Mourits 2010.

Methods	Multicentre randomised controlled trial with 2:1 intervention:control randomisation Study dates: 1 February 2007 to 15 January 2009
Participants	283 women assessed for eligibility, 4 excluded as did not fulfil inclusion criteria: 2 in each group. 94 in laparotomy group, mean age 63 (range 39–86), mean BMI 28 (range 19–48), stage I disease 75/185 (87.2%). 185 in laparoscopy group, mean age 62 (range 40–89), mean BMI 29 (range 17–55), stage I disease 130/185 (87.2%). Inclusion criteria: participants: histologically confirmed grade I–II EC or complex atypical hyperplasia, clinically confined to the uterine corpus (i.e. clinical stage I), aged > 18 years, prior to study entry "an endocervical curettage is performed to make sure that the participant has clinical stage I disease and the cervix is not involved". Exclusion criteria: non‐endometrioid adenocarcinoma histological types, uterine size larger than that expected at 12 weeks' pregnancy (original protocol stated uterine size > 10 weeks' gestation), cardiopulmonary contraindications for laparoscopy or laparotomy, stage II–IV disease.
Interventions	Intervention: TLH, bilateral salpingo‐oophorectomy, peritoneal washings. All TLH procedures were done by 24 certified surgeons who achieved sufficient laparoscopic skills for performing a TLH. Control: laparotomy, TAH, bilateral salpingo‐oophorectomy, peritoneal washings. TAH procedures were done by fully trained, established, gynaecological surgeons; any 1 of the 24 certified surgeons or a colleague.
Outcomes	Primary outcome: Major complication rate Secondary outcomes: Minor complications Treatment‐related outcomes QoL: SF‐36, SAQ, Body Image Scale and VAS at baseline, 6 weeks, 3 and 6 months postsurgery
Notes	Questionnaire regarding: QoL SF‐36. The SAQ "was completed only by patients that had been sexually active in the month before receiving the questionnaire". Follow‐up: outcomes assessed "Pre‐operatively, after 6 weeks, and after 3 and 6 months". No lymphadenectomy performed. Adjuvant radiotherapy: 38 (20.0%) in laparoscopy group, 25 (26.6%) in laparotomy group. 2 centres did not comply with randomisation procedure and were banned from participation shortly after start of study. These centres assumed an advantage for laparoscopy and intended to first offer laparoscopy and subsequently randomise women who had no preference. 1 of these centres had not yet randomised women. The other centre randomised 4 women before beginning the selective randomisation; therefore, these women were not excluded from the study. According to protocol, uterine size > 10 weeks' gestation was a contraindication, but trial included uterine size > 12 weeks' gestation. Conversion to laparotomy occurred in 20/185 (10.8%) of laparoscopic procedures. TLH was associated with significantly less blood loss (P < 0.0001), less use of pain medication (P < 0.0001), shorter hospital stay (P < 0.0001) and faster recovery (P = 0.002), but procedure took longer than TAH (P < 0.0001). Participants who had laparoscopy scored significantly higher on the physical functioning sub scale of the SF‐36 at 6 weeks, and on the role‐physical sub scale at 3 months after the procedure. Participants who had laparotomy scored significantly higher on the vitality sub scale of the mental dimension 3 months after surgery. No differences for the other subscales.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation by sequential number generation done centrally in alternate blocks of 6 and 3 participants, with stratification by trial centre.
Allocation concealment (selection bias)	Low risk	Central allocation
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	283/283 (100%) participants analysed Loss to follow‐up: documented. "All adverse events are followed until they have abated, or until a stable situation has been reached". Missing data: documented and addressed.
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement, although according to protocol, secondary outcome measures were costs and cost‐effectiveness and included additional home care, but these were not reported.
Other bias	Unclear risk	Insufficient information to assess whether any additional bias was present.