Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: protocol for a randomized controlled trial

Table 1 Study outline

Schedule	Enrollment	Surgery	Inpatient assessment	1st Outpatient follow-up	2nd Outpatient follow-up^c
Assessment No.	1	2	3	4	5
Time	–6 weeks to 0	0	up to 1 week^b	1mo^b	1 year
Informed consent	x
Medical history	x
In-/exclusion criteria	x
Physical examination	x		x	x	(x) ^c
Registration	x
Imaging^a	x
Randomization	x
Questionnaire 1: LED (surgeon)		x
Questionnaire :2 SMEQ (surgeon)		x
Duration of surgery		x
Intraoperative blood loss		x
Intraoperative conversion		x
Evaluation of complications			x	x	x
Length of hospital stay			x
Costs of procedure			x
Questionnaire 3: HR-QoL (patient)	x			x	x
Questionnaire 4: Cosmesis (patient)				x	x

Each x signifies one test, report, or procedure
^aUSS and/or CT and/or MRI abdomen
^bIn case of AE, inpatient assessment and/or outpatient FU-visit might exceed the given time limit; All patients will be assessed until the day of discharge and 3–4 weeks after surgery
^cThe 2nd postoperative follow-up of the patient may either be done in the outpatient clinic or the assessement may be conducted by phone. In case the patient is seen in the outpatient clinic, the insurance company of the participant will not be charged by the hospital

ISSN: 1471-2482