluate the association between body mass index (BMI) and TO achievement in patients undergoing minimally invasive colorectal cancer surgery.
Detailed description
This retrospective observational study aims to evaluate the association between body mass index (BMI) and achievement of Textbook Outcome (TO) in patients undergoing minimally invasive colorectal cancer surgery. Patients who underwent curative minimally invasive colorectal cancer resection at a single tertiary referral center between 2021 and 2025 will be retrospectively evaluated. Patients will be categorized according to BMI as non-obese (BMI <30 kg/m²) and obese (BMI ≥30 kg/m²). Textbook Outcome will be assessed as a composite measure including R0 resection, retrieval of at least 12 lymph nodes, absence of major postoperative complications (Clavien-Dindo grade ≥IIIa), hospital stay ≤14 days, absence of 30-day readmission, and absence of 30-day mortality. The study will investigate whether BMI is associated with failure to achieve Textbook Outcome and will evaluate independent predictors of TO failure using multivariable logistic regression analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-obese grup | – | –BMI <30 kg/m² |
| obese group | – | –BMI ≥30 kg/m² |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent minimally invasive colorectal surgery between 2021 and 2025
Key inclusion criteria (1 listed)
- Patients who underwent curative minimally invasive colorectal cancer resection at a single tertiary referral center between 2021 and 2025 were retrospectively reviewed. All patients were ≥18 years of age.
Key exclusion criteria (1 listed)
- Patients undergoing metastatic resections, abdominoperineal resection (APR), Hartmann's procedure, multisegmental or total colectomy, transanal minimally invasive surgery (TAMIS), or palliative procedures were excluded from the analysis.
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
Demographic, clinical, and perioperative characteristics
Time frame: 30 days
Age, sex, comorbidity burden assessed by the age-adjusted Charlson Comorbidity Index (CCI) , ASA score , tumor location, neoadjuvant therapy, surgical approach, or postoperative complication rates
1 secondary outcome
Textbook Outcome
Time frame: 30 days
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 26 Aug 2026.
- Background: PubMed 31129696Lara-Romero C, Vilches A, Caunedo-Alvarez A, Hergueta-Delgado P, Lavin-Castejon I, Andrade-Bellido R, Alcain-Martinez G. Better recurrence-free survival after stent bridge to surgery compared to emergency surgery for obstructive left-sided colonic cancer in patients with stage III status of the American Joint Committee on Cancer (AJCC): a bicentric retrospective study. Int J Colorectal Dis. 2019 Jul;34(7):1241-1250. doi: 10.1007/s00384-019-03318-x. Epub 2019 May 25.
- Background: PubMed 36917404Hirata Y, Agnes A, Arvide EM, Robinson KA, To C, Griffith HL, LaRose MD, Munder KM, Mansfield P, Badgwell BD, Ikoma N. Short-Term and Textbook Surgical Outcomes During the Implementation of a Robotic Gastrectomy Program. J Gastrointest Surg. 2023 Jun;27(6):1089-1097. doi: 10.1007/s11605-023-05627-7. Epub 2023 Mar 14.
- Background: PubMed 34321568Roh CK, Lee S, Son SY, Hur H, Han SU. Textbook outcome and survival of robotic versus laparoscopic total gastrectomy for gastric cancer: a propensity score matched cohort study. Sci Rep. 2021 Jul 28;11(1):15394. doi: 10.1038/s41598-021-95017-3.
- Background: PubMed 33766456Bolger JC, Al Azzawi M, Whooley J, Bolger EM, Trench L, Allen J, Kelly ME, Brosnan C, Arumugasamy M, Robb WB. Surgery by a minimally invasive approach is associated with improved textbook outcomes in oesophageal and gastric cancer. Eur J Surg Oncol. 2021 Sep;47(9):2332-2339. doi: 10.1016/j.ejso.2021.03.240. Epub 2021 Mar 17.
- Background: PubMed 28240357Busweiler LA, Schouwenburg MG, van Berge Henegouwen MI, Kolfschoten NE, de Jong PC, Rozema T, Wijnhoven BP, van Hillegersberg R, Wouters MW, van Sandick JW; Dutch Upper Gastrointestinal Cancer Audit (DUCA) group. Textbook outcome as a composite measure in oesophagogastric cancer surgery. Br J Surg. 2017 May;104(6):742-750. doi: 10.1002/bjs.10486. Epub 2017 Feb 27.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimally Invasive Surgical Procedures and Colo-rectal Cancer, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site 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 1 inclusion and 1 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Demographic, clinical, and perioperative characteristics (time frame: 30 days). 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 NCT07756450, which also lists 5 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 26 Aug 2026.