Anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery: a study protocol for a multicentre randomized clinical trial
Abstract Background Although many efforts have been made to decrease the incidence of anastomotic leak (AL), it remains one of the most serious complications of rectal cancer surgery. Many previous studies have reported an association between the ligation level of the inferior mesenteric artery (IMA...
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| Format: | Article |
| Language: | English |
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BMC
2022-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06862-0 |
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| author | Soo Young Lee Sohyun Kim Gyung Mo Son Hye Jin Kim Soo Yeun Park Jun Seok Park Chang Hyun Kim Gi Won Ha Kyung-Ha Lee Jin Soo Kim Ki Beom Bae Sung Uk Bae Sung Il Kang Korean ColoRectal surgeOn Study group of the Southern province (K-CROSS) |
| author_facet | Soo Young Lee Sohyun Kim Gyung Mo Son Hye Jin Kim Soo Yeun Park Jun Seok Park Chang Hyun Kim Gi Won Ha Kyung-Ha Lee Jin Soo Kim Ki Beom Bae Sung Uk Bae Sung Il Kang Korean ColoRectal surgeOn Study group of the Southern province (K-CROSS) |
| author_sort | Soo Young Lee |
| collection | DOAJ |
| description | Abstract Background Although many efforts have been made to decrease the incidence of anastomotic leak (AL), it remains one of the most serious complications of rectal cancer surgery. Many previous studies have reported an association between the ligation level of the inferior mesenteric artery (IMA) (high or low) and the incidence of AL after rectal cancer surgery. However, we cannot draw a solid conclusion because of the low quality and heterogeneity of those studies. Therefore, this study aims to investigate the impact of the IMA ligation level on the occurrence of AL after minimally invasive anterior resection of rectal cancer. Methods/design Patients with primary rectal cancer without distant metastases will be included after screening. They will be randomly assigned (1:1) to receive high or low ligation of the IMA. The primary endpoint is AL incidence; secondary endpoints are quality of life; urinary, sexual, and defecatory functions; and 3-year disease-free survival. We hypothesized that the incidence rate of AL would be 15% and 5% in the high- and low-ligation groups, respectively. With a two-sided α of 0.05 and a power of 0.8, the sample size is calculated to be 314 patients (157 per group), considering a 10% dropout rate. Discussion Although many studies have compared the short- and long-term outcomes of high and low ligation of the IMA in rectal cancer surgery, it is still debatable. This trial aims to help draw a more solid conclusion regarding the association between the IMA ligation level and AL incidence after rectal cancer surgery. We also hope to contribute to standardizing the method of rectal cancer surgery in this trial. Trial registration Clinical Research Information Service KCT0003523. Registered on February 18, 2019 |
| first_indexed | 2024-04-11T07:05:59Z |
| format | Article |
| id | doaj.art-b7ee399647b04d75b40a299aea8fc8cb |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T07:05:59Z |
| publishDate | 2022-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-b7ee399647b04d75b40a299aea8fc8cb2022-12-22T04:38:23ZengBMCTrials1745-62152022-10-012311710.1186/s13063-022-06862-0Anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery: a study protocol for a multicentre randomized clinical trialSoo Young Lee0Sohyun Kim1Gyung Mo Son2Hye Jin Kim3Soo Yeun Park4Jun Seok Park5Chang Hyun Kim6Gi Won Ha7Kyung-Ha Lee8Jin Soo Kim9Ki Beom Bae10Sung Uk Bae11Sung Il Kang12Korean ColoRectal surgeOn Study group of the Southern province (K-CROSS)Department of Surgery, Chonnam National University Hwasun Hospital and Medical SchoolDepartment of Surgery, College of Medicine, Yeungnam UniversityDepartment of Surgery, Pusan National University Yangsan Hospital, School of Medicine, Pusan National UniversityColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National UniversityColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National UniversityColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National UniversityDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical SchoolResearch Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University HospitalDepartment of Surgery, Chungnam National University Hospital & College of Medicine, Chungnam National UniversityDepartment of Surgery, Chungnam National University Sejong Hospital & College of Medicine, Chungnam National UniversityDepartment of Surgery, Paik Institute for Clinical Research, Inje University, College of Medicine, Inje University, Busan Paik HospitalDepartment of Surgery, School of Medicine, Keimyung University and Dongsan Medical CenterDepartment of Surgery, College of Medicine, Yeungnam UniversityAbstract Background Although many efforts have been made to decrease the incidence of anastomotic leak (AL), it remains one of the most serious complications of rectal cancer surgery. Many previous studies have reported an association between the ligation level of the inferior mesenteric artery (IMA) (high or low) and the incidence of AL after rectal cancer surgery. However, we cannot draw a solid conclusion because of the low quality and heterogeneity of those studies. Therefore, this study aims to investigate the impact of the IMA ligation level on the occurrence of AL after minimally invasive anterior resection of rectal cancer. Methods/design Patients with primary rectal cancer without distant metastases will be included after screening. They will be randomly assigned (1:1) to receive high or low ligation of the IMA. The primary endpoint is AL incidence; secondary endpoints are quality of life; urinary, sexual, and defecatory functions; and 3-year disease-free survival. We hypothesized that the incidence rate of AL would be 15% and 5% in the high- and low-ligation groups, respectively. With a two-sided α of 0.05 and a power of 0.8, the sample size is calculated to be 314 patients (157 per group), considering a 10% dropout rate. Discussion Although many studies have compared the short- and long-term outcomes of high and low ligation of the IMA in rectal cancer surgery, it is still debatable. This trial aims to help draw a more solid conclusion regarding the association between the IMA ligation level and AL incidence after rectal cancer surgery. We also hope to contribute to standardizing the method of rectal cancer surgery in this trial. Trial registration Clinical Research Information Service KCT0003523. Registered on February 18, 2019https://doi.org/10.1186/s13063-022-06862-0Rectal cancerAnastomotic leakInferior mesenteric artery ligationRandomized controlled trial |
| spellingShingle | Soo Young Lee Sohyun Kim Gyung Mo Son Hye Jin Kim Soo Yeun Park Jun Seok Park Chang Hyun Kim Gi Won Ha Kyung-Ha Lee Jin Soo Kim Ki Beom Bae Sung Uk Bae Sung Il Kang Korean ColoRectal surgeOn Study group of the Southern province (K-CROSS) Anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery: a study protocol for a multicentre randomized clinical trial Trials Rectal cancer Anastomotic leak Inferior mesenteric artery ligation Randomized controlled trial |
| title | Anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery: a study protocol for a multicentre randomized clinical trial |
| title_full | Anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery: a study protocol for a multicentre randomized clinical trial |
| title_fullStr | Anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery: a study protocol for a multicentre randomized clinical trial |
| title_full_unstemmed | Anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery: a study protocol for a multicentre randomized clinical trial |
| title_short | Anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery: a study protocol for a multicentre randomized clinical trial |
| title_sort | anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery a study protocol for a multicentre randomized clinical trial |
| topic | Rectal cancer Anastomotic leak Inferior mesenteric artery ligation Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-022-06862-0 |
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