Clinical trial · Observational
The Patient in Laparoscopic Colon Surgery:Impact of Comorbidities,Frailty,Malnutrition and Sarcopenia on Short-term Mortality
The Impact of Comorbidities, Frailty Malnutrition and Sarcopenia on Short-term Mortality in Patients Undergoing Laparoscopic Colon Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There are many factors involved in outlining the patient's profile and in defining which factors can be configured as risks related to the surgical act; for the modern surgeon it is no longer possible to identify the patient at risk of complications based on the mere age or some comorbidities historically considered more influential on the surgical outcome, but each patient must be evaluated in its entirety including age, fragility, comorbidity, state nutritional and sarcopenia and, if necessary, implementing preoperative therapeutic strategies aimed at minimizing the impact of some of these factors on the outcome of surgery. Our study aimed at creating, if possible, an "identikit" of the patient who is more likely to have serious postoperative complications; in order to improve the therapeutic decision and the approach to patients with severe surgical risk since choosing the right treatment for the right patient is essential to obtain a good result.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Comorbidities and Coexisting Conditions | — | UNRESOLVED | — |
| Malnutrition | — | UNRESOLVED | — |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- short-term mortality rates within 30 days from surgery
- timeFrame
- Within 30 days from surgery
- description
- short-term (30 days after surgery) mortality rate in patients undergoing resective colorectal surgery
- measure
- correlation between the development of a postoperative complication within 30 days from surgery and patient-related characteristics (comorbidity, frailty, malnutrition and sarcopenia)
- timeFrame
- Preoperative assessment of pre-existing comorbidities, the frailty, malnutrition and sarcopenia status and within 30 days from surgery for Clavien Dindo complication score
- description
- presence of a proportional correlation between the development of postoperative complications and its the extent within 30 days from surgery assessed according to the Clavien Dindo scale (mild complications 1-2; severe complications 3-4-5) and patient-related factors that may have influenced the occurrence of postoperative complications. For assessing the pre-existing comorbidities we used the Charlson Comorbidity Index (CCI), the level of frailty will be assessed by the 11-items Frailty Index, malnutrition is assessed by two scores (M.U.S.T. and NRS-2002) allowing a stratification of the patient's risk of malnutrition. In addition, the level of preoperative sarcopenia present on computed tomography will also be assessed using specific software to calculate the average density of the psoas muscles, Psoas Index (PI) and Total Psoas Area (TPA).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age \> 18 y.o. * colorectal surgery with laparoscopic technique according to the following surgical procedures: right hemicolectomy, left hemicolectomy, segmental resection of the transverse colon, sigmoidectomy. * elective surgery Exclusion Criteria: * colorectal surgery with laparotomy technique * emergency surgery * surgical equipe different from the one operating in the U.O Chirurgia 1 at Sant'Anna University Hospital in Ferrara
References
Publications (19)
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- BACKGROUNDDannhauser A, Van Zyl JM, Nel CJ. Preoperative nutritional status and prognostic nutritional index in patients with benign disease undergoing abdominal operations--Part I. J Am Coll Nutr. 1995 Feb;14(1):80-90. doi: 10.1080/07315724.1995.10718477. PMID 7706616
- BACKGROUNDFukuda Y, Yamamoto K, Hirao M, Nishikawa K, Maeda S, Haraguchi N, Miyake M, Hama N, Miyamoto A, Ikeda M, Nakamori S, Sekimoto M, Fujitani K, Tsujinaka T. Prevalence of Malnutrition Among Gastric Cancer Patients Undergoing Gastrectomy and Optimal Preoperative Nutritional Support for Preventing Surgical Site Infections. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S778-85. doi: 10.1245/s10434-015-4820-9. Epub 2015 Aug 19. PMID 26286199
- BACKGROUNDBozzetti F, Gianotti L, Braga M, Di Carlo V, Mariani L. Postoperative complications in gastrointestinal cancer patients: the joint role of the nutritional status and the nutritional support. Clin Nutr. 2007 Dec;26(6):698-709. doi: 10.1016/j.clnu.2007.06.009. Epub 2007 Aug 1. PMID 17683831