Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial).

BACKGROUND: Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC). METHODS: This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727). RESULTS: The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P < 0.001]. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (P = 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups. CONCLUSIONS: In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC.

Rural surgery in southern Sudan.

INTRODUCTION: This article reports a retrospective analysis of a 6-year experience of providing surgical care in remote areas of southern Sudan under extremely adverse conditions. METHODS: Teams of expatriate consultants (surgeon, anesthetist, scrub nurse) carried out 28 "surgical missions" with the aims of treating surgical cases previously selected and of training local personnel in basic surgery on the job. RESULTS: A total of 1642 patients (71% males, 30% under the age of 16) have undergone an operation. Altogether, 1264 elective procedures (77%) and 378 emergency procedures (23%) were performed. Hernia surgery comprised the main workload, followed by proctologic and gynecologic operations. Most operations were performed under spinal anesthesia. Other cases required ketamine, and a small number of patients had local anesthesia. There were 14 fatal complications, most of them related to the delay in obtaining medical attention. Based on the training results, the Sudanese personnel of two of the five health centers involved in the program are already fully autonomous. Two doctors and two nurses are proficient in essential surgery; two not qualified nurses are proficient in "primary" anesthesia; and others are proficient in scrubbing and surgical nursing. CONCLUSIONS: This report demonstrates that it is feasible to establish surgical services in rural areas of developing countries by utilizing simple facilities, providing them with basic equipment, and employing local personnel selected and trained on the job by teams composed of a consultant surgeon, anesthetist, and scrub nurse. This seems to be the only realistic possibility for providing surgical care to the rural populations of the least developed countries.