Authors’ reply re: Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a daycare procedure: a randomised controlled trial

Baekelandt, Jan; Mulder, Peter A. De; Roy, Ilse Le; Mathieu, Chantal; Laenen, Annouschka; Enzlin, Paul; Weyers, Steven; Mol, Ben W.; Bosteels, Jan

doi:10.1111/1471-0528.15744

Cited by 4 publications

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References 2 publications

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“…No formal evaluation of the success of blinding was conducted, as no existing method for the assessment of blinding in clinical trials is regarded as standard. 29,30…”

Section: Randomisation Blinding and Treatment Allocationmentioning

confidence: 99%

Impact of different intraoperative CO₂ pressure levels (8 and 15 mmHg) during laparoscopic hysterectomy performed due to benign uterine pathologies on postoperative pain and arterial pCO₂: a prospective randomised controlled clinical trial

et al. 2019

BJOG

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Objective To compare the effects of two different intraoperative CO2 pressures (8 and 15 mmHg) during laparoscopic hysterectomy for benign uterine pathologies in terms of postoperative abdominal and shoulder pain, laparoscopy‐mediated vegetative alterations, pain medication requirement, arterial CO2 pressure (pCO2), surgical parameters, and safety. Design Prospective randomised controlled study. Setting German university hospital. Population Female patients undergoing laparoscopic hysterectomy for benign uterine pathologies. Methods Patients were randomised to a standard pressure (SP; 15 mmHg, control) or low‐pressure (LP; 8 mmHg, experimental) group. Main outcome measures Primary outcomes were postoperative abdominal and shoulder pain intensities, measured via numeric rating scale (NRS) and vegetative parameters (fatigue, nausea, vomiting, bloating) at 3, 24, and 48 hours postoperatively. Secondary outcomes were pain medication requirement (mg) and arterial pCO2 (mmHg). Surgical parameters and intra‐ and postoperative complications were also recorded. Results In total, 178 patients were included. Patients in the LP group (n = 91) showed significantly lower postoperative abdominal and shoulder pain scores, fewer vegetative alterations, lower pain medication requirements, a shorter postoperative hospitalization, and lower intra‐ and postoperative arterial pCO2 values compared with the SP group (n = 87; P ≤ 0.01). No differences in intra‐ and postoperative complications were observed between groups. Conclusions Low‐pressure laparoscopy seems to be an effective and safe technique for the reduction of postoperative pain and laparoscopy‐induced metabolic and vegetative alterations following laparoscopic hysterectomy for benign indications. Tweetable abstract Low‐pressure laparoscopy seems to be an effective and safe technique for reduction of pain following laparoscopic hysterectomy.

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“…No formal evaluation of the success of blinding was conducted, as no existing method for the assessment of blinding in clinical trials is regarded as standard. 29,30…”

Section: Randomisation Blinding and Treatment Allocationmentioning

confidence: 99%

Impact of different intraoperative CO₂ pressure levels (8 and 15 mmHg) during laparoscopic hysterectomy performed due to benign uterine pathologies on postoperative pain and arterial pCO₂: a prospective randomised controlled clinical trial

et al. 2019

BJOG

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Authors’ reply re: Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a daycare procedure: a randomised controlled trial

Baekelandt

Mulder

Roy

et al. 2019

BJOG

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Does transvaginal natural orifice transluminal endoscopic surgery affect female sexual function?: a prospective cohort study

Lin

et al. 2023

BMC Women's Health

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Background To evaluate the effect of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) on female sexual function. Methods: The trial was registered at the Chinese Clinical Trial Registry (ChiCTR2100050887, 07/09/2021). In this prospective cohort study, we prospectively analyzed the data of the female sexual function index (FSFI) questionnaire of 130 patients who underwent laparoscopy in Chengdu Women’s and Children’s Central Hospital due to gynecological benign diseases. The patients were assigned to the vNOTES group and the control group (underwent traditional laparoscopic surgery or transumbilical laparoendoscopic single-site surgery). Results: There were 4 cases dropout in the vNOTES group and 2 cases dropout in the control group. There was no difference in the ages (31.70 ± 5.02 vs. 30.37 ± 5.74, P>0.05), BMI (body mass index, 21.76 ± 3.16 vs. 23.30 ± 2.69, P>0.05), Education level, surgical types, and FSFI scores (22.31 ± 2.25 vs. 21.55 ± 3.38) between the vNOTES group and the control group before surgery. There was no difference in FSFI scores six months postoperation between the vNOTES group and the control group (21.61 ± 3.22 vs. 20.99 ± 3.26, P>0.05), and there was no difference in FSFI scores pre- and six months postoperation in vNOTES group (21.61 ± 3.22 vs. 22.31 ± 2.25, P>0.05). The time to start sexual life after surgery in the vNOTES group was later than that in the control group (39.34 ± 0.71 d versus 37.86 ± 0.69 d, P < 0.05). Conclusions: vNOTES has no significant adverse effect on female sexual function, however, the time to start sexual life after vNOTES is later than that after trans-abdominal laparoscopy.

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Authors’ reply re: Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a daycare procedure: a randomised controlled trial

Cited by 4 publications

References 2 publications

Impact of different intraoperative CO₂ pressure levels (8 and 15 mmHg) during laparoscopic hysterectomy performed due to benign uterine pathologies on postoperative pain and arterial pCO₂: a prospective randomised controlled clinical trial

Impact of different intraoperative CO₂ pressure levels (8 and 15 mmHg) during laparoscopic hysterectomy performed due to benign uterine pathologies on postoperative pain and arterial pCO₂: a prospective randomised controlled clinical trial

Authors’ reply re: Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a daycare procedure: a randomised controlled trial

Does transvaginal natural orifice transluminal endoscopic surgery affect female sexual function?: a prospective cohort study

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Authors’ reply re: Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a daycare procedure: a randomised controlled trial

Cited by 4 publications

References 2 publications

Impact of different intraoperative CO2 pressure levels (8 and 15 mmHg) during laparoscopic hysterectomy performed due to benign uterine pathologies on postoperative pain and arterial pCO2: a prospective randomised controlled clinical trial

Impact of different intraoperative CO2 pressure levels (8 and 15 mmHg) during laparoscopic hysterectomy performed due to benign uterine pathologies on postoperative pain and arterial pCO2: a prospective randomised controlled clinical trial

Authors’ reply re: Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a daycare procedure: a randomised controlled trial

Does transvaginal natural orifice transluminal endoscopic surgery affect female sexual function?: a prospective cohort study

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Impact of different intraoperative CO₂ pressure levels (8 and 15 mmHg) during laparoscopic hysterectomy performed due to benign uterine pathologies on postoperative pain and arterial pCO₂: a prospective randomised controlled clinical trial

Impact of different intraoperative CO₂ pressure levels (8 and 15 mmHg) during laparoscopic hysterectomy performed due to benign uterine pathologies on postoperative pain and arterial pCO₂: a prospective randomised controlled clinical trial