Multicenter Randomized Controlled Trial of Conventional Versus Laparoscopic Surgery for Colorectal Cancer Within an Enhanced Recovery Programme: EnROL

2014 ◽  
Vol 32 (17) ◽  
pp. 1804-1811 ◽  
Author(s):  
Robin H. Kennedy ◽  
E. Anne Francis ◽  
Rose Wharton ◽  
Jane M. Blazeby ◽  
Philip Quirke ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Laparoscopic Surgery ◽  
Hospital Stay ◽  
Open Surgery ◽  
Enhanced Recovery ◽  
Controlled Trial ◽  
Physical Fatigue ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Secondary Outcomes

Purpose Laparoscopic resection and a multimodal approach known as an enhanced recovery program (ERP) have been major changes in colorectal perioperative care that have improved clinical outcomes for colorectal cancer resection. EnROL (Enhanced Recovery Open Versus Laparoscopic) is a multicenter randomized controlled trial examining whether the benefits of laparoscopy still exist when open surgery is optimized within an ERP. Patients and Methods Adults with colorectal cancer suitable for elective resection were randomly assigned at a ratio of 1:1 to laparoscopic or open surgery within an ERP, stratified by center, cancer site (colon v rectum), and age group (< 66 v 66-75 v > 75 years) using minimization. The primary outcome was physical fatigue at 1 month postsurgery. Secondary outcomes included hospital stay, complications, other patient-reported outcomes (PROs), and physical function. Patients and outcome assessors were blinded until 7 days postsurgery or discharge if earlier. Central independent and blinded pathologic assessment of surgical quality was undertaken. Results A total of 204 patients (laparoscopy, n = 103; open surgery, n = 101) were recruited from 12 UK centers from July 2008 to April 2012. One-month physical fatigue scores were similar in both groups (mean: laparoscopy, 12.28; 95% CI, 11.37 to 13.19 v open surgery, 12.05; 95% CI, 11.14 to 12.96; adjusted mean difference, −0.23; 95% CI, −1.52 to 1.07). Median total hospital stay was significantly shorter after laparoscopic surgery (median: laparoscopy, 5; interquartile range [IQR], 4 to 9 v open surgery, 7; IQR, 5 to 11 days; P = .033). There were no differences in other secondary outcomes or in specimen quality after central pathologic review. Conclusion In patients treated by experienced surgeons within an ERP, physical fatigue and other PROs were similar in both groups, but laparoscopic surgery significantly reduced length of hospital stay.

scholarly journals Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rui Luo ◽  
Fangfang Zheng ◽  
Haobo Zhang ◽  
Weiquan Zhu ◽  
Penghui He ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Natural Orifice ◽  
Specimen Extraction ◽  
Natural Orifice Specimen Extraction ◽  
Robotic Assisted ◽  
Randomized Controlled ◽  
Robotic Assisted Surgery ◽  
Secondary Outcomes

Abstract Background Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes. Method/design Accordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system. Discussion This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes. Trial registration ClinicalTrials.govNCT04230772. Registered on January 15, 2020.

scholarly journals Implementation of enhanced recovery after surgery in gynecological operations: a randomized controlled trial

2020 ◽  
Vol 12 (1) ◽  
Author(s):  
Amr Nady Abdelrazik ◽  
Ahmad Sameer Sanad
Keyword(s):  
Hospital Stay ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Gynecologic Surgery ◽  
Complication Rates ◽  
Control Groups ◽  
Analog Scale ◽  
Randomized Controlled

Abstract Background To investigate the effects of enhanced recovery after surgery (ERAS) in patients undergoing gynecologic surgery on length of hospital stay, pain management, and complication rate. Results The length of hospital stay was reduced in ERAS groups when compared with the control groups (3.46 days vs 2.28 days; P < 0.0001; CI − 1.5767 to − 0.7833 for laparotomy groups and 2.18 vs 1.76 days; P = 0.0115; CI − 0.7439 to − 0.0961 for laparoscopy groups respectively). Intraoperative fluid use was reduced in both ERAS groups compared to the two control groups (934 ± 245 ml and 832 ± 197 ml vs 1747 ± 257 ml and 1459 ± 304 respectively; P < 0.0001) and postoperative fluid use was also less in the ERAS groups compared to the control groups (1606 ± 607 ml and 1210 ± 324 ml vs 2682 ± 396 ml and 1469 ± 315 ml respectively; P < 0.0001). Pain score using visual analog scale (VAS) on postoperative day 0 was 4.8 ± 1.4 and 4.1 ± 1.2 (P = 0.0066) for both laparotomy control and ERAS groups respectively, while in the laparoscopy groups, VAS was 3.8 ± 1.1 and 3.2 ± 0.9 (P = 0.0024) in control and ERAS groups respectively. Conclusion Implementation of ERAS protocols in gynecologic surgery was associated with significant reduction in length of hospital stay, associated with decrease intravenous fluids used and comparable pain control without increase in complication rates.

scholarly journals “Enhanced recovery after surgery – ERAS in elective craniotomies-a non-randomized controlled trial”

