The articulated laparoscopic total mesorectal excision for rectal cancer (ATOME trial): a single-arm, prospective trial with pre-specified comparison to robotic surgery
Abstract Background Laparoscopic total mesorectal excision (TME) has become the standard surgical treatment for rectal cancers, despite being a technically challenging procedure due to the straight and rigid nature of the laparoscopic instrument within a narrow bony pelvis. A robotic system with mul...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-07-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-025-08847-1 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849341600009814016 |
|---|---|
| author | Kyeong Eui Kim Sung Uk Bae Seung Hyun Lee Dae-Ro Lim Heon-Kyun Ha Jin Kim Hyo Seon Ryu Soo Yeon Park Sung Il Kang Gyung Mo Son Soo Young Lee Chang Hyun Kim Kyung Ha Lee Gi Won Ha Hye Jin Kim Woong Bae Ji Woo Ram Kim Sang Hee Kang Nak Song Sung Ji Hoon Kim Taek-Gu Lee Myung Jo Kim Woon Kyung Jeong Seong Kyu Baek |
| author_facet | Kyeong Eui Kim Sung Uk Bae Seung Hyun Lee Dae-Ro Lim Heon-Kyun Ha Jin Kim Hyo Seon Ryu Soo Yeon Park Sung Il Kang Gyung Mo Son Soo Young Lee Chang Hyun Kim Kyung Ha Lee Gi Won Ha Hye Jin Kim Woong Bae Ji Woo Ram Kim Sang Hee Kang Nak Song Sung Ji Hoon Kim Taek-Gu Lee Myung Jo Kim Woon Kyung Jeong Seong Kyu Baek |
| author_sort | Kyeong Eui Kim |
| collection | DOAJ |
| description | Abstract Background Laparoscopic total mesorectal excision (TME) has become the standard surgical treatment for rectal cancers, despite being a technically challenging procedure due to the straight and rigid nature of the laparoscopic instrument within a narrow bony pelvis. A robotic system with multi-joint instruments, three-dimensional vision, and improved ergonomics was introduced, however it is not yet cost-effective. Recently, several articulating laparoscopic instruments have been developed and introduced as substitutes for multi-joint robotic system instruments. The prospective study aims to demonstrate that the positive rate of circumferential resection margin following laparoscopic surgery with articulated laparoscopic instruments is non-inferior to that of robotic surgery in the treatment of rectal cancer. Methods/design Patients with primary rectal cancer who are treated with low anterior resection using articulated laparoscopic instruments will be included in the study. Participating colorectal surgeons must use articulated laparoscopic instruments at least during TME. We hypothesize that the positive rate of circumferential resection margin after robotic surgery will be 6%, 3 based on the previous studies. A trial with 157 patients contributing to the primary outcome analysis would have 80% power to declare non-inferiority with a 5.2% non-inferiority margin, assuming a 10% dropout rate. To compare laparoscopic TME group and robotic TME group, we adjust for variables such as gender, T stage, N stage, sphincter saving status, and preoperative chemoradiation using propensity score matching. The primary end-point of this study is cicumferential resection margin after surgery. Discussion Based on this study, we hope to demonstrate the efficacy and viability of articulated laparoscopic instruments in the treatment of rectal cancer at a lower cost than robotic surgery. Trial registration Clinical Research Information Service KCT0008896. Registered on 15 August 2023. |
| format | Article |
| id | doaj-art-42a4be77d3e546d48e1dd90cb014359a |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-42a4be77d3e546d48e1dd90cb014359a2025-08-20T03:43:36ZengBMCTrials1745-62152025-07-012611710.1186/s13063-025-08847-1The articulated laparoscopic total mesorectal excision for rectal cancer (ATOME trial): a single-arm, prospective trial with pre-specified comparison to robotic surgeryKyeong Eui Kim0Sung Uk Bae1Seung Hyun Lee2Dae-Ro Lim3Heon-Kyun Ha4Jin Kim5Hyo Seon Ryu6Soo Yeon Park7Sung Il Kang8Gyung Mo Son9Soo Young Lee10Chang Hyun Kim11Kyung Ha Lee12Gi Won Ha13Hye Jin Kim14Woong Bae Ji15Woo Ram Kim16Sang Hee Kang17Nak Song Sung18Ji Hoon Kim19Taek-Gu Lee20Myung Jo Kim21Woon Kyung Jeong22Seong Kyu Baek23Department of Surgery, School of Medicine, Keimyung University and Dongsan Medical CenterDepartment of Surgery, School of Medicine, Keimyung University and Dongsan Medical CenterDepartment of Surgery, Kosin University College of MedicineDivision of Colon and Rectal Surgery, Department of Surgery, Soonchunhyung University College of Medicine, Soonchunhyung Univerisity Bucheon HospitalDepartment of Surgery, Chung-Ang University HospitalDepartment of Surgery, Korea University College of MedicineDepartment of Surgery, Korea University College of MedicineColorectal Cancer Center, School of Medicine, Kyungpook National University Chilgok Hospital, Kyungpook National UniversityDepartment of Surgery, Yeungnam University Medical Center, Yeungnam University College of MedicineDepartment of Surgery, Pusan National University Yangsan Hospital, Pusan National University School of MedicineDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical SchoolDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical SchoolDepartment of Surgery, Chungnam National University College of MedicineResearch Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University HospitalColorectal Cancer Center, School of Medicine, Kyungpook National University Chilgok Hospital, Kyungpook National UniversityDivision of Colon and Rectal Surgery, Korea University Ansan HospitalDivision of Colorectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of MedicineDepartment of Surgery, Korea University College of MedicineDepartment of Surgery, Konyang University HospitalDivision of Colorectal Surgery, Department of Surgery, Incheon St. Mary’s Hospital, the Catholic University of KoreaDepartment of Surgery, Chungbuk National University Hospital, Chungbuk National University College of MedicineDepartment of Surgery, Chungbuk National University Hospital, Chungbuk National University College of MedicineDepartment of Surgery, School of Medicine, Keimyung University and Dongsan Medical CenterDepartment of Surgery, School of Medicine, Keimyung University and Dongsan Medical CenterAbstract Background Laparoscopic total mesorectal excision (TME) has become the standard surgical treatment for rectal cancers, despite being a technically challenging procedure due to the straight and rigid nature of the laparoscopic instrument within a narrow bony pelvis. A robotic system with multi-joint instruments, three-dimensional vision, and improved ergonomics was introduced, however it is not yet cost-effective. Recently, several articulating laparoscopic instruments have been developed and introduced as substitutes for multi-joint robotic system instruments. The prospective study aims to demonstrate