Loop Excision for Precancers of the Uterine Cervix: Local or General Anaesthetic?

Abstract

Aim: In Germany, treatment of HSIL or AIS of the uterine cervix by loop excision is performed almost exclusively under general anaesthesia (GA). International studies and guidelines show high acceptance of local anaesthesia (LA) due to hermeneutic, medical, and economic factors. We performed an observational comparative study aiming to prove advantages of local anaesthesia within the German health system.

Patients and methods: In a prospective observational study, patients diagnosed with HSIL or AIS of the uterine cervix were treated at the Institute for Cytology and Dysplasia, Berlin, by loop excision in 2021. We started with a feasibility study : 303 patients diagnosed with HSIL/AIS of the uterine cervix and her colposcopist answered an electronic questionnaire with respect to loop excision under LA. Since we found a high acceptance for LA in patients and colposcopists, we initiated a comparative study LA vs. GA: 322 patients underwent loop excision and selected their mode of anaesthesia: n = 206 LA vs. n = 116 GA. 114 patients of the feasibility study had to undergo loop excision and became part of the comparative study (n = 79 for the LA group, n = 35 for the GA group). All patients received a standardised questionnaire to document their pain score within 24 h after treatment on a visual analogue scale, i.e. VAS, between 0 and 100. 178 patients of the LA group and 80 patients of the GA group completed and returned the questionnaire and form the cohort for our comparison of LA vs. GA. With 191 of these 258 patients, i.e. 74%, a telephone survey was performed to ask for patient satisfaction and the rates of recurrence after a mean interval of 1 year post surgery. We postulate that there will be no clinically relevant significant difference in satisfaction and postoperative pain between patients in the LA group and the GA group.

Results: In the feasibility study , 90% (272 of 303) of patients diagnosed with HSIL or AIS were considered eligible for LA by their colposcopists. 75% (227 of 303) of patients were open to loop excision under LA. In the comparative study , 63 of 206 women of the LA group were interviewed preoperatively: 89% would accept a pain score above 20 during the procedure, 33% a pain score above 50 and 11% of max. 20. Postoperatively, the median VAS pain score for loop excision under local anaesthesia was 13.1 in 178 patients, and pain during injection of local anaesthesia was 20.9 (p < 0.001). The VAS pain score 20 minutes post surgery did not differ significantly between 178 patients after local anaesthesia versus 80 patients after general anaesthesia (p = 0.09). The surgeons estimated the patient's pain significantly less than the patients themselves with an underestimate of -14.63 points on the VAS (p < 0.001). Within 7 days following loop excision under LA, 95.5% of 178 patients would choose local anaesthesia as their preferred method for a potential repeat loop excision, 8.8% of which would like additional painkillers, and 4.5% would choose general anaesthesia.In a telephone follow-up survey of 133 women from the LA group after a mean of 12 months post surgery, 97% were "satisfied" or "very satisfied" with the treatment carried out. For patient satisfaction and postoperative pain, no clinically relevant significant difference was seen between the LA and the GA group.The rate of secondary bleeding (6.7% vs. 8.1%, p = 0.72), recurrence of HSIL/AIS (3.6% vs. 5.2%, p = 0.62), and the distribution of the histopathological R status (R0 89.5% vs. 81.1%, p = 0.73; R1 5.3% vs.12.2%, p = 0.57, Rx 4.1% vs. 5.4%, p = 0.65) showed no significant difference when comparing the LA group versus the GA group.

Conclusion: Following loop excision under local anaesthesia, more than 95% of patients would choose this method again for repeat surgery. One year post surgery, 97% of the patients were "satisfied" or "very satisfied" with the treatment under local anaesthesia. Offering local anaesthesia for loop excision to patients should be mandatory and included in current guidelines.

Keywords: CIN; Loop excision; local anaesthesia.

Fig. 1

Fig. 1 Individual assessment of contraindications for local anaesthesia by the treating colposcopists. Survey of treating colposcopists on clinical and psychological contraindications in their patients (n = 303) to surgical therapy of HSIL under local anaesthesia by electronic questionnaire.

Fig. 2

Fig. 2 Composition of the cohorts for the feasibility study and the comparative study.

Fig. 3

Fig. 3 Maximum tolerable pain during surgery with local anaesthesia stated prior to the procedure. Frequency distribution of each preoperative statement on the maximum tolerable pain for the patient during the operation under local anaesthesia of patients operated on under local anaesthesia (n = 63) on a scale of 1–100. Questionnaire by the practitioners.

Fig. 4

Fig. 4 Injection pain and surgery pain stated after the procedure. Comparison of subjectively perceived pain during injection of local anaesthesia versus subjectively perceived pain during loop excision, laser treatment, and haemostasis of patients operated on under local anaesthesia (n = 178) using t-test for independent samples. Survey by postoperative questionnaire.

Fig. 5

Fig. 5 Comparison of indicated pain intensities 20 minutes postoperatively LA group versus GA group. Pain intensity represented 20 minutes postoperatively in patients operated under local anaesthesia (n = 178) versus patients operated under general anaesthetic (n = 80) with HSIL using a t-test for independent samples. Postoperative interview by questionnaire.

Fig. 6

Fig. 6 Presumed vs. actually perceived pain during the operation. Discrepancy between pain intensity of patients operated on under local anaesthesia as presumed by the practitioners and actually perceived by the patient (n = 178). Postoperative questionnaire of patients and practitioners by questionnaire. Comparison by a t-test for independent samples.