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Anirudh Elayat ◽  
Sritam S. Jena ◽  
Sukdev Nayak ◽  
R. N. Sahu ◽  
Swagata Tripathy
Keyword(s):  
Randomized Controlled Trial ◽  
Glycemic Control ◽  
Hospital Stay ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Controlled Trial ◽  
Early Recovery ◽  
Randomized Controlled ◽  
Pain Scores ◽  
High Dependency

Abstract Background Enhanced Recovery After Surgery (ERAS) is a multimodal perioperative care bundle aimed at the early recovery of patients. Well accepted in gastric and pelvic surgeries, there is minimal evidence in neurosurgery and neurocritical care barring spinal surgeries. We wished to compare the length of intensive care unit (ICU) or high dependency unit (HDU) stay of patients undergoing elective craniotomy for supratentorial neurosurgery: ERAS protocol versus routine care. The secondary objective was to compare the postoperative pain scores, opioid use, glycemic control, and the duration of postoperative hospital stay between the two groups. Methods In this pragmatic non-randomized controlled trial (CTRI/2017/07/015451), consenting adult patients scheduled for elective supratentorial intracranial tumor excision were enrolled prospectively after institutional ethical clearance and consent. Elements-of-care in the ERAS group were- Preoperative –family education, complex-carbohydrate drink, flupiritine; Intraoperative – scalp blocks, limited opioids, rigorous fluid and temperature regulation; Postoperative- flupiritine, early mobilization, removal of catheters, and initiation of feeds. Apart from these, all perioperative protocols and management strategies were similar between groups. The two groups were compared with regards to the length of ICU stay, pain scores in ICU, opioid requirement, glycemic control, and hospital stay duration. The decision for discharge from ICU and hospital, data collection, and analysis was by independent assessors blind to the patient group. Results Seventy patients were enrolled. Baseline demographics – age, sex, tumor volume, and comorbidities were comparable between the groups. The proportion of patients staying in the ICU for less than 48 h after surgery, the cumulative insulin requirement, and the episodes of VAS scores > 4 in the first 48 h after surgery was significantly less in the ERAS group – 40.6% vs. 65.7%, 0.6 (±2.5) units vs. 3.6 (±8.1) units, and one vs. ten episodes (p = 0.04, 0.001, 0.004 respectively). The total hospital stay was similar in both groups. Conclusion The study demonstrated a significant reduction in the proportion of patients requiring ICU/ HDU stay > 48 h. Better pain and glycemic control in the postoperative period may have contributed to a decreased stay. More extensive randomized studies may be designed to confirm these results. Trial registration Clinical Trial Registry of India (CTRI/2018/04/013247), registered retrospectively on April 2018.

Fast track multidiscipline treatment versus conventional treatment for colorectal cancer: The results of a prospective randomized controlled study (FTMDT trial).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 743-743
Author(s):  
Ke-Feng Ding ◽  
Jun Li ◽  
Jiao-Jiao Zhou ◽  
Xiang-Xing Kong ◽  
Jin-Jie He ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Laparoscopic Surgery ◽  
Adverse Events ◽  
Open Surgery ◽  
Conventional Treatment ◽  
Fast Track ◽  
Total Hospital ◽  
Perioperative Treatment ◽  
Randomized Controlled ◽  
Hospital Stays

743 Background: Fast Track Multi-Discipline Treatment (FTMDT) integrates fast-track perioperative treatment (laparoscopic or open surgery) plus XELOX adjuvant chemotherapy for colorectal cancer (CRC). This study aimed to verify the effects of FTMDT model and to clarify the value of laparoscopic surgery in fast-track perioperative treatment. Methods: The study (NCT01080547) was a prospective randomized controlled multi-centers study. Group I (FTMDT) received fast-track treatment plus XELOX chemotherapy (Group Ia received laparoscopic surgery and Group Ib received open surgery). Group II (conventional treatment, CT) received conventional treatment plus mFOLFOX6 chemotherapy (Group IIa received laparoscopic surgery and Group IIb received open surgery). The primary endpoint was total hospital stays during treatment. The secondary endpoints included surgical complications, chemotherapy related adverse events, quality of life and hospitalization costs. Results: Between April 2010 and June 2014, 374 patients were enrolled and 342 patients were finally analyzed. The total hospital stays were shorter in FTMDT than CT (median 13 days vs. 23.5 days, P= 0.0001) but similar between Group Ia and Group Ib (median 13 days vs. 14 days, P= 0.1951). The postoperative hospital stays were shorter in FTMDT than CT (median 6 days vs. 9 days, P= 0.0001) but similar between Group Ia and Group Ib (median 6 days vs. 6 days, P= 0.2160). Resume of flatus and defecation was earlier in FTMDT ( P< 0.05) and Group Ia was the earliest. The in-hospital complication rate was lower in FTMDT (6.40% vs. 14.71%, P= 0.014) but similar between Group Ia and Group Ib. The surgery cost of Group Ib was the lowest ( P< 0.05). The rate of chemotherapy related adverse events was similar between FTMDT and CT( P> 0.05). The EORTC QLQ-C30 physical functioning and fatigue in one week postoperative were better in FTMDT than CT( P< 0.05). Conclusions: FTMDT model enhanced the postoperative recovery of CRC patients. On the premise of fast-track perioperative treatment, laparoscopic surgery showed minor advantage over open surgery which had economic advantages. Clinical trial information: NCT01080547.

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