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A Double-blinded, Randomized, Placebo-controlled Trial of Antibiotic Prophylaxis in Elective Non-hysterectomy Laparoscopic Surgery for Benign Gynecologic Conditions: A Pilot Study.
Lim, Claire Yinn; Alonso, Anaïs; Koh, Yi Ying; Roydhouse, Stephanie; McCormack, Lalla; Deans, Rebecca; Nesbitt-Hawes, Erin; Rao, Archana; Causer, Louise; Abbott, Jason A.
Afiliación
  • Lim CY; School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia, (Drs. Lim, Roydhouse, McCormack, Deans, Nesbitt-Hawes, and Abbott and Ms. Alonso and Koh); The Gynaecological Research and Clinical Evaluation (GRACE) Unit, Royal Hospital for Women, Sydney, N
  • Alonso A; School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia, (Drs. Lim, Roydhouse, McCormack, Deans, Nesbitt-Hawes, and Abbott and Ms. Alonso and Koh); The Gynaecological Research and Clinical Evaluation (GRACE) Unit, Royal Hospital for Women, Sydney, N
  • Koh YY; School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia, (Drs. Lim, Roydhouse, McCormack, Deans, Nesbitt-Hawes, and Abbott and Ms. Alonso and Koh); The Gynaecological Research and Clinical Evaluation (GRACE) Unit, Royal Hospital for Women, Sydney, N
  • Roydhouse S; School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia, (Drs. Lim, Roydhouse, McCormack, Deans, Nesbitt-Hawes, and Abbott and Ms. Alonso and Koh); The Gynaecological Research and Clinical Evaluation (GRACE) Unit, Royal Hospital for Women, Sydney, N
  • McCormack L; School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia, (Drs. Lim, Roydhouse, McCormack, Deans, Nesbitt-Hawes, and Abbott and Ms. Alonso and Koh); The Gynaecological Research and Clinical Evaluation (GRACE) Unit, Royal Hospital for Women, Sydney, N
  • Deans R; School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia, (Drs. Lim, Roydhouse, McCormack, Deans, Nesbitt-Hawes, and Abbott and Ms. Alonso and Koh); The Gynaecological Research and Clinical Evaluation (GRACE) Unit, Royal Hospital for Women, Sydney, N
  • Nesbitt-Hawes E; School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia, (Drs. Lim, Roydhouse, McCormack, Deans, Nesbitt-Hawes, and Abbott and Ms. Alonso and Koh); The Gynaecological Research and Clinical Evaluation (GRACE) Unit, Royal Hospital for Women, Sydney, N
  • Rao A; Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia (Dr. Rao).
  • Causer L; Kirby Institute, Sydney, New South Wales, Australia (Dr. Causer).
  • Abbott JA; School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia, (Drs. Lim, Roydhouse, McCormack, Deans, Nesbitt-Hawes, and Abbott and Ms. Alonso and Koh); Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia (Dr. Rao). Electronic address: j
J Minim Invasive Gynecol ; 29(8): 992-997, 2022 08.
Article en En | MEDLINE | ID: mdl-35513301
ABSTRACT
STUDY

OBJECTIVE:

To determine the feasibility of a double-blinded randomized, placebo-controlled study in determining the efficacy of antibiotic prophylaxis in preventing postoperative infections (POIs) in elective nonhysterectomy laparoscopic procedures for benign gynecologic conditions.

DESIGN:

Double-blinded, randomized, placebo-controlled trial.

SETTING:

University-affiliated tertiary referral hospital in Sydney, Australia. PATIENTS Women older than 18 years undergoing elective nonhysterectomy laparoscopic procedures for benign gynecologic conditions were eligible for the study and approached.

INTERVENTIONS:

Before surgery, participants were randomized to receive either 2-g cephazolin or placebo (10-mL normal saline) administered by the anesthetist. Participants and other research staff were blinded to group allocation. MEASUREMENTS AND MAIN

RESULTS:

The primary outcome was study feasibility measured by recruitment rates, compliance rates of drug administration, compliance rates of delivery, maintenance of double blinding, and follow-up rates. Secondary outcomes included rate of POIs, length of hospitalization, readmission to hospital, unscheduled presentations to healthcare facilities, and antibiotic-related reactions. Between February 2019 and March 2021, 170 patients were approached with 117 participants (68.8%) recruited and randomized. The study had a high compliance rate of trial drug delivery (95.7%) and a high follow-up rate (99.1%).

CONCLUSION:

This pilot study has demonstrated feasibility of a large-scale study with a recruitment rate of 68% of patients approached and excellent trial drug delivery and follow-up rates. As anticipated, it is underpowered for identifying clinically significant findings for POI rates. A large-scale study is appropriate and essential to determine the health-related risks of antibiotic prophylaxis with an emphasis on antimicrobial stewardship. The sample size for a large-scale study is 1678 participants based on infection rates in this pilot study.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Laparoscopía / Enfermedades de los Genitales Femeninos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Female / Humans Idioma: En Revista: J Minim Invasive Gynecol Asunto de la revista: GINECOLOGIA Año: 2022 Tipo del documento: Article
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Laparoscopía / Enfermedades de los Genitales Femeninos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Female / Humans Idioma: En Revista: J Minim Invasive Gynecol Asunto de la revista: GINECOLOGIA Año: 2022 Tipo del documento: Article