that the positive rate of circumferential resection margin following laparoscopic surgery with articulated laparoscopic instruments is non-inferior to that of robotic surgery in the treatment of rectal cancer. Methods/design Patients with primary rectal cancer who are treated with low anterior resection using articulated laparoscopic instruments will be included in the study. Participating colorectal surgeons must use articulated laparoscopic instruments at least during TME. We hypothesize that the positive rate of circumferential resection margin after robotic surgery will be 6%, 3 based on the previous studies. A trial with 157 patients contributing to the primary outcome analysis would have 80% power to declare non-inferiority with a 5.2% non-inferiority margin, assuming a 10% dropout rate. To compare laparoscopic TME group and robotic TME group, we adjust for variables such as gender, T stage, N stage, sphincter saving status, and preoperative chemoradiation using propensity score matching. The primary end-point of this study is cicumferential resection margin after surgery. Discussion Based on this study, we hope to demonstrate the efficacy and viability of articulated laparoscopic instruments in the treatment of rectal cancer at a lower cost than robotic surgery. Trial registration Clinical Research Information Service KCT0008896. Registered on 15 August 2023.https://doi.org/10.1186/s13063-025-08847-1Rectal neoplasmsLaparoscopyColorectal surgeryTreatment outcomeSurgical instruments |
| spellingShingle | Kyeong Eui Kim Sung Uk Bae Seung Hyun Lee Dae-Ro Lim Heon-Kyun Ha Jin Kim Hyo Seon Ryu Soo Yeon Park Sung Il Kang Gyung Mo Son Soo Young Lee Chang Hyun Kim Kyung Ha Lee Gi Won Ha Hye Jin Kim Woong Bae Ji Woo Ram Kim Sang Hee Kang Nak Song Sung Ji Hoon Kim Taek-Gu Lee Myung Jo Kim Woon Kyung Jeong Seong Kyu Baek The articulated laparoscopic total mesorectal excision for rectal cancer (ATOME trial): a single-arm, prospective trial with pre-specified comparison to robotic surgery Trials Rectal neoplasms Laparoscopy Colorectal surgery Treatment outcome Surgical instruments |
| title | The articulated laparoscopic total mesorectal excision for rectal cancer (ATOME trial): a single-arm, prospective trial with pre-specified comparison to robotic surgery |
| title_full | The articulated laparoscopic total mesorectal excision for rectal cancer (ATOME trial): a single-arm, prospective trial with pre-specified comparison to robotic surgery |
| title_fullStr | The articulated laparoscopic total mesorectal excision for rectal cancer (ATOME trial): a single-arm, prospective trial with pre-specified comparison to robotic surgery |
| title_full_unstemmed | The articulated laparoscopic total mesorectal excision for rectal cancer (ATOME trial): a single-arm, prospective trial with pre-specified comparison to robotic surgery |
| title_short | The articulated laparoscopic total mesorectal excision for rectal cancer (ATOME trial): a single-arm, prospective trial with pre-specified comparison to robotic surgery |
| title_sort | articulated laparoscopic total mesorectal excision for rectal cancer atome trial a single arm prospective trial with pre specified comparison to robotic surgery |
| topic | Rectal neoplasms Laparoscopy Colorectal surgery Treatment outcome Surgical instruments |
| url | https://doi.org/10.1186/s13063-025-08847-1 |
| work_keys_str_mv | AT kyeongeuikim thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT sungukbae thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT seunghyunlee thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT daerolim thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT heonkyunha thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT jinkim thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT hyoseonryu thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT sooyeonpark thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT sungilkang thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT gyungmoson thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT sooyounglee thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT changhyunkim thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT kyunghalee thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT giwonha thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT hyejinkim thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT woongbaeji thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT wooramkim thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT sangheekang thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT naksongsung thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT jihoonkim thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT taekgulee thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT myungjokim thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT woonkyungjeong thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT seongkyubaek thearticulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT kyeongeuikim articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT sungukbae articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT seunghyunlee articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT daerolim articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT heonkyunha articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT jinkim articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT hyoseonryu articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT sooyeonpark articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT sungilkang articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT gyungmoson articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT sooyounglee articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT changhyunkim articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT kyunghalee articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT giwonha articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT hyejinkim articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT woongbaeji articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT wooramkim articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT sangheekang articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT naksongsung articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT jihoonkim articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT taekgulee articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT myungjokim articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT woonkyungjeong articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery AT seongkyubaek articulatedlaparoscopictotalmesorectalexcisionforrectalcanceratometrialasinglearmprospectivetrialwithprespecifiedcomparisontoroboticsurgery |