Evaluation of Dual Dye Technique for Sentinel Lymph Node Biopsy in Breast Cancer: Two-Arm Open-Label Parallel Design Non-Inferiority Randomized Controlled Trial.

INTRODUCTION: Radioisotope and blue dye are standard agents for performing sentinel lymph node (SLN) biopsy in breast cancer. The paucity of nuclear medicine facility poses logistic challenge. This study evaluated performance of radioisotope & methylene blue (MB) with indocyanine green (ICG) and MB for SLNB. PATIENTS AND METHODS: This randomized controlled trial was conducted from December 2019 to July 2022 comparing SLN identification proportions of radioisotope-blue dye [Group A] with dual dye (MB + ICG; Group B]. Secondary objective included time required and cost effectiveness of performing SLNB. Sample size of 70 (35 in each arm) was calculated. Upfront operable node negative early breast cancer was included in the study. Clinico-demographic data, number & type of SLN, time taken were noted. Cost analysis was done including the equipment, manpower & consumables. Chi-square/Fisher exact test was used to compare proportion between two groups. p value of less than 0.05 was considered to represent statistical significance. RESULTS: Seventy patients randomized to either group were similar in clinico-demographic and tumor characteristics. SLN identification rate (IR) was 91.43% in group A and 100% in group B. Overall IR of MB, radioisotope and ICG were 91.43%, 91.43% and 100%, respectively. Mean number of SLNs identified were 3 in group A and 4 in group B. Median time required for SLNB was 12 min and 14 min in either group, respectively. Cost of performing SLNB was higher in Group B. CONCLUSION: SLNB using dual dye is non-inferior to radioisotope-blue dye in upfront operable early breast cancer. Trial registration number Clinical Trial registry India CTRI/2020/02/023503.

Radiology of anal and lower rectal cancers.

Lower rectal and anal cancers are distinct from neoplasms involving rest of the rectum. These are relatively difficult to manage owing to important relationships with the sphincter muscles. Involvement of the latter portends a poorer prognosis and increased chance of recurrence. Lymphatic drainage of these tumours is into the systemic circulation and the exact set of lymph nodes involved depends on the precise location of the tumour. The role of imaging includes assessment of local invasion, infiltration of adjacent pelvic organs, assessment of locoregional lymphatic spread and metastasis, post-chemoradiation restaging as well as post-treatment surveillance.

Experimental trial of transvaginal cholecystectomy: an ex vivo analysis of the learning process for a novel single-port technique.

BACKGROUND: Interest in natural orifice transluminal endoscopic surgery (NOTES) has expanded, and the first experiences with patients using different techniques have been reported. However, no work has addressed the learning process or the limitations of the procedures. The relation between inexperience and complications became a major concern after the introduction of laparoscopic surgery. This study investigates the learning process for a new technique using specially designed instruments in an ex vivo model before clinical application. METHODS: Specially designed instruments and a single-port technique using the Tuebingen Trainer were used to evaluate instrument and surgeon performance (learning curve) in terms of time and errors. A total of 90 procedures performed by three surgeons were evaluated. Group and individual learning curves were plotted. RESULTS: All the surgeons showed a reduction in both mean cholecystectomy time (subject A: 27.2 vs 16.6 min; subject B: 21.4 vs 19.22 min; subject C: 21 vs 19.7 min) and mean errors (subject A: 2.8 vs 1.6; subject B: 3.5 vs 2.6; subject C: 3.5 vs 2). A plateau was reached after approximately 15 procedures. Group learning curve analysis showed a significant reduction in time between the first group (mean, 24.97 +/- 5.8 min) and last group (mean, 19.30 +/- 3.09 min; F[1,28] = 11.83; p = 0.001) for 15 procedures, as well as reduced technical errors in the fifth group, from 3.7 +/- 1.65 to 1.6 +/- 1.04 (F[1,28] = 8.90; p < 0.01), demonstrating a learning effect. The number of optic and access port position changes were recorded, setting a standard for normal instrument performance. CONCLUSION: This study shows that the tasks of cholecystectomy can be learned safely in a reasonable number of simulations with the new instruments. Although this is a new technique, prior laparoscopic surgery experience is helpful. The technique offers an advantage over those using flexible endoscopes.

Total extra-peritoneal repair of groin hernia: prospective evaluation at a tertiary care center.

BACKGROUND: The laparoscopic repair of groin hernia is increasingly being used. However, the relative merits and demerits of laparoscopic repair are debatable. The present study was undertaken to evaluate the total extra-peritoneal (TEP) repair of groin hernia. METHODS: This prospective study was undertaken at a single surgical unit between January 2004 and June 2006. Consecutive patients with elective groin hernias were offered laparoscopic TEP repair. Indigenous balloon or telescopic dissection was used to create extra-peritoneal space. Polypropylene mesh was used in all of the patients and mesh fixation was performed with tackers. RESULTS: A total of 185 patients with age range 18-92 years were included; 180 were males. TEP repair was attempted in 298 groin hernias in 185 patients with a success rate of 89.5%. Indigenous balloon or telescopic dissection was used to create extra-peritoneal space. Thirty-one (31, 10.5%) TEP repairs were converted to transabdominal pre-peritoneal or open repair. Two patients developed recurrence during follow-up. CONCLUSION: TEP is an excellent technique for laparoscopic groin hernia repair, with acceptable rates of complication.