A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Conditions

Colorectal Cancer

Keywords

colorectal cancer, laparoscopic surgery, randomized controlled trial, oncological outcome

Brief summary

The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

Detailed description

The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

Shuji Saito, Tomonori Akagi, Hiroshi Katayama, Masashi Wakabayashi, Masafumi Inomata et al. (18 authors)

Annals of Gastroenterological Surgery2021-08-0923 citations

10.1002/ags3.12475

Risk factors for early postoperative complications after D3 dissection for stage II or III colon cancer: Supplementary analysis of a multicenter randomized controlled trial in Japan (JCOG0404).

Nishizawa Y, Akagi T, Inomata M, Katayama H, Mizusawa J, Yamamoto S, Ito M, Masaki T, Watanabe M, Shimada Y, Kitano S.

2019-04-0412 citations

10.1002/ags3.12246

Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404.

Fujii S, Akagi T, Inomata M, Katayama H, Mizusawa J, Ota M, Saito S, Kinugasa Y, Yamaguchi S, Sato T, Kitano S, Japan Clinical Oncology Group.

2019-03-2623 citations

10.1002/ags3.12245

Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial.

Kitano S, Inomata M, Mizusawa J, Katayama H, Watanabe M, Yamamoto S, Ito M, Saito S, Fujii S, Konishi F, Saida Y, Hasegawa H, Akagi T, Sugihara K, Yamaguchi T, Masaki T, Fukunaga Y, Murata K, Okajima M, Moriya Y, Shimada Y.

2017-02-02193 citations

10.1016/s2468-1253(16)30207-2

A randomized controlled trial to evaluate laparoscopic versus open with Japanese D3 dissection for stage II,III colorectal cancer (CRC): First efficacy results from Japan Clinical Oncology Group Study JCOG0404.

Tomonori Akagi, Masafumi Inomata, Hiroshi Katayama, Junki Mizusawa, Tomohiro Yamaguchi et al. (20 authors)

Journal of Clinical Oncology2015-05-202 citations

10.1200/jco.2015.33.15_suppl.3577

Interventions

PROCEDUREopen colectomy

Procedure/Surgery: open colectomy

PROCEDURElaparoscopic colectomy

Procedure/Surgery: laparoscopic colectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

1. Histologically proven colorectal carcinoma 2. Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon 3. T3 or deeper lesion without involvement of other organs 4. Without multiple lesion other than carcinoma in situ 5. Cancer classified as N0-2 and M0, according to the TNM classification system 6. Tumor size \< 8 cm 7. No bowel obstruction 8. Age 20 \< and \> 75 years 9. Sufficient organ function 10. No history of gastrointestinal surgery 11. No history of chemotherapy or radiotherapy 12. Provided written informed consent

Exclusion criteria

1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2. Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease 3. Pregnant or lactating women 4. Severe mental disease 5. Continuous systemic steroid therapy

Design outcomes

Primary

Measure	Time frame
Overall survival	During the study conduct

Secondary

Measure	Time frame
Relapse-free survival	During the study conduct
Short-term clinical outcomes	time to 1st discharge after operation
Adverse events	During the study conduct
The proportion of conversion from LAP to OPEN	operation day
The proportion of completion of LAP	operation day

Countries

Japan

Outcome results

None listed