Chopstick technique versus cross technique in LESS hysterectomy (CCLEH study): a prospective randomized controlled trial

Table 2 Patient’s characteristics and data collection

Timepoint	Study period
	Enrollment	Allocation	Post-allocation					Close-out
	Enrollment	0	Pre-operation	Operation	Post-operation	Discharge	After 8 weeks	Close-out
Enrollment
Eligibility screen	X
Informed consent	X
Allocation		X
Interventions
Chopsticks technique				X
Cross technique				X
Assessments
Baseline characteristics			X
Total operation time^a				X
Single-port establishment time^b				X				X
Pelvic-abdominal adhesion release time^c				X				X
Total hysterectomy time^d				X				X
Specimen removal time^e				X				X
Stump suture time^f				X				X
Conversion to another LESS technique				X				X
Conversion to traditional laparoscopy /laparotomy				X
Estimated blood loss^f				X	X			X
Intraoperative complications				X	X			X
Surgeon fatigue (FSS)^h					X			X
Post-operative hospital stay						X		X
Hospitalization expenses						X		X
Post-operative hospital stay						X
Postoperative complicationsⁱ							X	X
Health-related quality of life (EQ-5D)			X				X	X

^a Total operation time: the time from the beginning of the skin incision to the end of the operation
^b Single-port establishment time: the time from the beginning of the skin incision to the establishment of pneumoperitoneum
^c Pelvic-abdominal adhesion release time: the time taken to separate adhesions
^d Total hysterectomy time: the time from accessory/fallopian tube resection to uterine disconnection
^e Specimen removal time: the time taken to remove the uterus through vaginal or umbilical fragmentation
^f Stump suture time: the time taken for vaginal stump suturing with a single needle barb
^g Estimated blood loss: collected and evaluated by the intraoperative suction device
^h Fatigue Severity Scale (FSS): score on a 7-point scale (1 = strongly disagree, 7 = strongly agree), where a higher mean value manifests a higher degree of severity of fatigue symptoms [16]
ⁱ Postoperative infection: lower abdominal pain with fever>38°C

ISSN: 1745-6215