Fig. 7

Fig. 7 Desired type of anaesthesia in case of required repeat operation in the LA group. Frequency distribution of responses to the question which anaesthetic technique the patient would choose in case of need for a repeat operation of HSIL. Postoperative questionnaire of patients operated under local anaesthesia within 7 days postoperatively (n = 178).

Fig. 8

Fig. 8 Treatment satisfaction after a median postoperative follow-up of 12 months LA group versus GA group. Comparison of treatment satisfaction for cervical dysplasia approximately 12 months after surgical therapy. Survey by telephone questionnaire. Comparison of both groups (LA n = 133 vs. GA n = 58) by means of the nonparametric Mann–Whitney test (n = 191).

Fig. 9

Fig. 9 Histopathological R status of the excised tissue for the LA group (n = 178) versus the GA group (n = 80). Comparison of both groups (LA vs. GA) with respect to histopathological R status. R0 = cranial resection edge free, RX = resection edge unclear, R1 = HSIL/AIS up to cranial resection edge (n = 258). Comparison of both groups by means of the nonparametric Mann-Whitney test.

Fig. 10

Fig. 10 Recurrence rate after a median postoperative follow-up of 12 months for the LA group versus the GA group. Comparison of recurrence/persistence rate of dysplasia in the operated patients after approximately 12 months. Survey by telephone questionnaire. Comparison of both groups (LA n = 133 vs. GA n = 58) by means of the nonparametric Mann–Whitney test (n = 191).

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Abb. 1 Individuelle Beurteilung der Kontraindikationen für Lokalanästhesie durch die behandelnden Kolposkopiker*innen. Umfrage mittels eines elektronischen Fragebogens bei behandelnden Kolposkopiker*innen zu klinischen und psychischen Kontraindikationen einer operativen Therapie der HSIL in Lokalanästhesie ihrer Patientinnen (n = 303).

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Abb. 2 Zusammensetzung der Kohorten für Machbarkeitsstudie und Vergleichsstudie.

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Abb. 3 Präoperativ erfragter, maximal tolerierbarer Schmerz während der OP in Lokalanästhesie. Häufigkeitsverteilung der individuellen präoperativen Angabe des für die Patientin maximal tolerierbaren Schmerzes während der Operation in Lokalanästhesie von in Lokalanästhesie operierten Patientinnen (n = 63) auf einer Skala von 1 bis 100. Befragung durch die Behandler*innen.

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Abb. 4 Postoperativ erfragter Injektionsschmerz und OP-Schmerz. Vergleich des subjektiv empfundenen Schmerzes während der Injektion des Lokalanästhetikums versus den subjektiv empfundenen Schmerz während der Schlingenexzision, Laserbehandlung und Blutstillung von in Lokalanästhesie operierter Patientinnen (n = 178) mittels t-test für unabhängige Stichproben. Befragung mittels eines postoperativen Fragebogens.

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Abb. 5 Vergleich der angegebenen Schmerzstärken 20 Minuten postoperativ LA-Gruppe versus AA-Gruppe. Darstellung der 20 Minuten postoperativ angegebenen Schmerzstärke von in Lokalanästhesie operierten Patientinnen (n = 178) versus in Allgemeinanästhesie operierte Patientinnen (n = 80) mit einer HSIL. Vergleich mittels t-test für unabhängige Stichproben. Postoperative Befragung mittels Fragebogen.

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Abb. 6 Vermuteter vs. real empfundenen Schmerz während der Operation. Diskrepanz der durch die Behandler*innen vermuteten und tatsächlich durch die Patientin empfundenen Schmerzintensität von in Lokalanästhesie operierter Patientinnen (n = 178). Postoperative Befragung der Patientinnen sowie der Behandler*innen mittels Fragebogen. Vergleich mittels t-test für unabhängige Stichproben.

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Abb. 7 Erwünschter Betäubungsmodus im Falle der Notwendigkeit eines erneuten Eingriffes in LA-Gruppe. Häufigkeitsverteilung der Antworten auf die Frage, welches Betäubungsverfahren die Patientin im Falle einer erneut notwendigen Operation einer HSIL wählen würde. Postoperative Befragung mittels Fragebogen von in Lokalanästhesie operierter Patientinnen innerhalb von 7 Tagen postoperativ (n = 178).

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Abb. 8 Behandlungszufriedenheit nach einer mittleren postoperativen Nachbeobachtung von 12 Monaten LA-Gruppe versus AA-Gruppe. Erhebung mittels eines telefonischen Fragebogens. Vergleich beider Gruppen (LA n = 133 vs. AA n = 58) mittels eines nicht parametrischen Mann-Whitney-Tests (n = 191).

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Abb. 9 Histopathologischer R-Status des Exzidates für LA-Gruppe (n = 178) versus AA-Gruppe (n = 80). Vergleich beider Gruppen (LA vs. AA) bezüglich des histopathologischen R-Status. R0 = kranialer Resektionsrand frei, RX = Resektionsrand unklar, R1 = HSIL/AIS bis in den kranialen Resektionsrand (n = 258).

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Abb. 10 Rezidivhäufigkeit nach einer mittleren postoperativen Nachbeobachtung von 12 Monaten für LA-Gruppe versus AA-Gruppe. Vergleich Rezidiv/Persistenzhäufigkeit einer Dysplasie der operierten Patientinnen nach ca. 12 Monaten. Erhebung mittels telefonischen Fragebogens. Vergleich beider Gruppen (LA n = 133 vs. AA n = 58) mittels eines nicht parametrischen Mann-Whitney-Tests (n = 191).