The British journal of surgery
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Randomized Controlled Trial Multicenter Study
Long-term follow-up of the randomized trial of mesorectal excision with or without lateral lymph node dissection in rectal cancer (JCOG0212).
Japan Clinical Oncology Group (JCOG) 0212 (ClinicalTrials.gov NCT00190541) was a non-inferiority phase III trial of patients with clinical stage II-III rectal cancer without lateral pelvic lymph node enlargement. The trial compared mesorectal excision (ME) with ME and lateral lymph node dissection (LLND), with a primary endpoint of recurrence-free survival (RFS). The planned primary analysis at 5 years failed to confirm the non-inferiority of ME alone compared with ME and LLND. The present study aimed to compare ME alone and ME with LLND using long-term follow-up data from JCOG0212. ⋯ Long-term follow-up data did not support the non-inferiority of ME alone compared with ME and LLND. ME with LLND is recommended for patients with clinical stage III disease, whereas LLND could be omitted in those with clinical stage II tumours.
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Randomized Controlled Trial
Telemedicine in postoperative follow-up of STOMa PAtients: a randomized clinical trial (the STOMPA trial).
A stoma has severe impact on the patient's quality of life (QoL). Postoperative home community follow-up by teleconsultation (TC) and stoma nurses may reduce the burden of travel and improve QoL. ⋯ Telemedicine follow-up by stoma nurses did not improve the QoL of patients, but decreased the readmission rate and burden of travel. Registration number NCT01600508 ( https://www.clinicaltrials.gov).
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Randomized Controlled Trial
Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial.
Supervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof-of-concept study and RCT were conducted. ⋯ Footplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an adjunct to supervised exercise. Registration number: trial 1, NCT02436200; trial 2, NCT02429310 (http://www.clinicaltrials.gov).
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Randomized Controlled Trial Comparative Study
Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial).
Several non-randomized and retrospective studies have suggested that intracorporeal anastomosis (IA) has advantages over extracorporeal anastomosis (EA) in laparoscopic right colectomy, but scientific evidence is lacking. The aim was to compare short-term outcomes and to define the possible benefits of IA compared with EA in elective laparoscopic right colectomy. ⋯ Duration of hospital stay was similar, but IA was associated with less pain and fewer complications. Registration number: NCT02667860 ( http://www.clinicaltrials.gov).
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Randomized Controlled Trial Multicenter Study
Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial.
The objective of the study was to analyse patient-reported outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain after closure of the fascial defect in patients undergoing laparoscopic umbilical hernia mesh repair. ⋯ Closure of the fascial defect in laparoscopic umbilical hernia IPOM repair significantly reduced early seroma formation and long-term recurrence without inducing side-effects such as pain, or other early or late PROMs. Registration number: NCT01962480 ( https://www.clinicaltrials.gov).