Claudia C López1, José F De Los Ríos1, Yenyffer González1, Elsa María Vásquez-Trespalacios2, Daniel Serna1, Adriana Arango1, Carolina Cifuentes1, Ricardo Vásquez1, Juan D Castañeda1, Luis A Almanza1, Luis A Jiménez1. 1. Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia. 2. Clinica del Prado (Drs. López, De Los Ríos, Arango, Cifuentes, Vásquez, Castañeda, Almanza, and Jiménez), Medellín, Colombia, and the School of Medicine (Drs. González, Vásquez-Trespalacios, and Serna), CES University, Medellín, Colombia.. Electronic address: evasquez@ces.edu.co.
Abstract
STUDY OBJECTIVE: To determine the surgical time, suture time, presence of postoperative dyspareunia, and complications that occur after closing the vaginal cuff with a barbed suture compared with conventional suture. DESIGN: A randomized, controlled clinical trial (Canadian Task Force classification I). SETTING:Private gynecologic clinic in Medellin, Colombia. PATIENTS: One hundred fifty women who underwent total laparoscopic hysterectomy for benign pathology. INTERVENTIONS: The patients underwent total laparoscopic hysterectomy with intracorporeal closure of the vaginal cuff and were randomized to 2 groups, 1 using a barbed suture (V-Loc 90; Medtronic/Covidien, New Haven, CT) and 1 using polyglactin 910 (coated Vicryl suture; Ethicon/Johnson & Johnson, New Brunswick, NJ). MEASUREMENTS AND MAIN RESULTS: The total operative time, closing time of the vaginal vault, presence of complications in the cuff, and incidence of postoperative dyspareunia were recorded. The patients were evaluated at a postoperative office visit 2 weeks after the procedure and by telephone interview at 24 weeks. Seventy-five patients were included in the barbed suture group and 75 patients in the polyglactin 910 group. The average time to complete the suture of the vaginal cuff was 12.01 minutes (± 5.37 standard deviation) for the barbed suture group versus 13.49 minutes (± 6.48) in the polyglactin 910 group (95% confidence interval, -.44 to 3.4; p = .130). Blood loss was 31.56 ± 22.93 mL in the barbed suture group versus 30.82 ± 21.75 mL in the polyglactin 910 group (95% confidence interval, -7.95 to 6.47; p = .840). The frequency of postoperative events such as hematoma, cellulitis, cuff dehiscence, fever, emergency consultation, and hospitalization was not statistically significant between groups. No statistically significant difference was found regarding deep dyspareunia at 24 postoperative weeks. CONCLUSION: No differences were found in surgical time or frequency of adverse events when comparing patients after vaginal cuff closure with barbed suture versus polyglactin 910.
RCT Entities:
STUDY OBJECTIVE: To determine the surgical time, suture time, presence of postoperative dyspareunia, and complications that occur after closing the vaginal cuff with a barbed suture compared with conventional suture. DESIGN: A randomized, controlled clinical trial (Canadian Task Force classification I). SETTING: Private gynecologic clinic in Medellin, Colombia. PATIENTS: One hundred fifty women who underwent total laparoscopic hysterectomy for benign pathology. INTERVENTIONS: The patients underwent total laparoscopic hysterectomy with intracorporeal closure of the vaginal cuff and were randomized to 2 groups, 1 using a barbed suture (V-Loc 90; Medtronic/Covidien, New Haven, CT) and 1 using polyglactin 910 (coated Vicryl suture; Ethicon/Johnson & Johnson, New Brunswick, NJ). MEASUREMENTS AND MAIN RESULTS: The total operative time, closing time of the vaginal vault, presence of complications in the cuff, and incidence of postoperative dyspareunia were recorded. The patients were evaluated at a postoperative office visit 2 weeks after the procedure and by telephone interview at 24 weeks. Seventy-five patients were included in the barbed suture group and 75 patients in the polyglactin 910 group. The average time to complete the suture of the vaginal cuff was 12.01 minutes (± 5.37 standard deviation) for the barbed suture group versus 13.49 minutes (± 6.48) in the polyglactin 910 group (95% confidence interval, -.44 to 3.4; p = .130). Blood loss was 31.56 ± 22.93 mL in the barbed suture group versus 30.82 ± 21.75 mL in the polyglactin 910 group (95% confidence interval, -7.95 to 6.47; p = .840). The frequency of postoperative events such as hematoma, cellulitis, cuff dehiscence, fever, emergency consultation, and hospitalization was not statistically significant between groups. No statistically significant difference was found regarding deep dyspareunia at 24 postoperative weeks. CONCLUSION: No differences were found in surgical time or frequency of adverse events when comparing patients after vaginal cuff closure with barbed suture versus polyglactin 910.