Clinical trial · Interventional
Study of the Intracorporeal Versus Extracorporeal Anastomosis in Right Hemicolectomy: HEMI-D-TREND-study
A Multicenter Controlled Study of the Intracorporeal Mechanical Side-to-side Isoperistaltic Anastomosis Versus Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy: HEMI-D-TREND-study
- 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)
INTRODUCTION: Colorectal cancer is the second most frequent cancer in the Western world. Roughly a third of colorectal tumors are located in the right colon, and right hemicolectomy surgery is the treatment of choice in non-disseminated right colon cancer and other benign pathologies. Despite the introduction of laparoscopy and multimodal fast-track perioperative management programs in recent years, postoperative complication rates remain high. The most serious complication is anastomotic leak (AL), which is associated with increased mortality, longer hospital stay, and reduced quality of life due to the presence of ostomies. For a long time, the importance of ileo-colic AL was underestimated. However, the ANACO study, conducted in 52 hospitals in our environment, reported a rate of AL of 8.4% with a range of 0 to 35%. This wide range is due to the differences in the surgical procedures and anastomoses used (the surgical approach may be open or laparoscopic, and the anastomosis may be manual or mechanical, with all its variations). The results of intracorporeal laparoscopic anastomosis in the literature vary widely and, are discordant, although those reported so far estimate a DA less than 2%. But the latest publications report low rates of morbidity and of surgical space infection (SSI). The main problem with this technique is that it requires a learning curve somewhat greater than the others and its results depend on the skill of the surgeon and his casuistry. For all these reasons, it is necessary to carry out comparative studies that favor the use of this technique as gold standard. The multicentre, controlled and randomized controlled studies have the disadvantage that randomization in centers not used with one of the techniques does include a learning curve bias. Besides the fact that in a center there is a belief that one of the techniques is superior to the other, it is not ethical to randomize the techniques. This situation has encouraged us to perform a non-randomized TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND). Main objective: To assess if laparoscopic right hemicolectomy, with anastomosis, obtains better results than laparoscopic with extracorporeal anastomosis and open surgery in terms of global morbidity, surgical space infection, anastomotic leak, re-interventions and hospital stay, in the first 30 postoperative days. Secondary objectives: To analyze the rate of anastomotic leak (AL) and organ-cavitary infections in each hospital. * Compare the results obtained with those published in the literature. * Try to identify the risk factors associated with AL. * Analyze the comorbidities associated with the type of incision made for the extraction of the surgical piece, in intra and extracorporeal anastomosis
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic right hemicolectomy with extracorporeal anastomosis. | Procedure | — | UNRESOLVED |
| Laparoscopic right hemicolectomy with intracorporeal anastomosis. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic Intracorporeal anastomosis
- description
- Laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis.
- interventionNames
- Procedure: Laparoscopic right hemicolectomy with intracorporeal anastomosis.
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic extracorporeal anastomosis
- description
- Laparoscopic right hemicolectomy with extracorporeal anastomosis.
- interventionNames
- Procedure: Laparoscopic right hemicolectomy with extracorporeal anastomosis.
Primary outcomes (4)
- measure
- Percentage of anastomotic leak (AL)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with right colon neoplasia non-metastatic. * Indication of right hemicolectomy and ileo-colic anastomosis. * Over 18 years. * Scheduled surgery intervened by the team of surgeons of the Coloproctology Unit of each participating hospital. * Patients who undergone a perioperative management program corresponding to the usual practice and technique of each hospital. Exclusion Criteria: * Colon neoplasms from other locations. * T4 tumor stage and stage IV of the TNM classification. * ASA IV (American Society Anesthesiologists). * Non-optimal nutritional status (preoperative albumin ≤3.4 g / dl). * Do not sign informed consent. * Pregnant patients. * Liver cirrhosis. * Chronic renal insufficiency in dialysis treatment. * BMI \<18 and\> 35 Kg / m
References
Publications (3)
- BACKGROUNDFrasson M, Granero-Castro P, Ramos Rodriguez JL, Flor-Lorente B, Braithwaite M, Marti Martinez E, Alvarez Perez JA, Codina Cazador A, Espi A, Garcia-Granero E; ANACO Study Group. Risk factors for anastomotic leak and postoperative morbidity and mortality after elective right colectomy for cancer: results from a prospective, multicentric study of 1102 patients. Int J Colorectal Dis. 2016 Jan;31(1):105-14. doi: 10.1007/s00384-015-2376-6. Epub 2015 Aug 28. PMID 26315015
- BACKGROUNDFrasson M, Flor-Lorente B, Rodriguez JL, Granero-Castro P, Hervas D, Alvarez Rico MA, Brao MJ, Sanchez Gonzalez JM, Garcia-Granero E; ANACO Study Group. Risk Factors for Anastomotic Leak After Colon Resection for Cancer: Multivariate Analysis and Nomogram From a Multicentric, Prospective, National Study With 3193 Patients. Ann Surg. 2015 Aug;262(2):321-30. doi: 10.1097/SLA.0000000000000973. PMID 25361221
- DERIVEDSerra-Aracil X, Pascua-Sole M, Sanchez A, Gomez-Diaz CJ, Ruiz C, Espina B, Sierra JE, Lamas S, Vallverdu H, Corredera C, Veo C, Hoyuela C, Serracant A, Moreno F, Collera-Ormazabal P, Manas MJ, Merichal M, Cayetano-Paniagua L, Caro-Tarrago A; HEMI-D-TREND-study group. Intracorporeal vs extracorporeal anastomosis in laparoscopic right colectomy for colon cancer: a prospective multicenter cohort study (the Hemi-D-TREND study). Surg Endosc. 2026 Feb;40(2):1559-1571. doi: 10.1007/s00464-025-12401-0. Epub 2025 Dec 1. PMID 41326726