Multicentre Prospective randomized trial of laparoscopic Radical resection of colorectal cancer with or without natural orifice specimen extraction
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ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 2699393 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Interventions: single arm:NOSES Method
Primary outcome(s): Periprocedural complications
Study Design: Single arm
| 2686503 | ecrin-mdr-crc
Project description:Minimally invasive colorectal surgery is currently well-accepted, with open techniques being reserved for very difficult cases. Laparoscopic colectomy has been proven to have lower mortality, complication, and ostomy rates; a shorter median length of stay; and lower overall costs when compared to its open counterpart. This trend is seen in both benign and malignant indications. Natural orifice specimen extraction surgery (NOSES) in colorectal surgery was first described in the early 1990s. Three recent meta-analyses comparing transabdominal extraction against NOSES concluded that NOSES was superior in terms of overall postoperative complications, recovery of gastrointestinal function, postoperative pain, aesthetics, and hospital stay. However, NOSES was associated with a longer operative time. Herein, we present our technique of robotic NOSES anterior resection using the da Vinci Xi platform in diverticular disease and sigmoid colon cancers.
| S-EPMC10781600 | biostudies-literature
Project description:Interventions: NOSES:NOSES;Laparoscopy group:Laparoscopy
Primary outcome(s): peritoneal lavage cytology;microbiology
Study Design: Parallel
| 2687707 | ecrin-mdr-crc
Project description:The goal of this type of study: a prospective, randomized controlled clinical trial is to assess the safety and feasibility of NOSE surgery to compare the NOSE and conventional laparoscopy groups in Colorectal cancer patients. The main questions it aims to answer are measuring the postoperative inflammatory response and monitoring the early morbidity and mortality rate after surgery. Participants will be assigned patients to undergo either NOSE surgery or conventional laparoscopic mini-laparotomy resection. If there is a comparison group: Researchers will compare the control group to see if postoperative inflammatory response.
| 9277 | ecrin-mdr-crc
Project description:In recent years, natural orifice specimen extraction surgery (NOSES) in the treatment of colorectal cancer has attracted widespread attention. The potential benefits of NOSES including reduction in postoperative pain and wound complications, less use of postoperative analgesic, faster recovery of bowel function, shorter length of hospital stay, better cosmetic and psychological effect have been described in colorectal surgery. Despite significant decrease in surgical trauma of NOSES have been observed, the potential pitfalls of this technique have been demonstrated. Particularly, several issues including bacteriological concerns, oncological outcomes and patient selection are raised with this new technique. Therefore, it is urgent and necessary to reach a consensus as an industry guideline to standardize the implementation of NOSES in colorectal surgery. After three rounds of discussion by all members of the International Alliance of NOSES, the consensus is finally completed, which is also of great significance to the long-term progress of NOSES worldwide.
| S-EPMC6375350 | biostudies-literature
Project description:One of the major criticisms of laparoscopic colectomy is the requirement of an additional mini laparotomy to remove the resected specimen. This may be associated with postoperative pain and wound complications. Therefore, the use of a natural orifice as a delivery route for the specimen extraction without a laparotomy incision can subsequently reduce the risk of wound complications. In this video, we demonstrate the natural orifice specimen extraction procedure with a side-to-end single-stapling colorectal anastomosis.
| S-EPMC8985621 | biostudies-literature
Project description: Not available
| S-EPMC9610632 | biostudies-literature
Project description:BackgroundThis study aimed to evaluate cosmetic outcomes and feasibility of transvaginal natural orifice specimen extraction (NOSE) in patients who underwent laparoscopic or robotic surgery for the treatment of benign or malignant diseases of the kidney, liver, stomach, adrenal gland, and bladder.MethodsThis prospective study was conducted at a tertiary hospital between March 2015 and May 2020. The main outcome was cosmetic outcomes of scars assessed using the Patient and Observer Scar Assessment Scale (POSAS) 1 and 8 weeks after surgery. The secondary outcomes were postoperative pain, operating time, and complications. Sexual function was assessed using the Female Sexual Function Index (FSFI) questionnaire 6 months after surgery in 17 patients who were sexually active at the time of surgery.ResultsA total of 38 transvaginal NOSE procedures were performed for the extraction of 33 kidneys, 2 livers, 1 stomach, 1 adrenal gland, and 1 bladder. Observers rated pigmentation and relief scores as most deviant from normal skin (2.9 ± 1.7, 3.0 ± 2.1 at postoperative 1 week; 3.6 ± 1.9, 3.5 ± 2.2 at postoperative 8 weeks, respectively), but the overall scores of each item were low. The patients' overall satisfaction with postoperative scars was high, and the mean scores for pain and itching were low, with significant improvement from the first week to the eighth week (P = 0.014 and P = 0.006, respectively). Patients also reported low scores on vaginal assessment items, indicating better symptoms, and bleeding improved significantly between the two time points (P = 0.001). Postoperative pain was reduced from moderate during the first 24 h after surgery to mild after 24 h. The mean operative time of the transvaginal NOSE procedure was 28.3 ± 13.3 min. No postoperative complications were associated with the procedure. The mean FSFI total score was 21.2 ± 8.7 (cutoff score for dysfunction is 21), with higher scores indicating better sexual functioning.ConclusionTransvaginal NOSE seems to be a feasible procedure with promising cosmetic benefits, for patients who undergo minimally invasive surgery for large organs including the kidney, liver, stomach, adrenal gland, and bladder. A prospective randomized clinical trial is needed to provide solid evidence to support transvaginal NOSE.Trial registrationThis trial is registered at ClinicalTrials.gov (NCT05113134).
