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A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

ABSTRACT: Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer.This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-? [TNF-?]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years.This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is feasible for the radical resection of rectosigmoid cancer and offers short-term safety and long-term oncological safety comparable to that of CLS, and that SILS plus one offers better cosmetic results and faster convalescence compared to CLS.ClinicalTrials.gov: NCT02117557 (registered on 16 April 2014).

SUBMITTER: Wang Y

PROVIDER: S-EPMC4663734 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

Wang Yanan Y Liu Ruoyan R Zhang Ze Z Xue Qi Q Yan Jun J Yu Jiang J Liu Hao H Zhao Liying L Mou Tingyu T Deng Haijun H Li Guoxin G

Trials 20151130

<h4>Background</h4>Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer.<h4>Methods/design</h4>This is a single-center, open- ...[more]

PMID: 26620555

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Project description:BackgroundA recent study shows that a multifaceted strategy using an individualised intra-abdominal pressure titration strategy during colorectal laparoscopic surgery results in an acceptable workspace at low intra-abdominal pressure in most patients. The multifaceted strategy, focused on lower to individualised intra-abdominal pressures, includes prestretching the abdominal wall during initial insufflation, deep neuromuscular blockade, low tidal volume ventilation settings and a modified lithotomy position. The study presented here tests the hypothesis that this strategy improves outcomes of patients scheduled for colorectal laparoscopic surgery.MethodsThe Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery versus Standard Therapy (IPPCollapse-II) study is a multicentre, two-arm, parallel-group, single-blinded randomised 1:1 clinical study that runs in four academic hospitals in Spain. Patients scheduled for colorectal laparoscopic surgery with American Society of Anesthesiologists classification I to III who are aged > 18 years and are without cognitive deficits are randomised to an individualised pneumoperitoneum pressure strategy (the intervention group) or to a conventional pneumoperitoneum pressure strategy (the control group). The primary outcome is recovery assessed with the Post-operative Quality of Recovery Scale (PQRS) at postoperative day 1. Secondary outcomes include PQRS score in the post anaesthesia care unit and at postoperative day 3, postoperative complications until postoperative day 28, hospital length of stay and process-related outcomes.DiscussionThe IPPCollapse-II study will be the first randomised clinical study that assesses the impact of an individualised pneumoperitoneum pressure strategy focused on working with the lowest intra-abdominal pressure during colorectal laparoscopic surgery on relevant patient-centred outcomes. The results of this large study, to be disseminated through conference presentations and publications in international peer-reviewed journals, are of ultimate importance for optimising the care and safety of laparoscopic abdominal surgery. Selection of patient-reported outcomes as the primary outcome of this study facilitates the translation into clinical practice. Access to source data will be made available through anonymised datasets upon request and after agreement of the Steering Committee of the IPPCollapse-II study.Trial registrationClinicalTrials.gov, NCT02773173 . Registered on 16 May 2016. EudraCT, 2016-001693-15. Registered on 8 August 2016.

Project description:Objective: To evaluate the safety and oncological outcomes of laparoscopic colorectal surgery using natural orifice specimen extraction (NOSE) compared with conventional laparoscopic (CL) colorectal surgery in patients with colorectal diseases. Methods: We conducted a systematic search of PubMed, EMBASE, and Cochrane databases for randomized controlled trials (RCTs), prospective non-randomized trials and retrospective trials up to September 1, 2018, and used 5-year disease-free survival (DFS), lymph node harvest, surgical site infection (SSI), anastomotic leakage, and intra-abdominal abscess as the main endpoints. Subgroup analyses were conducted according to the different study types [RCT and NRCT (non-randomized controlled trial)]. A sensitivity analysis was carried out to evaluate the reliability of the outcomes. RevMan5.3 software was used for statistical analysis. Results: Fourteen studies were included (two RCTs, seven retrospective trials and five prospective non-randomized trials) involving a total of 1,435 patients. Compared with CL surgery, the NOSE technique resulted in a shorter hospital stay, shorter time to first flatus, less post-operative pain, and fewer SSIs and total perioperative complications. Anastomotic leakage, blood loss, and intra-abdominal abscess did not differ between the two groups, while operation time was longer in the NOSE group. Oncological outcomes such as proximal margin [weighted mean difference [WMD] = 0.47; 95% confidence interval [CI] -0.49 to 1.42; P = 0.34], distal margin (WMD= -0.11; 95% CI -0.66 to 0.45; P = 0.70), lymph node harvest (WMD = -0.97; 95% CI -1.97 to 0.03; P = 0.06) and 5-year DFS (hazard ratio = 0.84; 95% CI 0.54-1.31; P = 0.45) were not different between the NOSE and CL surgery groups. Conclusions: Compared with CL surgery, NOSE may be a safe procedure, and can achieve similar oncological outcomes. Large multicenter RCTs are needed to provide high-level, evidence-based results in NOSE-treated patients and to determine the risk of local recurrence.

Project description:Fast-track surgery (FTS), a multimodal rehabilitation technique, has been recommended as surgical therapy for colorectal cancer. The objective of the present study was to compare the outcomes of FTS and conventional laparoscopic surgery. This study was a blinded randomized trial. A total of 70 patients with colorectal cancer were divided into two groups and underwent laparoscopic colorectal resection. The FTS group consisted of 31 patients and the control group consisted of 39 patients. Protocols for the treatment of the FTS group included skipping pre-operative mechanical bowel preparation, early restoration of diet and early post-operative ambulation. Outcome measures, length of hospital stay, post-operative surgical stress response [C-reactive protein (CRP)] and post-operative complications were compared between the two groups. The average length of total hospital stay for the FTS and the control groups was 5.9±0.8 and 10.9±1.3 days, respectively (P<0.05), and the length of post-operative hospital stay for the FTS and control group was 4.3±0.8 and 8.0±1.1 days, respectively. (P<0.05) First flatus time for the FTS and control groups was 1.6±0.8 and 2.5±0.9 days, respectively (P<0.05). Defecation time for the FTS and control groups was 2.2±0.7 and 4.5±0.7 days, respectively (P<0.05). The time to restoration of a solid diet also showed a significant difference between the FTS and control groups (1.1±0.3 vs. 3.6±0.9 days; P<0.05). Following surgery, due to post-operative surgical stress, the two groups CRP levels increased significantly, but the levels of the FTS group were lower than those of the conventional control group (P<0.05). There was no difference in post-operative complications between the FTS and control groups. This study confirms that FTS shortens hospital stay and accelerates the recovery of bowel function without increase of post-operative complications. FTS is safe, improves post-operative recovery and is a better option than conventional laparoscopic surgery for treating colorectal cancer patients.

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A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

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A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

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