Vaginal packing after laparoscopic sacrocolpopexy and surgical outcome after one year: A randomized controlled trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00669806%3A_____%2F25%3A10503923" target="_blank" >RIV/00669806:_____/25:10503923 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11140/25:10503923

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=oOTyK~d~lY" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=oOTyK~d~lY</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/aogs.70067" target="_blank" >10.1111/aogs.70067</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Vaginal packing after laparoscopic sacrocolpopexy and surgical outcome after one year: A randomized controlled trial

Popis výsledku v původním jazyce

INTRODUCTION: While the role of vaginal packing following vaginal reconstructive surgery and vaginal hysterectomy was well-explored, data regarding laparoscopic reconstructive surgery are lacking. No effect on early postoperative pain, complications, and satisfaction after laparoscopic sacrocolpopexy (LSC) was observed as presented earlier. No data concerning the effect of vaginal packing on the surgical outcome of LSC exist. Our objective was to test the hypothesis that vaginal packing after laparoscopic sacrocolpopexy is associated with a reduced risk of pelvic organ prolapse recurrence. MATERIAL AND METHODS: All women planned for laparoscopic sacrocolpopexy for pelvic organ prolapse (POPQ stage &gt;2) in the period 11/2016-6/2022 were included in this randomized controlled trial. Those that underwent other surgery, concomitant vaginal surgery, or where the vagina was opened (e.g., during concurrent hysterectomy) were excluded. The women randomly received vaginal packing after the surgery. The primary outcome was defined as prolapse beyond the hymen, symptomatic prolapse, or retreatment in one-year follow-up. Secondary outcomes included anatomical recurrence, quality of life, and complications. CLINICAL TRIAL REGISTRATION: Registered on October 21, 2016, initial participant enrollment on November 14, 2016, clinical trial identification number: NCT02943525, URL of the registration site: https://clinicaltrials.gov/study/NCT02943525. RESULTS: Four hundred and fifty-five (89%) women completed the one-year follow-up. Vaginal pack was inserted in 214 (47%) women. The groups did not differ in most preoperative characteristics, except BMI (26.2 +- 3.4 vs. 26.9 +- 3.6, p = 0.008), preoperative POPDI (64.6 vs. 77.7, p = 0.004), operative time (103 vs. 111 min, p &lt; 0.001), and estimated blood loss (137 vs. 157 mL, p = 0.029), which all were higher in the packing group. No differences in the primary outcome (2.8 vs. 1.7%, p = 0.527) nor any of the recorded variables including the POPQ points position, anatomical recurrence, PGI-I, ICIQ-UI, PFDI, PISQ-12 and complication rate were observed between the groups. No differences in surgical outcomes in subgroups according to concomitant surgery on the uterus (previous hysterectomy, concomitant supracervical hysterectomy, sacrohysterocolpopexy) were observed. There was no difference in the rate of complications. No mesh exposure was observed. CONCLUSIONS: Vaginal packing after laparoscopic sacrocolpopexy is not associated with improved surgical outcomes expressed in anatomic recurrence, composite surgical failure, or quality of life. In light of Enhanced Recovery After Surgery recommendations, routine vaginal packing after laparoscopic sacrocolpopexy cannot be recommended.

Název v anglickém jazyce

Vaginal packing after laparoscopic sacrocolpopexy and surgical outcome after one year: A randomized controlled trial

Popis výsledku anglicky

INTRODUCTION: While the role of vaginal packing following vaginal reconstructive surgery and vaginal hysterectomy was well-explored, data regarding laparoscopic reconstructive surgery are lacking. No effect on early postoperative pain, complications, and satisfaction after laparoscopic sacrocolpopexy (LSC) was observed as presented earlier. No data concerning the effect of vaginal packing on the surgical outcome of LSC exist. Our objective was to test the hypothesis that vaginal packing after laparoscopic sacrocolpopexy is associated with a reduced risk of pelvic organ prolapse recurrence. MATERIAL AND METHODS: All women planned for laparoscopic sacrocolpopexy for pelvic organ prolapse (POPQ stage &gt;2) in the period 11/2016-6/2022 were included in this randomized controlled trial. Those that underwent other surgery, concomitant vaginal surgery, or where the vagina was opened (e.g., during concurrent hysterectomy) were excluded. The women randomly received vaginal packing after the surgery. The primary outcome was defined as prolapse beyond the hymen, symptomatic prolapse, or retreatment in one-year follow-up. Secondary outcomes included anatomical recurrence, quality of life, and complications. CLINICAL TRIAL REGISTRATION: Registered on October 21, 2016, initial participant enrollment on November 14, 2016, clinical trial identification number: NCT02943525, URL of the registration site: https://clinicaltrials.gov/study/NCT02943525. RESULTS: Four hundred and fifty-five (89%) women completed the one-year follow-up. Vaginal pack was inserted in 214 (47%) women. The groups did not differ in most preoperative characteristics, except BMI (26.2 +- 3.4 vs. 26.9 +- 3.6, p = 0.008), preoperative POPDI (64.6 vs. 77.7, p = 0.004), operative time (103 vs. 111 min, p &lt; 0.001), and estimated blood loss (137 vs. 157 mL, p = 0.029), which all were higher in the packing group. No differences in the primary outcome (2.8 vs. 1.7%, p = 0.527) nor any of the recorded variables including the POPQ points position, anatomical recurrence, PGI-I, ICIQ-UI, PFDI, PISQ-12 and complication rate were observed between the groups. No differences in surgical outcomes in subgroups according to concomitant surgery on the uterus (previous hysterectomy, concomitant supracervical hysterectomy, sacrohysterocolpopexy) were observed. There was no difference in the rate of complications. No mesh exposure was observed. CONCLUSIONS: Vaginal packing after laparoscopic sacrocolpopexy is not associated with improved surgical outcomes expressed in anatomic recurrence, composite surgical failure, or quality of life. In light of Enhanced Recovery After Surgery recommendations, routine vaginal packing after laparoscopic sacrocolpopexy cannot be recommended.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30214 - Obstetrics and gynaecology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Acta Obstetricia et Gynecologica Scandinavica

ISSN

0001-6349

e-ISSN

1600-0412

Svazek periodika

104

Číslo periodika v rámci svazku

12

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

8

Strana od-do

2331-2338

Kód UT WoS článku

001591528000001

EID výsledku v databázi Scopus

2-s2.0-105018628856