Perioperative Outcomes Clinical Trial
Official title:
Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision: a Retrospective Multicenter Study With Propensity Score Matching
NCT number | NCT05457426 |
Other study ID # | 20220623 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2022 |
Est. completion date | June 22, 2022 |
Verified date | July 2022 |
Source | Third Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
the investigators performed a retrospective multicenter propensity score matching study. From July 2016 to July 2021, 382 consecutive patients from different Chinese surgical departments were available for inclusion out of an initial cohort of 412, who underwent robotic or laparoscopic right hemicolectomy with CME.
Status | Completed |
Enrollment | 382 |
Est. completion date | June 22, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Adenocarcinoma was confirmed by preoperative colonoscopy and it was located in the right colon. 2. Preoperative enhanced abdominal CT examination showed no invasion of abdominal wall or adjacent organs. 3. The patient underwent robotic or laparoscopic right hemicolectomy with CME. Exclusion Criteria: 1. Multiple primary colorectal tumors 2. Metastasis to abdominal 3. Pelvic or distant organs 4. Accompanied with bowel obstruction or perforation 5. Neuroendocrine tumors 6. Lymphomas 7. Other malignant tumors. |
Country | Name | City | State |
---|---|---|---|
China | No. 940 Hospital of Joint Logistics Support Foce of Chinese People's Liberation Army | Lanzhou | Gansu |
China | Chongqing University Three Gorges Hospital | Wanzhou | Chongqing |
China | Army Medical Center | Yuzhong | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Third Military Medical University |
China,
Ferri V, Quijano Y, Nuñez J, Caruso R, Duran H, Diaz E, Fabra I, Malave L, Isernia R, d'Ovidio A, Agresott R, Gomez P, Isojo R, Vicente E. Robotic-assisted right colectomy versus laparoscopic approach: case-matched study and cost-effectiveness analysis. J — View Citation
Spinoglio G, Bianchi PP, Marano A, Priora F, Lenti LM, Ravazzoni F, Petz W, Borin S, Ribero D, Formisano G, Bertani E. Robotic Versus Laparoscopic Right Colectomy with Complete Mesocolic Excision for the Treatment of Colon Cancer: Perioperative Outcomes a — View Citation
Yozgatli TK, Aytac E, Ozben V, Bayram O, Gurbuz B, Baca B, Balik E, Hamzaoglu I, Karahasanoglu T, Bugra D. Robotic Complete Mesocolic Excision Versus Conventional Laparoscopic Hemicolectomy for Right-Sided Colon Cancer. J Laparoendosc Adv Surg Tech A. 201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | diseasefree survival(months) | Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it. | until July 2021 | |
Primary | overall survival(months) | Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it. | until July 2021 | |
Secondary | conversion rates | the incidence of a conversion to open surgery | during the surgery | |
Secondary | operative time | the miniutes of surgery from skin to skin | during the surgery | |
Secondary | estimated blood loss | the mililiter of the blood loss during surgery | during the surgery | |
Secondary | oral retake | the patients begin to recover intake | up to 30 days after surgery | |
Secondary | time to return to bowel function | the patients begin to recover bowel function | up to 30 days after surgery | |
Secondary | length of stay | the days of hospital stay | up to 30 days after surgery | |
Secondary | total hospitalization cost | the total cost of this treatment by RMB | up to 30 days after surgery | |
Secondary | complications | Postoperative complications, such as ileus, anastomotic leak, small intestinal obstruction, bleeding and so on. Number of Participants with complications will be recorded. | up to 30 days after surgery | |
Secondary | harvest lymph nodes | the number of harvest lymph nodes in postoperative pathological report | up to 7 days after surgery | |
Secondary | lymph node metastasis | the number of patients with lymph node metastasis | up to 7 days after surgery |
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