Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Multi-Port vs. Single-port Cholecystectomy
Brief Summary: The aim of this study is to compare results of the new surgical strategy to the traditional 4-ports technique for cholecystectomy in a randomized controlled trial (RCT). In particular we are going to investigate the procedures in terms of overall morbidity, while taking into considerations skin-incision's related morbidity, postoperative pain and cosmetic results which are the hypothetical benefits of the new approach. Other parameters are supposed to be unchanged, considering evidences from recent literature.

Surgical procedures:

4 ports cholecystectomy (4PC): a 12mmHg pneumoperitoeum is created either by a 10mm umbilical Hasson's port or by a Verress needle followed by a 10mm umbilical port insertion; further one 10mm and two 5mm ports are placed according to the preferred technique.

Single Port Access cholecystectomy (SPC): the single-port device is inserted through the umbilicus, by means of an adeguate incision, as the only access to the abdominal cavity. A trans-abdominal suture in right hypochondrium is placed through the gallbladder wall of the fundus to retract it.

Primary endpoint: overall morbidity rate (at 60 days from surgery)

Secondary endpoints:

1. skin-incision's related morbidity rate (at 60 days from surgery)
2. perioperative pain
3. cosmetic results
4. long-term morbidity (12 months)
5. intraoperative time
6. "conversion SPC to 4PC" rate
7. "conversion to laparotomy" rate
8. hospital stay


Options:
A: Arm Label: Multi port; Type: ACTIVE_COMPARATOR; Interventions: Procedure: 4-Ports Cholecystectomy (4PC) | Arm Label: Single port; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Single-Port Cholecystectomy (SPC) | Intervention Type: PROCEDURE; Name: 4-Ports Cholecystectomy (4PC); Assigned to Arm(s): Multi port | Intervention Type: PROCEDURE; Name: Single-Port Cholecystectomy (SPC); Assigned to Arm(s): Single port
B: Arm Label: Laparoscopy; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Cholecystectomy | Arm Label: Transumbilical; Type: EXPERIMENTAL; Interventions: Procedure: Cholecystectomy | Arm Label: Transvaginal; Type: EXPERIMENTAL; Interventions: Procedure: Transvaginal hybrid NOTES cholecystectomy, Procedure: Cholecystectomy | Intervention Type: PROCEDURE; Name: Transvaginal hybrid NOTES cholecystectomy; Assigned to Arm(s): Transvaginal | Intervention Type: PROCEDURE; Name: Cholecystectomy; Assigned to Arm(s): Laparoscopy, Transumbilical, Transvaginal
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Device: Laparoscopic cholecystectomy surgery | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Device: Laparoscopic cholecystectomy surgery | Intervention Type: DEVICE; Name: Laparoscopic cholecystectomy surgery; Assigned to Arm(s): 1, 2
D: Arm Label: LESS cholecystectomy; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Cholecystectomy | Arm Label: Standard LAP-CHOLE; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Cholecystectomy | Arm Label: LESS Cholecystectomy not blind; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Cholecystectomy | Intervention Type: PROCEDURE; Name: Cholecystectomy; Assigned to Arm(s): LESS Cholecystectomy not blind, LESS cholecystectomy, Standard LAP-CHOLE

Answer: A