| S-EPMC9617319 | biostudies-literature
Project description:BackgroundNatural orifice specimen extraction (NOSE) is a technique that involves collecting a specimen for extraction through a natural opening avoiding a mini-laparotomy incision. The aim of this study was to compare NOSE and transabdominal specimen extraction in laparoscopic (LAP) colorectal cancer surgery for postoperative outcomes and oncological safety.MethodA systematic search was conducted in five electronic databases from inception till October 2020. Articles were selected based on the inclusion criteria (studies comparing LAP and NOSE colorectal surgeries reporting at least one of the outcomes) and analysed. Primary outcomes included postoperative complications, pathological results (resection margins and lymph node collection), and oncological outcomes. Secondary outcomes included operating time, blood losses, use of analgesics, functional recovery, duration of hospital stay, and cosmetic results. Fixed and random-effect models were used to measure the pooled estimates.ResultsNineteen studies involving a total of 3432 participants were analysed (3 randomized clinical trials (RCTs) and 16 retrospective non-randomized studies). Pooled results showed significantly reduced postoperative complications (OR 0.54; 95 per cent c.i. 0.44 to 0.67; P < 0.00001). Pathological outcomes of NOSE were comparable to LAP with no significant difference noted in terms of resection margins (P > 0.05) and lymph node collection (weighted mean difference (WMD) -0.47; 95 per cent c.i. -0.94 to 0; P = 0.05). Pooled analysis demonstrated comparable long-term outcomes in terms of cancer recurrence (OR 0.94; 95 per cent c.i. 0.63 to 1.39; P = 0.75), 5-year disease-free survival (HR 0.97; 95 per cent c.i. 0.73 to 1.29; P = 0.83), and overall survival (HR 0.93, 95 per cent c.i. 0.58 to -1.51; P = 0.78). Finally, the NOSE group had decreased use of additional analgesia after surgery and earlier resumption of oral intake when compared with LAP (respectively OR 0.28; 95 per cent c.i. 0.20 to 0.37; P < 0.00001 and WMD -0.35; 95 per cent c.i. -0.54 to -0.15; P = 0.0005).ConclusionThis meta-analysis showed that in comparison with LAP, NOSE decreases severe postoperative morbidity while improving postoperative recovery without compromising oncological safety, but it is limited by the small number of RCTs performed in this field.
| S-EPMC9155237 | biostudies-literature
Project description:BackgroundNatural orifice specimen extraction surgery is a novel technique of minimally invasive surgery. The purpose of this study was to compare the safety of laparoscopic anterior resection with natural orifice specimen extraction (NOSE-LAR) and abdominal incision specimen extraction (AISE-LAR) for sigmoid or rectum tumors.MethodsMEDLINE (PubMed), Embase, CENTRAL (Cochrane Central Register of Controlled Trials), Scopus, and ClinicalTrials databases were systematically searched for related articles up to August 2019. The primary outcomes included postoperative complications (overall postoperative complication, incision-related complication, anastomotic fistula, and severe complication) and pathologic results (lymph nodes harvested, proximal resection margin, and distal resection edge). The statistical analysis was performed on STATA 12.0 software.ResultsTen studies comprising 1787 patients were used for meta-analysis. Compared with AISE-LAR, NOSE-LAR had more advantages in terms of overall postoperative complication (odds ratio (OR) = 0.65 (95% CI, 0.46 to 0.90; P = 0.01)), incision-related complication (OR = 0.13 (95% CI, 0.05 to 0.35; P < 0.01)), distal resection edge (weighted mean difference (WMD) = 0.17 cm (95% CI, 0.02 to 0.33 cm; P = 0.02)), recovery of gastrointestinal function (WMD = - 0.38 day (95% CI, - 0.70 to - 0.06 day; P = 0.02 )), pain scores in postoperative day 1 (WMD = - 1.64 (95% CI, - 2.31 to - 0.98; P < 0.01)), additional analgesics usage (OR = 0.21 (95% CI, 0.11 to 0.40; P < 0.01)) and hospital stay (WMD = - 0.71 day (95% CI, - 1.10 to - 0.32 day; P < 0.01)), while the operation time of NOSE-LAR was prolonged (WMD = 7.4 min (95% CI, 0.17 to 14.64 min; P = 0.04)). The anastomotic fistula, severe complication, lymph nodes harvested, proximal resection margin, intraoperative blood loss, and long-term outcomes in NOSE-LAR were comparable with AISE-LAR.ConclusionsThe safety of NOSE-LAR was demonstrated, and it could be an alternative to conventional surgery in laparoscopic anterior resection for sigmoid and rectal tumors. However, further randomized and multi-center trials are required.
| S-EPMC7439723 | biostudies-literature